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Addiction expert says CBD may help people cut cannabis use
PARIS – Following the suspension of the decree that banned the sale of cannabidiol (CBD) flowers, raw cannabis is again available in France for over-the-counter sales. The “feel-good” plant is praised for its relaxing properties.
The suspension of the ban, which lasted for 3 weeks, is a mixed blessing for businesses that sell CBD-based products in France. Professional organizations in this booming sector filed a petition with France’s highest administrative court, the Council of State. At the end of January, the court suspended the government decree that banned the sale of cannabis-derived CBD flowers and leaves; however, it has yet to hand down a final decision as to the legality of the decree.
In just a few years, numerous shops have opened across France. They no longer have to settle for selling processed CBD products such as chocolate, oils, cookies – even wine. They can resume the sale of CBD hemp, which mainly comes in clusters of flower buds and can be smoked or used as an infusion.
Cannabis-derived CBD must have less than 0.2% tetrahydrocannabinol (THC) to be considered “feel-good hemp,” which is used in various consumer goods (such as food, cosmetics, and e-cigarette liquids) and is praised for its calming effects. But not all hemp is the same. Medical hemp, which is currently in clinical trials, combines varying doses of CBD and THC. And then there is THC-rich psychotropic hemp, which is illegal to sell.
The government’s decree cites health concerns as a justification for the ban. While uncertainties remain, “research studies have shown that CBD acts on dopamine and serotonin receptors in the brain. ... Therefore, using CBD can produce psychoactive, sedative, and sleep-inducing effects.” In addition to a preventive approach, the authorities cite the difficulties in distinguishing cannabis-derived CBD from THC-rich illegal cannabis – difficulties that complicate efforts in the war on drugs.
The government’s position sows confusion among consumers, who are attracted by the arguments in favor of CBD and intrigued by the promise of the substance’s calming effects. This confusion is heightened by the fact that there are not enough scientific data either to declare that CBD poses a real risk or, alternatively, to confirm that it has beneficial effects. While some studies have suggested that CBD has a potential benefit for treating anxiety, pain, and sleep problems, others suggest that it may instead be a placebo effect.
What actual benefit can be expected from CBD-derived products, in particular from using the plant’s raw extracts? We asked Dan Velea, MD, an addiction psychiatrist in Paris, to give us his thoughts.
What do you think of the government’s position of banning the sale of cannabis-derived CBD flowers and leaves?
Dr. Velea: I don’t understand the reasoning behind this ban. Unlike THC, CBD is not an addictive substance. We’ve suspected that CBD had beneficial effects ever since noting that, just like THC, it could bind to the two types of cannabinoid receptors found in our bodies, CB1 and CB2, but without inducing a psychotropic effect or giving rise to dependence.
The CBD-derived products that are available on the market have infinitesimal amounts of THC – the threshold is 0.2% – which pose no risk. These products seem to be a particularly good alternative for certain at-risk users who are looking for a way that will help them cut down on their use of “traditional” cannabis, which has THC. However, due to a lack of research, the benefits of CBD cannot be confirmed.
Now that the decree’s been suspended, we can leave behind the ideological debate that has been built around cannabis in France. It’s time to focus only on discussions based on science. On that note, we also have to encourage people to do more research into cannabis’s therapeutic value.
You believe that CBD can help people cut down on their cannabis use. Is that based on what you see in your practice as an addiction specialist?
Dr. Velea: Of course, they don’t get the same dazzling effect that’s produced by THC, very high concentrations of which are often found in cannabis. But for them, the sensation they get from CBD is still pleasant. They describe it as having a soothing and fun effect; they quite like it. Given that the vast majority of people use cannabis recreationally, we can consider that this effect is no small benefit.
Even those who are highly dependent prefer to alternate, using CBD during the day and having just one THC joint in the evening. This makes them feel a lot better. In addition, it clearly reduces the health risks. In my opinion, CBD can be viewed as an alternative for people whose cannabis use is problematic. If a patient asks me about it, I give them an unequivocal answer: There are fewer risks associated with CBD than with regular cannabis.
Isn’t there still a risk for abuse? A dose of cannabidiol that shouldn’t be exceeded?
Dr. Velea: Honestly, apart from the harmful effects of smoking CBD, I don’t see any health risks associated with its use. I’ve never had a patient present with complaints after using these products. No one has ever told me that they became addicted or experienced psychotropic effects. There are no changes in behavior, even at high doses. It should be mentioned that World Health Organization experts hold that there’s no abuse or dependence potential associated with the use of pure CBD. Furthermore, they say that the product is generally well tolerated.
What other actual benefits does CBD have? People mention its relaxing, even anxiolytic, effects.
Dr. Velea: CBD-derived products are praised for their relaxing properties, which particularly help improve one’s sleep. It’s a question of knowing whether these are actual benefits or whether a placebo effect is involved here – something that would be enhanced in a person who firmly believes that these products bring about a sense of well-being. Even when CBD is used for pain relief, we can’t rule out the placebo effect as playing an important role in the outcome.
Some patients with serious diseases have been able to find comfort by using CBD. However, because there haven’t been any well-designed randomized studies, we’ve never been able to show clearly that the beneficial effect comes from the product itself. It’s also possible that the soothing, muscle-relaxing effect induced by CBD’s stimulation of cannabinoid receptors is actually what’s helping to relieve the pain. But this has yet to be proved.
So, what position can a doctor take toward patients who express their desire to use CBD-derived products?
Dr. Velea: Without reliable studies to back them up, it’s difficult to say. Also, at the moment, there are legal gray areas that don’t allow doctors to take a position. As a result, users are put at a disadvantage and not given the opportunity to make the choice to use CBD-derived products in an informed manner. Even so, I think that as long as we don’t have scientific data, the use of these products must be limited to recreational use with the aim of bringing about relaxation. In the case of a sleep disorder, for example, doctors can’t replace standard therapeutic management aimed at improving the patient’s sleep cycles. For now, the only genuinely interesting aspect of CBD that I can see is that it makes it possible to cut down on the use of THC-containing cannabis.
A version of this article first appeared on Medscape.com.
PARIS – Following the suspension of the decree that banned the sale of cannabidiol (CBD) flowers, raw cannabis is again available in France for over-the-counter sales. The “feel-good” plant is praised for its relaxing properties.
The suspension of the ban, which lasted for 3 weeks, is a mixed blessing for businesses that sell CBD-based products in France. Professional organizations in this booming sector filed a petition with France’s highest administrative court, the Council of State. At the end of January, the court suspended the government decree that banned the sale of cannabis-derived CBD flowers and leaves; however, it has yet to hand down a final decision as to the legality of the decree.
In just a few years, numerous shops have opened across France. They no longer have to settle for selling processed CBD products such as chocolate, oils, cookies – even wine. They can resume the sale of CBD hemp, which mainly comes in clusters of flower buds and can be smoked or used as an infusion.
Cannabis-derived CBD must have less than 0.2% tetrahydrocannabinol (THC) to be considered “feel-good hemp,” which is used in various consumer goods (such as food, cosmetics, and e-cigarette liquids) and is praised for its calming effects. But not all hemp is the same. Medical hemp, which is currently in clinical trials, combines varying doses of CBD and THC. And then there is THC-rich psychotropic hemp, which is illegal to sell.
The government’s decree cites health concerns as a justification for the ban. While uncertainties remain, “research studies have shown that CBD acts on dopamine and serotonin receptors in the brain. ... Therefore, using CBD can produce psychoactive, sedative, and sleep-inducing effects.” In addition to a preventive approach, the authorities cite the difficulties in distinguishing cannabis-derived CBD from THC-rich illegal cannabis – difficulties that complicate efforts in the war on drugs.
The government’s position sows confusion among consumers, who are attracted by the arguments in favor of CBD and intrigued by the promise of the substance’s calming effects. This confusion is heightened by the fact that there are not enough scientific data either to declare that CBD poses a real risk or, alternatively, to confirm that it has beneficial effects. While some studies have suggested that CBD has a potential benefit for treating anxiety, pain, and sleep problems, others suggest that it may instead be a placebo effect.
What actual benefit can be expected from CBD-derived products, in particular from using the plant’s raw extracts? We asked Dan Velea, MD, an addiction psychiatrist in Paris, to give us his thoughts.
What do you think of the government’s position of banning the sale of cannabis-derived CBD flowers and leaves?
Dr. Velea: I don’t understand the reasoning behind this ban. Unlike THC, CBD is not an addictive substance. We’ve suspected that CBD had beneficial effects ever since noting that, just like THC, it could bind to the two types of cannabinoid receptors found in our bodies, CB1 and CB2, but without inducing a psychotropic effect or giving rise to dependence.
The CBD-derived products that are available on the market have infinitesimal amounts of THC – the threshold is 0.2% – which pose no risk. These products seem to be a particularly good alternative for certain at-risk users who are looking for a way that will help them cut down on their use of “traditional” cannabis, which has THC. However, due to a lack of research, the benefits of CBD cannot be confirmed.
Now that the decree’s been suspended, we can leave behind the ideological debate that has been built around cannabis in France. It’s time to focus only on discussions based on science. On that note, we also have to encourage people to do more research into cannabis’s therapeutic value.
You believe that CBD can help people cut down on their cannabis use. Is that based on what you see in your practice as an addiction specialist?
Dr. Velea: Of course, they don’t get the same dazzling effect that’s produced by THC, very high concentrations of which are often found in cannabis. But for them, the sensation they get from CBD is still pleasant. They describe it as having a soothing and fun effect; they quite like it. Given that the vast majority of people use cannabis recreationally, we can consider that this effect is no small benefit.
Even those who are highly dependent prefer to alternate, using CBD during the day and having just one THC joint in the evening. This makes them feel a lot better. In addition, it clearly reduces the health risks. In my opinion, CBD can be viewed as an alternative for people whose cannabis use is problematic. If a patient asks me about it, I give them an unequivocal answer: There are fewer risks associated with CBD than with regular cannabis.
Isn’t there still a risk for abuse? A dose of cannabidiol that shouldn’t be exceeded?
Dr. Velea: Honestly, apart from the harmful effects of smoking CBD, I don’t see any health risks associated with its use. I’ve never had a patient present with complaints after using these products. No one has ever told me that they became addicted or experienced psychotropic effects. There are no changes in behavior, even at high doses. It should be mentioned that World Health Organization experts hold that there’s no abuse or dependence potential associated with the use of pure CBD. Furthermore, they say that the product is generally well tolerated.
What other actual benefits does CBD have? People mention its relaxing, even anxiolytic, effects.
Dr. Velea: CBD-derived products are praised for their relaxing properties, which particularly help improve one’s sleep. It’s a question of knowing whether these are actual benefits or whether a placebo effect is involved here – something that would be enhanced in a person who firmly believes that these products bring about a sense of well-being. Even when CBD is used for pain relief, we can’t rule out the placebo effect as playing an important role in the outcome.
Some patients with serious diseases have been able to find comfort by using CBD. However, because there haven’t been any well-designed randomized studies, we’ve never been able to show clearly that the beneficial effect comes from the product itself. It’s also possible that the soothing, muscle-relaxing effect induced by CBD’s stimulation of cannabinoid receptors is actually what’s helping to relieve the pain. But this has yet to be proved.
So, what position can a doctor take toward patients who express their desire to use CBD-derived products?
Dr. Velea: Without reliable studies to back them up, it’s difficult to say. Also, at the moment, there are legal gray areas that don’t allow doctors to take a position. As a result, users are put at a disadvantage and not given the opportunity to make the choice to use CBD-derived products in an informed manner. Even so, I think that as long as we don’t have scientific data, the use of these products must be limited to recreational use with the aim of bringing about relaxation. In the case of a sleep disorder, for example, doctors can’t replace standard therapeutic management aimed at improving the patient’s sleep cycles. For now, the only genuinely interesting aspect of CBD that I can see is that it makes it possible to cut down on the use of THC-containing cannabis.
A version of this article first appeared on Medscape.com.
PARIS – Following the suspension of the decree that banned the sale of cannabidiol (CBD) flowers, raw cannabis is again available in France for over-the-counter sales. The “feel-good” plant is praised for its relaxing properties.
The suspension of the ban, which lasted for 3 weeks, is a mixed blessing for businesses that sell CBD-based products in France. Professional organizations in this booming sector filed a petition with France’s highest administrative court, the Council of State. At the end of January, the court suspended the government decree that banned the sale of cannabis-derived CBD flowers and leaves; however, it has yet to hand down a final decision as to the legality of the decree.
In just a few years, numerous shops have opened across France. They no longer have to settle for selling processed CBD products such as chocolate, oils, cookies – even wine. They can resume the sale of CBD hemp, which mainly comes in clusters of flower buds and can be smoked or used as an infusion.
Cannabis-derived CBD must have less than 0.2% tetrahydrocannabinol (THC) to be considered “feel-good hemp,” which is used in various consumer goods (such as food, cosmetics, and e-cigarette liquids) and is praised for its calming effects. But not all hemp is the same. Medical hemp, which is currently in clinical trials, combines varying doses of CBD and THC. And then there is THC-rich psychotropic hemp, which is illegal to sell.
The government’s decree cites health concerns as a justification for the ban. While uncertainties remain, “research studies have shown that CBD acts on dopamine and serotonin receptors in the brain. ... Therefore, using CBD can produce psychoactive, sedative, and sleep-inducing effects.” In addition to a preventive approach, the authorities cite the difficulties in distinguishing cannabis-derived CBD from THC-rich illegal cannabis – difficulties that complicate efforts in the war on drugs.
The government’s position sows confusion among consumers, who are attracted by the arguments in favor of CBD and intrigued by the promise of the substance’s calming effects. This confusion is heightened by the fact that there are not enough scientific data either to declare that CBD poses a real risk or, alternatively, to confirm that it has beneficial effects. While some studies have suggested that CBD has a potential benefit for treating anxiety, pain, and sleep problems, others suggest that it may instead be a placebo effect.
What actual benefit can be expected from CBD-derived products, in particular from using the plant’s raw extracts? We asked Dan Velea, MD, an addiction psychiatrist in Paris, to give us his thoughts.
What do you think of the government’s position of banning the sale of cannabis-derived CBD flowers and leaves?
Dr. Velea: I don’t understand the reasoning behind this ban. Unlike THC, CBD is not an addictive substance. We’ve suspected that CBD had beneficial effects ever since noting that, just like THC, it could bind to the two types of cannabinoid receptors found in our bodies, CB1 and CB2, but without inducing a psychotropic effect or giving rise to dependence.
The CBD-derived products that are available on the market have infinitesimal amounts of THC – the threshold is 0.2% – which pose no risk. These products seem to be a particularly good alternative for certain at-risk users who are looking for a way that will help them cut down on their use of “traditional” cannabis, which has THC. However, due to a lack of research, the benefits of CBD cannot be confirmed.
Now that the decree’s been suspended, we can leave behind the ideological debate that has been built around cannabis in France. It’s time to focus only on discussions based on science. On that note, we also have to encourage people to do more research into cannabis’s therapeutic value.
You believe that CBD can help people cut down on their cannabis use. Is that based on what you see in your practice as an addiction specialist?
Dr. Velea: Of course, they don’t get the same dazzling effect that’s produced by THC, very high concentrations of which are often found in cannabis. But for them, the sensation they get from CBD is still pleasant. They describe it as having a soothing and fun effect; they quite like it. Given that the vast majority of people use cannabis recreationally, we can consider that this effect is no small benefit.
Even those who are highly dependent prefer to alternate, using CBD during the day and having just one THC joint in the evening. This makes them feel a lot better. In addition, it clearly reduces the health risks. In my opinion, CBD can be viewed as an alternative for people whose cannabis use is problematic. If a patient asks me about it, I give them an unequivocal answer: There are fewer risks associated with CBD than with regular cannabis.
Isn’t there still a risk for abuse? A dose of cannabidiol that shouldn’t be exceeded?
Dr. Velea: Honestly, apart from the harmful effects of smoking CBD, I don’t see any health risks associated with its use. I’ve never had a patient present with complaints after using these products. No one has ever told me that they became addicted or experienced psychotropic effects. There are no changes in behavior, even at high doses. It should be mentioned that World Health Organization experts hold that there’s no abuse or dependence potential associated with the use of pure CBD. Furthermore, they say that the product is generally well tolerated.
What other actual benefits does CBD have? People mention its relaxing, even anxiolytic, effects.
Dr. Velea: CBD-derived products are praised for their relaxing properties, which particularly help improve one’s sleep. It’s a question of knowing whether these are actual benefits or whether a placebo effect is involved here – something that would be enhanced in a person who firmly believes that these products bring about a sense of well-being. Even when CBD is used for pain relief, we can’t rule out the placebo effect as playing an important role in the outcome.
Some patients with serious diseases have been able to find comfort by using CBD. However, because there haven’t been any well-designed randomized studies, we’ve never been able to show clearly that the beneficial effect comes from the product itself. It’s also possible that the soothing, muscle-relaxing effect induced by CBD’s stimulation of cannabinoid receptors is actually what’s helping to relieve the pain. But this has yet to be proved.
So, what position can a doctor take toward patients who express their desire to use CBD-derived products?
Dr. Velea: Without reliable studies to back them up, it’s difficult to say. Also, at the moment, there are legal gray areas that don’t allow doctors to take a position. As a result, users are put at a disadvantage and not given the opportunity to make the choice to use CBD-derived products in an informed manner. Even so, I think that as long as we don’t have scientific data, the use of these products must be limited to recreational use with the aim of bringing about relaxation. In the case of a sleep disorder, for example, doctors can’t replace standard therapeutic management aimed at improving the patient’s sleep cycles. For now, the only genuinely interesting aspect of CBD that I can see is that it makes it possible to cut down on the use of THC-containing cannabis.
A version of this article first appeared on Medscape.com.
Daylight Savings: How an imposed time change alters your brain, and what you can do
On March 13, most of the United States and Canada will advance the clock an hour to be on Daylight Saving Time. Most other countries in the Northern Hemisphere will do the same within a few weeks; and many countries across the Southern Hemisphere turn the clock back an hour around the same time. A friend of mine, who spent time on Capitol Hill, once told me that whether it’s adjusting to Daylight Saving Time (and losing an hour of sleep) or switching back to Standard Time (and picking up an hour), large numbers of Americans call their member of Congress every season to complain.
Why are so many of us annoyed by the semi-annual resetting of clocks? Those reasons also come into play when we change time zones as we travel, when we work on the night shift, or when we live at higher latitudes, where depressive symptoms from seasonal affective disorder (SAD) can plague us as the period of daylight progressively shortens in winter.
Our internal clock(s)
Each of us has a biological master clock keeping track of where we are in our 24-hour day, making ongoing time-of-day-appropriate physical and neurologic adjustments. We refer to those automatic adjustments as “circadian” rhythms – from the Latin, for “around a day” rhythms.
One of the most important regulated functions that is influenced by this time keeping is our sleep-wake cycle. Our brain’s hypothalamus has a kind of “master clock” that receives inputs directly from our eyes, which is how our brain sets our daily cycle period at about 24 hours.
This master clock turns on a tiny structure in our brains, called the pineal gland, to release more of a sleep-inducing chemical, called melatonin, about the same time every evening. The level of melatonin slowly increases to reach maximum deep sleep in the night, then slowly declines as you advance toward morning awakening. The shift from darkness to daylight in the morning, causing your initial morning awakening, releases the excitatory neuromodulator norepinephrine, which, with other chemicals, “turns on the lights” in your brain.
That works well most of the time – but no one told your brain that you were going to arbitrarily go to bed an hour earlier (or in the fall, later) on Circadian Rhythm Time!
We also obviously shift the time on the mechanical clock – requiring a reset of the brain’s master clock – when we travel across time zones or work the night shift. That type of desynchronization of our master clock from the mechanical clock puts our waking and sleeping behaviors out of sync with the production of brain chemicals that affect our alertness and mood. The result may be that you find yourself tired, but not sleepy, and often grumpy or even depressed. As an example, on average, people who work the night shift are just a little bit more anxious and depressed than people who get up to rise and shine with the sun every morning.
Seasonal affective disorder
An extreme example of this desynchronization of the master clock can manifest as SAD. SAD is a type of depression that’s related to seasonal transitions. The most commonly cited cases of SAD are for the fall-to-winter transition. In North America, its prevalence is significantly influenced by the distance of one’s place of residence from the equator – with about 12 times the impact in Alaska versus Florida. Of note, a weaker effect of latitude has been recorded in Europe, where more settled populations have had thousands of years to biologically and culturally adapt to their seasonal patterns.
What can we do about our clocks being messed with?
The most common treatment for SAD is light therapy, in which patients sit or work under artificial lights in an early-morning period, to try to advance the chemical signaling that controls sleeping and waking. Alas, light therapy doesn’t work for everyone.
Another approach, with or without the lights, is to engage in activities early in the day that produce brain chemicals to contribute to bright and cheerful waking. Those “raring-to-go” brain chemicals include norepinephrine (produced when you encounter novelty and are just having fun), acetylcholine (produced when you are carefully paying attention and are in a learning and remembering mode), serotonin (produced when you are feeling positive and just a little bit euphoric), and dopamine (produced when you feel happy and all is right with the world).
In fact, you would benefit from creating the habit of starting every day with activity that wakes up your brain. I begin my day with computerized brain exercises that are attentionally demanding, filled with novelty, and richly neurologically rewarding. I then take a brisk morning walk in which I vary my path for the sake of novelty (pumping norepinephrine), pay close attention to my surroundings (pumping acetylcholine and serotonin), and delight in all of the wonderful things out there in my world (pumping dopamine). My dog Doug enjoys this process of waking up brain and body almost as much as I do! Of course, there are a thousand other stimulating things that could help you get your day off to a lively start.
If you anticipate feeling altered by a time change, you could also think about preparing for it in advance. If it’s the semi-annual 1-hour change that throws you off kilter, you might adjust your bedtime by 10 minutes a day for the week before. If you are traveling 12 time zones (and flipping night and day), you may need to make larger adjustments over the preceding couple of weeks. Generally, without that preparation, it takes about 1 day per time zone crossed to naturally adjust your circadian rhythms.
If you’re a little lazier, like me, you might also adjust to jet lag by not forgetting to take along your little bottle of melatonin tablets, to give your pineal gland a little help. Still, that pineal gland will work hard to tell you to take a nap every day – just when you’ll probably want to be wide awake.
And if, after reading this column, you find yourself still annoyed by the upcoming 1-hour time change, you might just look around at what’s happening out there in the world and decide that your troubles are very small by comparison, and that you should delight in the “extra” hour of sunshine each evening!
Dr. Merzenich is professor emeritus, department of neuroscience, at the University of California, San Francisco. He reported serving in various positions and speaking for Posit Science and Stronger Brain, and has also received funding from the National Institutes of Health. A version of this article first appeared on Medscape.com.
On March 13, most of the United States and Canada will advance the clock an hour to be on Daylight Saving Time. Most other countries in the Northern Hemisphere will do the same within a few weeks; and many countries across the Southern Hemisphere turn the clock back an hour around the same time. A friend of mine, who spent time on Capitol Hill, once told me that whether it’s adjusting to Daylight Saving Time (and losing an hour of sleep) or switching back to Standard Time (and picking up an hour), large numbers of Americans call their member of Congress every season to complain.
Why are so many of us annoyed by the semi-annual resetting of clocks? Those reasons also come into play when we change time zones as we travel, when we work on the night shift, or when we live at higher latitudes, where depressive symptoms from seasonal affective disorder (SAD) can plague us as the period of daylight progressively shortens in winter.
Our internal clock(s)
Each of us has a biological master clock keeping track of where we are in our 24-hour day, making ongoing time-of-day-appropriate physical and neurologic adjustments. We refer to those automatic adjustments as “circadian” rhythms – from the Latin, for “around a day” rhythms.
One of the most important regulated functions that is influenced by this time keeping is our sleep-wake cycle. Our brain’s hypothalamus has a kind of “master clock” that receives inputs directly from our eyes, which is how our brain sets our daily cycle period at about 24 hours.
This master clock turns on a tiny structure in our brains, called the pineal gland, to release more of a sleep-inducing chemical, called melatonin, about the same time every evening. The level of melatonin slowly increases to reach maximum deep sleep in the night, then slowly declines as you advance toward morning awakening. The shift from darkness to daylight in the morning, causing your initial morning awakening, releases the excitatory neuromodulator norepinephrine, which, with other chemicals, “turns on the lights” in your brain.
That works well most of the time – but no one told your brain that you were going to arbitrarily go to bed an hour earlier (or in the fall, later) on Circadian Rhythm Time!
We also obviously shift the time on the mechanical clock – requiring a reset of the brain’s master clock – when we travel across time zones or work the night shift. That type of desynchronization of our master clock from the mechanical clock puts our waking and sleeping behaviors out of sync with the production of brain chemicals that affect our alertness and mood. The result may be that you find yourself tired, but not sleepy, and often grumpy or even depressed. As an example, on average, people who work the night shift are just a little bit more anxious and depressed than people who get up to rise and shine with the sun every morning.
Seasonal affective disorder
An extreme example of this desynchronization of the master clock can manifest as SAD. SAD is a type of depression that’s related to seasonal transitions. The most commonly cited cases of SAD are for the fall-to-winter transition. In North America, its prevalence is significantly influenced by the distance of one’s place of residence from the equator – with about 12 times the impact in Alaska versus Florida. Of note, a weaker effect of latitude has been recorded in Europe, where more settled populations have had thousands of years to biologically and culturally adapt to their seasonal patterns.
What can we do about our clocks being messed with?
The most common treatment for SAD is light therapy, in which patients sit or work under artificial lights in an early-morning period, to try to advance the chemical signaling that controls sleeping and waking. Alas, light therapy doesn’t work for everyone.
Another approach, with or without the lights, is to engage in activities early in the day that produce brain chemicals to contribute to bright and cheerful waking. Those “raring-to-go” brain chemicals include norepinephrine (produced when you encounter novelty and are just having fun), acetylcholine (produced when you are carefully paying attention and are in a learning and remembering mode), serotonin (produced when you are feeling positive and just a little bit euphoric), and dopamine (produced when you feel happy and all is right with the world).
In fact, you would benefit from creating the habit of starting every day with activity that wakes up your brain. I begin my day with computerized brain exercises that are attentionally demanding, filled with novelty, and richly neurologically rewarding. I then take a brisk morning walk in which I vary my path for the sake of novelty (pumping norepinephrine), pay close attention to my surroundings (pumping acetylcholine and serotonin), and delight in all of the wonderful things out there in my world (pumping dopamine). My dog Doug enjoys this process of waking up brain and body almost as much as I do! Of course, there are a thousand other stimulating things that could help you get your day off to a lively start.
If you anticipate feeling altered by a time change, you could also think about preparing for it in advance. If it’s the semi-annual 1-hour change that throws you off kilter, you might adjust your bedtime by 10 minutes a day for the week before. If you are traveling 12 time zones (and flipping night and day), you may need to make larger adjustments over the preceding couple of weeks. Generally, without that preparation, it takes about 1 day per time zone crossed to naturally adjust your circadian rhythms.
If you’re a little lazier, like me, you might also adjust to jet lag by not forgetting to take along your little bottle of melatonin tablets, to give your pineal gland a little help. Still, that pineal gland will work hard to tell you to take a nap every day – just when you’ll probably want to be wide awake.
And if, after reading this column, you find yourself still annoyed by the upcoming 1-hour time change, you might just look around at what’s happening out there in the world and decide that your troubles are very small by comparison, and that you should delight in the “extra” hour of sunshine each evening!
Dr. Merzenich is professor emeritus, department of neuroscience, at the University of California, San Francisco. He reported serving in various positions and speaking for Posit Science and Stronger Brain, and has also received funding from the National Institutes of Health. A version of this article first appeared on Medscape.com.
On March 13, most of the United States and Canada will advance the clock an hour to be on Daylight Saving Time. Most other countries in the Northern Hemisphere will do the same within a few weeks; and many countries across the Southern Hemisphere turn the clock back an hour around the same time. A friend of mine, who spent time on Capitol Hill, once told me that whether it’s adjusting to Daylight Saving Time (and losing an hour of sleep) or switching back to Standard Time (and picking up an hour), large numbers of Americans call their member of Congress every season to complain.
Why are so many of us annoyed by the semi-annual resetting of clocks? Those reasons also come into play when we change time zones as we travel, when we work on the night shift, or when we live at higher latitudes, where depressive symptoms from seasonal affective disorder (SAD) can plague us as the period of daylight progressively shortens in winter.
Our internal clock(s)
Each of us has a biological master clock keeping track of where we are in our 24-hour day, making ongoing time-of-day-appropriate physical and neurologic adjustments. We refer to those automatic adjustments as “circadian” rhythms – from the Latin, for “around a day” rhythms.
One of the most important regulated functions that is influenced by this time keeping is our sleep-wake cycle. Our brain’s hypothalamus has a kind of “master clock” that receives inputs directly from our eyes, which is how our brain sets our daily cycle period at about 24 hours.
This master clock turns on a tiny structure in our brains, called the pineal gland, to release more of a sleep-inducing chemical, called melatonin, about the same time every evening. The level of melatonin slowly increases to reach maximum deep sleep in the night, then slowly declines as you advance toward morning awakening. The shift from darkness to daylight in the morning, causing your initial morning awakening, releases the excitatory neuromodulator norepinephrine, which, with other chemicals, “turns on the lights” in your brain.
That works well most of the time – but no one told your brain that you were going to arbitrarily go to bed an hour earlier (or in the fall, later) on Circadian Rhythm Time!
We also obviously shift the time on the mechanical clock – requiring a reset of the brain’s master clock – when we travel across time zones or work the night shift. That type of desynchronization of our master clock from the mechanical clock puts our waking and sleeping behaviors out of sync with the production of brain chemicals that affect our alertness and mood. The result may be that you find yourself tired, but not sleepy, and often grumpy or even depressed. As an example, on average, people who work the night shift are just a little bit more anxious and depressed than people who get up to rise and shine with the sun every morning.
Seasonal affective disorder
An extreme example of this desynchronization of the master clock can manifest as SAD. SAD is a type of depression that’s related to seasonal transitions. The most commonly cited cases of SAD are for the fall-to-winter transition. In North America, its prevalence is significantly influenced by the distance of one’s place of residence from the equator – with about 12 times the impact in Alaska versus Florida. Of note, a weaker effect of latitude has been recorded in Europe, where more settled populations have had thousands of years to biologically and culturally adapt to their seasonal patterns.
What can we do about our clocks being messed with?
The most common treatment for SAD is light therapy, in which patients sit or work under artificial lights in an early-morning period, to try to advance the chemical signaling that controls sleeping and waking. Alas, light therapy doesn’t work for everyone.
Another approach, with or without the lights, is to engage in activities early in the day that produce brain chemicals to contribute to bright and cheerful waking. Those “raring-to-go” brain chemicals include norepinephrine (produced when you encounter novelty and are just having fun), acetylcholine (produced when you are carefully paying attention and are in a learning and remembering mode), serotonin (produced when you are feeling positive and just a little bit euphoric), and dopamine (produced when you feel happy and all is right with the world).
In fact, you would benefit from creating the habit of starting every day with activity that wakes up your brain. I begin my day with computerized brain exercises that are attentionally demanding, filled with novelty, and richly neurologically rewarding. I then take a brisk morning walk in which I vary my path for the sake of novelty (pumping norepinephrine), pay close attention to my surroundings (pumping acetylcholine and serotonin), and delight in all of the wonderful things out there in my world (pumping dopamine). My dog Doug enjoys this process of waking up brain and body almost as much as I do! Of course, there are a thousand other stimulating things that could help you get your day off to a lively start.
If you anticipate feeling altered by a time change, you could also think about preparing for it in advance. If it’s the semi-annual 1-hour change that throws you off kilter, you might adjust your bedtime by 10 minutes a day for the week before. If you are traveling 12 time zones (and flipping night and day), you may need to make larger adjustments over the preceding couple of weeks. Generally, without that preparation, it takes about 1 day per time zone crossed to naturally adjust your circadian rhythms.
If you’re a little lazier, like me, you might also adjust to jet lag by not forgetting to take along your little bottle of melatonin tablets, to give your pineal gland a little help. Still, that pineal gland will work hard to tell you to take a nap every day – just when you’ll probably want to be wide awake.
And if, after reading this column, you find yourself still annoyed by the upcoming 1-hour time change, you might just look around at what’s happening out there in the world and decide that your troubles are very small by comparison, and that you should delight in the “extra” hour of sunshine each evening!
Dr. Merzenich is professor emeritus, department of neuroscience, at the University of California, San Francisco. He reported serving in various positions and speaking for Posit Science and Stronger Brain, and has also received funding from the National Institutes of Health. A version of this article first appeared on Medscape.com.
Childhood-onset insomnia persists into adolescence and adulthood
Childhood-onset insomnia is a chronic problem in 43% of children, based on 15-year follow-up data from approximately 500 individuals.
Difficulty initiating or maintaining sleep (DIMS) is the most frequently reported insomnia symptom in children and teens, but longitudinal data on the trajectory of insomnia symptoms from childhood into adulthood are limited, Julio Fernandez-Mendoza, PhD, of Penn State University, Hershey, and colleagues wrote.
Previous studies have shown varying results, notably on the effect of objective short sleep duration (OSSD), they said. The extent to which the effect of OSSD on insomnia trajectories, and whether OSSD affects the development of insomnia in the transition to adulthood remains uncertain.
In a study published in Pediatrics, the researchers reviewed data from 502 children who enrolled at age 5-12 years between 2000 and 2005. The participants underwent laboratory polysomnography visits at baseline; 421 had a second laboratory visit between 2010 and 2013 (median age, 16 years), and 502 completed a structured self-reported survey between 2018 and 2021 at a median age of 24 years. At the first visit, 118 children met criteria for insomnia, defined as parent reports of often/moderate or very often/severe DIMS and/or use of over-the-counter or prescription sleep medications for DIMS. At the second visit, 120 children met the definition for insomnia.
Among children with insomnia symptoms at baseline, 53.7% had persistence of insomnia symptoms in adolescence and 61.9% had symptoms in young adulthood; 46.3% and 38.1% remitted at these times.
Among children with insomnia symptoms at adolescence, 57.5% and 42.5% had persistence and remittance, respectively, in young adulthood.
In children with insomnia at baseline, therefore, the most frequent developmental trajectory was persistence (43.3%) followed by remission (26.9% since childhood and 11.2% since adolescence) and a waxing and waning pattern (18.6%), the researchers said.
Among children with normal sleep at baseline, 69.7% retained normal sleep patterns in adolescence and 63.3% retained normal sleep in young adulthood; 30.3% and 36.7% developed insomnia in adolescence and young adulthood, respectively.
Overall, adult insomnia was reported by 22.0% and 20.8% of individuals with childhood and adolescent insomnia, respectively. In a multivariate analysis, the odds of adult insomnia were 2.6 times and 5.5 times higher among those with histories of short-sleeping in childhood and adolescence, respectively.
“The most common developmental trajectory for insomnia symptoms was that of persistence from childhood through young adulthood,” the researchers wrote in their discussion of the study.
“These 15-year longitudinal findings across three developmental stages indicate that insomnia symptoms should not be expected to developmentally remit in at least 40% of children and that adolescence is a critical developmental period for the adverse prognosis of the insomnia with short sleep duration phenotype,” they emphasized.
The study findings were limited by several factors including the collection of OSSD and other sleep data via a 1-night, 9-hour polysomnography, which might not be representative of habitual sleep at home, the researchers noted. Other limitations include the lack of polysomnography data to accompany the young adult survey and the inability to validate insomnia in young adults via strict diagnostic criteria.
However, the results reveal that the persistence of childhood insomnia is higher than suggested in previous studies, and that these children and adolescents, especially short sleepers, are at significantly increased risk of adult insomnia, the researchers concluded.
“Early sleep interventions are a priority, as clinicians should not expect insomnia symptoms to developmentally remit in a high proportion of children, although objective sleep measures may be indicated in adolescence to identify those with poorer long-term prognosis,” they said.
Pandemic prompts interest in sleep issues
The current study is important at this time because sleep disruptions in children and adolescents have increased over the course of the COVID-19 pandemic, Karalyn Kinsella, MD, a pediatrician in private practice in Cheshire, Conn., said in an interview.
Dr. Kinsella said she was especially surprised to see that adolescent insomnia will most likely not remit in young adulthood, as she had considered it a disorder of adolescence.
The study highlights the need for early intervention to manage insomnia in children. However, there are several barriers to such intervention. “Parents [of young children] are overwhelmed and just need sleep themselves, so they don’t always have the energy to work on good sleep habits in their children,” she said. Improving sleep habits in adolescents requires overcoming the barrier of the young patients’ attitudes. “For adolescents, they need to buy into the change.”
However, the take-home message for clinicians is that it is important to work to overcome these barriers and improve sleep in children and teens, because the longitudinal data suggest that the problem is “likely to persist and unlikely to remit,” for many, she said.
As for additional studies, “I would like to see more research done on neurologic and psychological causes of insomnia,” Dr. Kinsella said.
The study was supported in part by grants from the National Heart, Lung, and Blood Institute; National Institute of Mental Health; and the National Center for Advancing Translational Sciences of the National Institutes of Health. The researchers had no financial conflicts to disclose. Dr. Kinsella had no financial conflicts to disclose and serves on the editorial advisory board of Pediatric News.
Childhood-onset insomnia is a chronic problem in 43% of children, based on 15-year follow-up data from approximately 500 individuals.
Difficulty initiating or maintaining sleep (DIMS) is the most frequently reported insomnia symptom in children and teens, but longitudinal data on the trajectory of insomnia symptoms from childhood into adulthood are limited, Julio Fernandez-Mendoza, PhD, of Penn State University, Hershey, and colleagues wrote.
Previous studies have shown varying results, notably on the effect of objective short sleep duration (OSSD), they said. The extent to which the effect of OSSD on insomnia trajectories, and whether OSSD affects the development of insomnia in the transition to adulthood remains uncertain.
In a study published in Pediatrics, the researchers reviewed data from 502 children who enrolled at age 5-12 years between 2000 and 2005. The participants underwent laboratory polysomnography visits at baseline; 421 had a second laboratory visit between 2010 and 2013 (median age, 16 years), and 502 completed a structured self-reported survey between 2018 and 2021 at a median age of 24 years. At the first visit, 118 children met criteria for insomnia, defined as parent reports of often/moderate or very often/severe DIMS and/or use of over-the-counter or prescription sleep medications for DIMS. At the second visit, 120 children met the definition for insomnia.
Among children with insomnia symptoms at baseline, 53.7% had persistence of insomnia symptoms in adolescence and 61.9% had symptoms in young adulthood; 46.3% and 38.1% remitted at these times.
Among children with insomnia symptoms at adolescence, 57.5% and 42.5% had persistence and remittance, respectively, in young adulthood.
In children with insomnia at baseline, therefore, the most frequent developmental trajectory was persistence (43.3%) followed by remission (26.9% since childhood and 11.2% since adolescence) and a waxing and waning pattern (18.6%), the researchers said.
Among children with normal sleep at baseline, 69.7% retained normal sleep patterns in adolescence and 63.3% retained normal sleep in young adulthood; 30.3% and 36.7% developed insomnia in adolescence and young adulthood, respectively.
Overall, adult insomnia was reported by 22.0% and 20.8% of individuals with childhood and adolescent insomnia, respectively. In a multivariate analysis, the odds of adult insomnia were 2.6 times and 5.5 times higher among those with histories of short-sleeping in childhood and adolescence, respectively.
“The most common developmental trajectory for insomnia symptoms was that of persistence from childhood through young adulthood,” the researchers wrote in their discussion of the study.
“These 15-year longitudinal findings across three developmental stages indicate that insomnia symptoms should not be expected to developmentally remit in at least 40% of children and that adolescence is a critical developmental period for the adverse prognosis of the insomnia with short sleep duration phenotype,” they emphasized.
The study findings were limited by several factors including the collection of OSSD and other sleep data via a 1-night, 9-hour polysomnography, which might not be representative of habitual sleep at home, the researchers noted. Other limitations include the lack of polysomnography data to accompany the young adult survey and the inability to validate insomnia in young adults via strict diagnostic criteria.
However, the results reveal that the persistence of childhood insomnia is higher than suggested in previous studies, and that these children and adolescents, especially short sleepers, are at significantly increased risk of adult insomnia, the researchers concluded.
“Early sleep interventions are a priority, as clinicians should not expect insomnia symptoms to developmentally remit in a high proportion of children, although objective sleep measures may be indicated in adolescence to identify those with poorer long-term prognosis,” they said.
Pandemic prompts interest in sleep issues
The current study is important at this time because sleep disruptions in children and adolescents have increased over the course of the COVID-19 pandemic, Karalyn Kinsella, MD, a pediatrician in private practice in Cheshire, Conn., said in an interview.
Dr. Kinsella said she was especially surprised to see that adolescent insomnia will most likely not remit in young adulthood, as she had considered it a disorder of adolescence.
The study highlights the need for early intervention to manage insomnia in children. However, there are several barriers to such intervention. “Parents [of young children] are overwhelmed and just need sleep themselves, so they don’t always have the energy to work on good sleep habits in their children,” she said. Improving sleep habits in adolescents requires overcoming the barrier of the young patients’ attitudes. “For adolescents, they need to buy into the change.”
However, the take-home message for clinicians is that it is important to work to overcome these barriers and improve sleep in children and teens, because the longitudinal data suggest that the problem is “likely to persist and unlikely to remit,” for many, she said.
As for additional studies, “I would like to see more research done on neurologic and psychological causes of insomnia,” Dr. Kinsella said.
The study was supported in part by grants from the National Heart, Lung, and Blood Institute; National Institute of Mental Health; and the National Center for Advancing Translational Sciences of the National Institutes of Health. The researchers had no financial conflicts to disclose. Dr. Kinsella had no financial conflicts to disclose and serves on the editorial advisory board of Pediatric News.
Childhood-onset insomnia is a chronic problem in 43% of children, based on 15-year follow-up data from approximately 500 individuals.
Difficulty initiating or maintaining sleep (DIMS) is the most frequently reported insomnia symptom in children and teens, but longitudinal data on the trajectory of insomnia symptoms from childhood into adulthood are limited, Julio Fernandez-Mendoza, PhD, of Penn State University, Hershey, and colleagues wrote.
Previous studies have shown varying results, notably on the effect of objective short sleep duration (OSSD), they said. The extent to which the effect of OSSD on insomnia trajectories, and whether OSSD affects the development of insomnia in the transition to adulthood remains uncertain.
In a study published in Pediatrics, the researchers reviewed data from 502 children who enrolled at age 5-12 years between 2000 and 2005. The participants underwent laboratory polysomnography visits at baseline; 421 had a second laboratory visit between 2010 and 2013 (median age, 16 years), and 502 completed a structured self-reported survey between 2018 and 2021 at a median age of 24 years. At the first visit, 118 children met criteria for insomnia, defined as parent reports of often/moderate or very often/severe DIMS and/or use of over-the-counter or prescription sleep medications for DIMS. At the second visit, 120 children met the definition for insomnia.
Among children with insomnia symptoms at baseline, 53.7% had persistence of insomnia symptoms in adolescence and 61.9% had symptoms in young adulthood; 46.3% and 38.1% remitted at these times.
Among children with insomnia symptoms at adolescence, 57.5% and 42.5% had persistence and remittance, respectively, in young adulthood.
In children with insomnia at baseline, therefore, the most frequent developmental trajectory was persistence (43.3%) followed by remission (26.9% since childhood and 11.2% since adolescence) and a waxing and waning pattern (18.6%), the researchers said.
Among children with normal sleep at baseline, 69.7% retained normal sleep patterns in adolescence and 63.3% retained normal sleep in young adulthood; 30.3% and 36.7% developed insomnia in adolescence and young adulthood, respectively.
Overall, adult insomnia was reported by 22.0% and 20.8% of individuals with childhood and adolescent insomnia, respectively. In a multivariate analysis, the odds of adult insomnia were 2.6 times and 5.5 times higher among those with histories of short-sleeping in childhood and adolescence, respectively.
“The most common developmental trajectory for insomnia symptoms was that of persistence from childhood through young adulthood,” the researchers wrote in their discussion of the study.
“These 15-year longitudinal findings across three developmental stages indicate that insomnia symptoms should not be expected to developmentally remit in at least 40% of children and that adolescence is a critical developmental period for the adverse prognosis of the insomnia with short sleep duration phenotype,” they emphasized.
The study findings were limited by several factors including the collection of OSSD and other sleep data via a 1-night, 9-hour polysomnography, which might not be representative of habitual sleep at home, the researchers noted. Other limitations include the lack of polysomnography data to accompany the young adult survey and the inability to validate insomnia in young adults via strict diagnostic criteria.
However, the results reveal that the persistence of childhood insomnia is higher than suggested in previous studies, and that these children and adolescents, especially short sleepers, are at significantly increased risk of adult insomnia, the researchers concluded.
“Early sleep interventions are a priority, as clinicians should not expect insomnia symptoms to developmentally remit in a high proportion of children, although objective sleep measures may be indicated in adolescence to identify those with poorer long-term prognosis,” they said.
Pandemic prompts interest in sleep issues
The current study is important at this time because sleep disruptions in children and adolescents have increased over the course of the COVID-19 pandemic, Karalyn Kinsella, MD, a pediatrician in private practice in Cheshire, Conn., said in an interview.
Dr. Kinsella said she was especially surprised to see that adolescent insomnia will most likely not remit in young adulthood, as she had considered it a disorder of adolescence.
The study highlights the need for early intervention to manage insomnia in children. However, there are several barriers to such intervention. “Parents [of young children] are overwhelmed and just need sleep themselves, so they don’t always have the energy to work on good sleep habits in their children,” she said. Improving sleep habits in adolescents requires overcoming the barrier of the young patients’ attitudes. “For adolescents, they need to buy into the change.”
However, the take-home message for clinicians is that it is important to work to overcome these barriers and improve sleep in children and teens, because the longitudinal data suggest that the problem is “likely to persist and unlikely to remit,” for many, she said.
As for additional studies, “I would like to see more research done on neurologic and psychological causes of insomnia,” Dr. Kinsella said.
The study was supported in part by grants from the National Heart, Lung, and Blood Institute; National Institute of Mental Health; and the National Center for Advancing Translational Sciences of the National Institutes of Health. The researchers had no financial conflicts to disclose. Dr. Kinsella had no financial conflicts to disclose and serves on the editorial advisory board of Pediatric News.
FROM PEDIATRICS
Restless legs syndrome surged early during pandemic
according to data from 500 participants in the National Restless Legs Syndrome Opioid Registry.
Sufferers of restless legs syndrome (RLS) experience not only sleep disturbance, but also daytime sleepiness, and high levels of depression, anxiety, and panic, wrote Benjamin Wipper of Harvard Medical School, Boston, and colleagues.
“Considering the link between RLS and psychiatric illness, it has been speculated that there may have been increases in RLS symptom severity alongside the recent rise in depression and anxiety,” but this association has not been explored, they said.
In a study published in Sleep Medicine , the researchers reviewed data from 500 adult participants in the National RLS Opioid Registry, a longitudinal observational study. Participants reported RLS symptom severity before and during the COVID-19 pandemic at 6-month intervals. Survey responses were collected from the early phase of the pandemic in the United States in January/February 2020, then in April/May 2020, and then 6 months later, from September 2020 through February 2021, and also 1 year later, in March 2021 through June 2021.
Participants completed a baseline phone interview and online survey, with symptoms assessed via the International Restless Legs Syndrome Study Group severity scale (IRLS), the Insomnia Severity Index (ISI), the General Anxiety Disorder-7 scale (GAD-7), and the Patient Health Questionnaire (PHQ-9).
In all, 153 participants completed surveys during January and February 2020, and 155 completed surveys during April and May 2020. Baseline characteristics were similar for all participants.
In a between-subjects analysis for these time periods, symptom scores on the IRLS were significantly higher in January/February 2020; participants were approximately twice as likely to have IRLS scores of 20 or higher compared to April/May 2020 (37.7% vs. 20.9%).
The researchers also compared responses by the same participants at baseline and 6 months later, from September 2020 through February 2021, and 1 year later, from March 2021 through June 2021. In this within-subjects analysis, 51.3% of the participants had increased IRLS scores in spring 2020. Participants were significantly more likely to have IRLS scores of 20 or above in the early COVID-19 period in April and May 2020 compared with baseline (37.7% vs. 26.6%). Both PHQ-9 and GAD-7 scores were higher during early COVID-19 in April and May 2020 than at baseline.
“Changes in IRLS were also significantly correlated with changes in both PHQ-9 and GAD-7 scores, providing further support for the associations of RLS to both depression and anxiety,” the researchers wrote. “Notably, individuals who completed surveys in January and February 2020 did not see increases in RLS severity or other mental health questionnaire values on subsequent six-month surveys completed during the pandemic or on the following iteration of surveys 1 year later. We suspect that these findings may be at least partially related to the timing of the surveys,” the researchers said. Six-month survey data for most patients were collected during a decline in cases and hospitalizations, and 1-year data in early 2021 may have reflected optimism with the availability of vaccines, they said.
The study findings were limited by several factors including the observational design, which prevented conclusions about causality, and the lack of data on the effect of COVID-19 infection on RLS symptoms, which should be investigated in future studies, the researchers said.
However, the results are the first evidence of increased RLS symptom severity during the COVID-19 pandemic, and elevated scores were associated with sleep disturbance, depression, and anxiety, they wrote. “These data suggest that clinicians should attend to RLS symptoms during the current pandemic and in future instances of socioeconomic and/or political uncertainty. Future studies need to confirm these findings in other populations of patients with RLS,” they concluded.
The National RLS Opioid Registry has received research funding from the RLS Foundation, the Baszucki Brain Research Fund, Florence Petrlik Family Foundation, Diane and Richard Brainerd, Steven Silin, and Jerry Blakeley. The researchers had no financial conflicts to disclose.
according to data from 500 participants in the National Restless Legs Syndrome Opioid Registry.
Sufferers of restless legs syndrome (RLS) experience not only sleep disturbance, but also daytime sleepiness, and high levels of depression, anxiety, and panic, wrote Benjamin Wipper of Harvard Medical School, Boston, and colleagues.
“Considering the link between RLS and psychiatric illness, it has been speculated that there may have been increases in RLS symptom severity alongside the recent rise in depression and anxiety,” but this association has not been explored, they said.
In a study published in Sleep Medicine , the researchers reviewed data from 500 adult participants in the National RLS Opioid Registry, a longitudinal observational study. Participants reported RLS symptom severity before and during the COVID-19 pandemic at 6-month intervals. Survey responses were collected from the early phase of the pandemic in the United States in January/February 2020, then in April/May 2020, and then 6 months later, from September 2020 through February 2021, and also 1 year later, in March 2021 through June 2021.
Participants completed a baseline phone interview and online survey, with symptoms assessed via the International Restless Legs Syndrome Study Group severity scale (IRLS), the Insomnia Severity Index (ISI), the General Anxiety Disorder-7 scale (GAD-7), and the Patient Health Questionnaire (PHQ-9).
In all, 153 participants completed surveys during January and February 2020, and 155 completed surveys during April and May 2020. Baseline characteristics were similar for all participants.
In a between-subjects analysis for these time periods, symptom scores on the IRLS were significantly higher in January/February 2020; participants were approximately twice as likely to have IRLS scores of 20 or higher compared to April/May 2020 (37.7% vs. 20.9%).
The researchers also compared responses by the same participants at baseline and 6 months later, from September 2020 through February 2021, and 1 year later, from March 2021 through June 2021. In this within-subjects analysis, 51.3% of the participants had increased IRLS scores in spring 2020. Participants were significantly more likely to have IRLS scores of 20 or above in the early COVID-19 period in April and May 2020 compared with baseline (37.7% vs. 26.6%). Both PHQ-9 and GAD-7 scores were higher during early COVID-19 in April and May 2020 than at baseline.
“Changes in IRLS were also significantly correlated with changes in both PHQ-9 and GAD-7 scores, providing further support for the associations of RLS to both depression and anxiety,” the researchers wrote. “Notably, individuals who completed surveys in January and February 2020 did not see increases in RLS severity or other mental health questionnaire values on subsequent six-month surveys completed during the pandemic or on the following iteration of surveys 1 year later. We suspect that these findings may be at least partially related to the timing of the surveys,” the researchers said. Six-month survey data for most patients were collected during a decline in cases and hospitalizations, and 1-year data in early 2021 may have reflected optimism with the availability of vaccines, they said.
The study findings were limited by several factors including the observational design, which prevented conclusions about causality, and the lack of data on the effect of COVID-19 infection on RLS symptoms, which should be investigated in future studies, the researchers said.
However, the results are the first evidence of increased RLS symptom severity during the COVID-19 pandemic, and elevated scores were associated with sleep disturbance, depression, and anxiety, they wrote. “These data suggest that clinicians should attend to RLS symptoms during the current pandemic and in future instances of socioeconomic and/or political uncertainty. Future studies need to confirm these findings in other populations of patients with RLS,” they concluded.
The National RLS Opioid Registry has received research funding from the RLS Foundation, the Baszucki Brain Research Fund, Florence Petrlik Family Foundation, Diane and Richard Brainerd, Steven Silin, and Jerry Blakeley. The researchers had no financial conflicts to disclose.
according to data from 500 participants in the National Restless Legs Syndrome Opioid Registry.
Sufferers of restless legs syndrome (RLS) experience not only sleep disturbance, but also daytime sleepiness, and high levels of depression, anxiety, and panic, wrote Benjamin Wipper of Harvard Medical School, Boston, and colleagues.
“Considering the link between RLS and psychiatric illness, it has been speculated that there may have been increases in RLS symptom severity alongside the recent rise in depression and anxiety,” but this association has not been explored, they said.
In a study published in Sleep Medicine , the researchers reviewed data from 500 adult participants in the National RLS Opioid Registry, a longitudinal observational study. Participants reported RLS symptom severity before and during the COVID-19 pandemic at 6-month intervals. Survey responses were collected from the early phase of the pandemic in the United States in January/February 2020, then in April/May 2020, and then 6 months later, from September 2020 through February 2021, and also 1 year later, in March 2021 through June 2021.
Participants completed a baseline phone interview and online survey, with symptoms assessed via the International Restless Legs Syndrome Study Group severity scale (IRLS), the Insomnia Severity Index (ISI), the General Anxiety Disorder-7 scale (GAD-7), and the Patient Health Questionnaire (PHQ-9).
In all, 153 participants completed surveys during January and February 2020, and 155 completed surveys during April and May 2020. Baseline characteristics were similar for all participants.
In a between-subjects analysis for these time periods, symptom scores on the IRLS were significantly higher in January/February 2020; participants were approximately twice as likely to have IRLS scores of 20 or higher compared to April/May 2020 (37.7% vs. 20.9%).
The researchers also compared responses by the same participants at baseline and 6 months later, from September 2020 through February 2021, and 1 year later, from March 2021 through June 2021. In this within-subjects analysis, 51.3% of the participants had increased IRLS scores in spring 2020. Participants were significantly more likely to have IRLS scores of 20 or above in the early COVID-19 period in April and May 2020 compared with baseline (37.7% vs. 26.6%). Both PHQ-9 and GAD-7 scores were higher during early COVID-19 in April and May 2020 than at baseline.
“Changes in IRLS were also significantly correlated with changes in both PHQ-9 and GAD-7 scores, providing further support for the associations of RLS to both depression and anxiety,” the researchers wrote. “Notably, individuals who completed surveys in January and February 2020 did not see increases in RLS severity or other mental health questionnaire values on subsequent six-month surveys completed during the pandemic or on the following iteration of surveys 1 year later. We suspect that these findings may be at least partially related to the timing of the surveys,” the researchers said. Six-month survey data for most patients were collected during a decline in cases and hospitalizations, and 1-year data in early 2021 may have reflected optimism with the availability of vaccines, they said.
The study findings were limited by several factors including the observational design, which prevented conclusions about causality, and the lack of data on the effect of COVID-19 infection on RLS symptoms, which should be investigated in future studies, the researchers said.
However, the results are the first evidence of increased RLS symptom severity during the COVID-19 pandemic, and elevated scores were associated with sleep disturbance, depression, and anxiety, they wrote. “These data suggest that clinicians should attend to RLS symptoms during the current pandemic and in future instances of socioeconomic and/or political uncertainty. Future studies need to confirm these findings in other populations of patients with RLS,” they concluded.
The National RLS Opioid Registry has received research funding from the RLS Foundation, the Baszucki Brain Research Fund, Florence Petrlik Family Foundation, Diane and Richard Brainerd, Steven Silin, and Jerry Blakeley. The researchers had no financial conflicts to disclose.
FROM SLEEP MEDICINE
OTC melatonin supplement use rises fivefold over 20 years
, a new study finds, although only 2% of a recent group of survey respondents said they had taken the sleep aid within the past month.
The findings, reported Feb. 1 in a research letter in the Journal of the American Medical Association, suggest that “millions of U.S. individuals are using melatonin,” study coauthor Naima Covassin, PhD, an associate consultant at Mayo Clinic in Rochester, Minn., told this news organization. “It is important to ask patients who report sleep problems whether they consume melatonin supplements, and these findings should certainly prompt more research in this area.”
The supplements boost the levels of melatonin, a hormone that is linked to the sleep-wake cycle. “Melatonin facilitates our ability to fall asleep at our bedtime by decreasing the natural early evening circadian arousal that helps keep us alert despite our having been awake since the morning,” said David N. Neubauer, MD, a sleep specialist at Johns Hopkins University, Baltimore. “It isn’t so much that melatonin is sedating, but rather that it turns off arousal.”
For the new study, researchers tracked data from the National Health and Nutrition Examination Survey from 1999-2000 to 2017-2018 and focused on respondents aged 20 and older (n = 55,021, mean age, 47.5, 52% women). As the researchers noted, response rates dipped mightily from a high of 84% in 2001-2002 to just 51.9% in 2017-2018.
The study found that the overall reported weighted prevalence of melatonin use grew from 0.4% (95% confidence interval, 0.2%-1.0%) in 1999-2000 to 2.1% (95% CI, 1.5%-2.9%) in 2017-2018 (linear P = .004). In 93.9% of cases of reported melatonin use, the surveyors confirmed it by checking for supplement bottles.
“These trends were similar in men and women and across age groups,” Dr. Covassin said. “We also found that use of more than 5 mg/day melatonin was not reported till 2005-2006, and it has been increasing since.”
Melatonin supplements are now available in tablets, capsules, gummies, powders, liquids, sprays, and other formulations. Users can even buy CBD-melatonin combos.
The survey doesn’t explore why the respondents used melatonin nor whether they thought it actually helped them. “The study was designed to evaluate the breadth of use of melatonin, rather than its effectiveness as a sleep aid,” Dr. Covassin said.
Dr. Neubauer, who wasn’t associated with the study, said the research seems valid. According to him, melatonin use has likely grown because of marketing and a higher number of products. He added that melatonin products are being manufactured at higher doses, although melatonin has a flat dose-response curve. “Higher doses typically do not have a greater effect,” he said.
According to Dr. Covassin, melatonin is generally considered to be safe, although side effects such as fatigue, dizziness, and headaches have been reported in clinical trials. “This is especially evident when high doses are administered,” Dr. Covassin said. “Other potentially more harmful consequences have also been noted. For instance, it has been found that acute administration of melatonin may decrease glucose tolerance, which may be especially problematic in patients with preexisting vulnerabilities such in those with diabetes. There are also very limited data on whether sustained use is safe in the long run.”
Moving forward, Dr. Covassin said, “we are interested in better understanding consumption of melatonin supplements across different populations as well as the impact of chronic use.”
The study authors are supported by grants from the National Natural Science Foundation of China, National Institutes of Health, Sleep Number Corporation (to Mayo Clinic), the Alice Sheets Marriott Professorship, and the Mayo Clinic Marie Ingalls Research Career Development Award.
Dr. Covassin and Dr. Neubauer have disclosed no relevant financial relationships. Study coauthor Virend K. Somers, MD, PhD, reports having served as a consultant for Respicardia, Baker Tilly, Bayer, and Jazz Pharmaceuticals and serving on the Sleep Number Research Advisory Board.
A version of this article first appeared on Medscape.com.
, a new study finds, although only 2% of a recent group of survey respondents said they had taken the sleep aid within the past month.
The findings, reported Feb. 1 in a research letter in the Journal of the American Medical Association, suggest that “millions of U.S. individuals are using melatonin,” study coauthor Naima Covassin, PhD, an associate consultant at Mayo Clinic in Rochester, Minn., told this news organization. “It is important to ask patients who report sleep problems whether they consume melatonin supplements, and these findings should certainly prompt more research in this area.”
The supplements boost the levels of melatonin, a hormone that is linked to the sleep-wake cycle. “Melatonin facilitates our ability to fall asleep at our bedtime by decreasing the natural early evening circadian arousal that helps keep us alert despite our having been awake since the morning,” said David N. Neubauer, MD, a sleep specialist at Johns Hopkins University, Baltimore. “It isn’t so much that melatonin is sedating, but rather that it turns off arousal.”
For the new study, researchers tracked data from the National Health and Nutrition Examination Survey from 1999-2000 to 2017-2018 and focused on respondents aged 20 and older (n = 55,021, mean age, 47.5, 52% women). As the researchers noted, response rates dipped mightily from a high of 84% in 2001-2002 to just 51.9% in 2017-2018.
The study found that the overall reported weighted prevalence of melatonin use grew from 0.4% (95% confidence interval, 0.2%-1.0%) in 1999-2000 to 2.1% (95% CI, 1.5%-2.9%) in 2017-2018 (linear P = .004). In 93.9% of cases of reported melatonin use, the surveyors confirmed it by checking for supplement bottles.
“These trends were similar in men and women and across age groups,” Dr. Covassin said. “We also found that use of more than 5 mg/day melatonin was not reported till 2005-2006, and it has been increasing since.”
Melatonin supplements are now available in tablets, capsules, gummies, powders, liquids, sprays, and other formulations. Users can even buy CBD-melatonin combos.
The survey doesn’t explore why the respondents used melatonin nor whether they thought it actually helped them. “The study was designed to evaluate the breadth of use of melatonin, rather than its effectiveness as a sleep aid,” Dr. Covassin said.
Dr. Neubauer, who wasn’t associated with the study, said the research seems valid. According to him, melatonin use has likely grown because of marketing and a higher number of products. He added that melatonin products are being manufactured at higher doses, although melatonin has a flat dose-response curve. “Higher doses typically do not have a greater effect,” he said.
According to Dr. Covassin, melatonin is generally considered to be safe, although side effects such as fatigue, dizziness, and headaches have been reported in clinical trials. “This is especially evident when high doses are administered,” Dr. Covassin said. “Other potentially more harmful consequences have also been noted. For instance, it has been found that acute administration of melatonin may decrease glucose tolerance, which may be especially problematic in patients with preexisting vulnerabilities such in those with diabetes. There are also very limited data on whether sustained use is safe in the long run.”
Moving forward, Dr. Covassin said, “we are interested in better understanding consumption of melatonin supplements across different populations as well as the impact of chronic use.”
The study authors are supported by grants from the National Natural Science Foundation of China, National Institutes of Health, Sleep Number Corporation (to Mayo Clinic), the Alice Sheets Marriott Professorship, and the Mayo Clinic Marie Ingalls Research Career Development Award.
Dr. Covassin and Dr. Neubauer have disclosed no relevant financial relationships. Study coauthor Virend K. Somers, MD, PhD, reports having served as a consultant for Respicardia, Baker Tilly, Bayer, and Jazz Pharmaceuticals and serving on the Sleep Number Research Advisory Board.
A version of this article first appeared on Medscape.com.
, a new study finds, although only 2% of a recent group of survey respondents said they had taken the sleep aid within the past month.
The findings, reported Feb. 1 in a research letter in the Journal of the American Medical Association, suggest that “millions of U.S. individuals are using melatonin,” study coauthor Naima Covassin, PhD, an associate consultant at Mayo Clinic in Rochester, Minn., told this news organization. “It is important to ask patients who report sleep problems whether they consume melatonin supplements, and these findings should certainly prompt more research in this area.”
The supplements boost the levels of melatonin, a hormone that is linked to the sleep-wake cycle. “Melatonin facilitates our ability to fall asleep at our bedtime by decreasing the natural early evening circadian arousal that helps keep us alert despite our having been awake since the morning,” said David N. Neubauer, MD, a sleep specialist at Johns Hopkins University, Baltimore. “It isn’t so much that melatonin is sedating, but rather that it turns off arousal.”
For the new study, researchers tracked data from the National Health and Nutrition Examination Survey from 1999-2000 to 2017-2018 and focused on respondents aged 20 and older (n = 55,021, mean age, 47.5, 52% women). As the researchers noted, response rates dipped mightily from a high of 84% in 2001-2002 to just 51.9% in 2017-2018.
The study found that the overall reported weighted prevalence of melatonin use grew from 0.4% (95% confidence interval, 0.2%-1.0%) in 1999-2000 to 2.1% (95% CI, 1.5%-2.9%) in 2017-2018 (linear P = .004). In 93.9% of cases of reported melatonin use, the surveyors confirmed it by checking for supplement bottles.
“These trends were similar in men and women and across age groups,” Dr. Covassin said. “We also found that use of more than 5 mg/day melatonin was not reported till 2005-2006, and it has been increasing since.”
Melatonin supplements are now available in tablets, capsules, gummies, powders, liquids, sprays, and other formulations. Users can even buy CBD-melatonin combos.
The survey doesn’t explore why the respondents used melatonin nor whether they thought it actually helped them. “The study was designed to evaluate the breadth of use of melatonin, rather than its effectiveness as a sleep aid,” Dr. Covassin said.
Dr. Neubauer, who wasn’t associated with the study, said the research seems valid. According to him, melatonin use has likely grown because of marketing and a higher number of products. He added that melatonin products are being manufactured at higher doses, although melatonin has a flat dose-response curve. “Higher doses typically do not have a greater effect,” he said.
According to Dr. Covassin, melatonin is generally considered to be safe, although side effects such as fatigue, dizziness, and headaches have been reported in clinical trials. “This is especially evident when high doses are administered,” Dr. Covassin said. “Other potentially more harmful consequences have also been noted. For instance, it has been found that acute administration of melatonin may decrease glucose tolerance, which may be especially problematic in patients with preexisting vulnerabilities such in those with diabetes. There are also very limited data on whether sustained use is safe in the long run.”
Moving forward, Dr. Covassin said, “we are interested in better understanding consumption of melatonin supplements across different populations as well as the impact of chronic use.”
The study authors are supported by grants from the National Natural Science Foundation of China, National Institutes of Health, Sleep Number Corporation (to Mayo Clinic), the Alice Sheets Marriott Professorship, and the Mayo Clinic Marie Ingalls Research Career Development Award.
Dr. Covassin and Dr. Neubauer have disclosed no relevant financial relationships. Study coauthor Virend K. Somers, MD, PhD, reports having served as a consultant for Respicardia, Baker Tilly, Bayer, and Jazz Pharmaceuticals and serving on the Sleep Number Research Advisory Board.
A version of this article first appeared on Medscape.com.
FROM JAMA
Newly approved drug improves sleep onset in insomnia
In the first of two studies, a 50-mg dose of daridorexant was associated with a reduction in latency to persistent sleep (LPS) of 11.7 minutes at month 3 versus placebo. The drug also was associated with improved daytime function.
Based on these results, the Food and Drug Administration approved daridorexant for the treatment of insomnia in adults earlier in January.
“The study shows that it is a really good drug that works differently from most other drugs,” said Emmanuel Mignot, MD, PhD, professor of sleep medicine at Stanford (Calif.) University. “It’s more specific to sleep,” Dr. Mignot added.
The findings were published in the February issue of The Lancet Neurology.
Two trials, three doses
Daridorexant is a dual orexin receptor antagonist intended to reduce excessive wakefulness. The investigators hypothesized that, because of its therapeutic target, the drug would not cause sleepiness on the morning after administration.
To examine daridorexant’s safety and efficacy, the researchers conducted two double-blind, parallel-group, phase 3 trials. Eligible participants were aged 18 years or older, had moderate to severe insomnia disorder, and had a self-reported history of disturbed sleep at least 3 nights per week for at least 3 months before screening.
In study 1, investigators randomly assigned participants in groups of equal size to daridorexant 25 mg, 50 mg, or placebo. In study 2, participants were randomly assigned to daridorexant 10 mg, 25 mg, or placebo.
During a placebo run-in period, participants underwent polysomnography on two consecutive nights to define baseline values. At the end of months 1 and 3 of the treatment period, participants again underwent 2 nights of polysomnography. A final night of polysomnography occurred during the placebo run-out period.
Self-assessments included the Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ). This questionnaire, to which participants responded daily, is designed to measure the daytime impairments related to insomnia. The IDSIQ questions focus on sleepiness, mood, alertness, and cognition.
The study’s primary endpoints were change from baseline in wake after sleep onset (WASO) and LPS at months 1 and 3. Secondary endpoints were change from baseline in self-reported total sleep time and change in the IDSIQ sleepiness domain score at months 1 and 3.
The investigators enrolled 930 participants in study 1 and 924 in study 2. In each study, more than two-thirds of participants were women, 39% were aged 65 or older, and demographic and baseline characteristics were similar between treatment groups.
Dose-dependent effects
At month 1 in study 1, WASO was reduced by 22.8 minutes (P < .0001) in patients who received the 50-mg dose and by 12.2 minutes (P < .0001) in the 25-mg dose. At month 3, WASO was reduced by 18.3 minutes (P < .0001) in those assigned to 50 mg and by 11.9 minutes (P < .0001) in those assigned to 25 mg.
LPS was reduced by 11.4 minutes (P < .0001) at month 1 and by 11.7 minutes (P < .0001) at month 3 with the 50-mg dose versus placebo. LPS was reduced by 8.3 minutes (P = .0005) at month 1 and by 7.6 minutes (P = .0015) at month 3 with the 25-mg dose versus placebo.
At both time points, self-reported total sleep time was significantly increased and the IDSIQ sleepiness score significantly improved with the 50-mg dose. The 25-mg dose was associated with significant improvements in self-reported total sleep time at both time points, but not with significant improvements in IDSIQ sleepiness score.
In study 2, the 25-mg dose was associated with significant reductions in WASO at month 1 (11.6 minutes, P = .0001) and month 3 (10.3 minutes, P = .0028) compared with placebo. The 25-mg dose was not associated with significant differences in LPS at either time point, however.
Similarly, the 25-mg dose was associated with improvements in self-reported total sleep time, but not with the IDSIQ sleepiness score. The 10-mg dose was not associated with improvements on any endpoint compared with placebo.
Longer studies needed
In an accompanying editorial, Kai Spiegelhalder, PhD, University of Freiburg, Germany, and colleagues pointed out that although insomnia disorder is defined by self-reported difficulty initiating or maintaining sleep, none of the primary or secondary endpoints in these trials addressed these symptoms.
However, Dr. Mignot noted the use of the IDSIQ scale is the most interesting aspect of the study. Although difficulty with concentration and mood impairment are major symptoms of insomnia, they are often neglected. “This drug was reversing the daytime impairment that insomniacs have,” said Dr. Mignot. “We now need to systematically study people not only for the effect on sleep, but also that it makes them feel better the day after.”
He added that most of the current hypnotics were not developed to treat insomnia. Daridorexant, in contrast, targets the wake-promoting orexin system. “It works more selectively on sleep and not on other things. Most of the other sleeping pills have more complex effects on the brain,” Dr. Mignot said.
Commenting on the study, John Winkelman, MD, PhD, professor of psychiatry at Harvard Medical School, Boston, said the low prevalence of side effects associated with daridorexant was remarkable. “This is not what most of the benzodiazepine receptor agonists looked like,” said Dr. Winkelman, who was not involved with the research.
Many insomnia drugs affect transmitter systems that are widespread in the brain, thus provoking side effects. But orexin-receptor antagonists “don’t seem to produce a lot of side effects,” he noted.
Although the study duration was reasonable, longer studies will be necessary, he added. “And it would be nice to see comparative data. Prescribers want to see some context.” said Dr. Winkelman.
The study was funded by Idorsia Pharmaceuticals. Dr. Mignot reported receiving research or clinical trial funding from Axsome, Jazz Pharmaceuticals, Avadel, Apple, Huami, Sunovion, and Takeda. He has also received consulting fees or speakers’ conference reimbursement from Idorsia, Centessa Pharmaceuticals, Jazz Pharmaceuticals, Avadel, Dreem, and Takeda. Dr. Winkelman has consulted for Idorsia and has participated in investigator-initiated studies supported by Merck.
A version of this article first appeared on Medscape.com.
In the first of two studies, a 50-mg dose of daridorexant was associated with a reduction in latency to persistent sleep (LPS) of 11.7 minutes at month 3 versus placebo. The drug also was associated with improved daytime function.
Based on these results, the Food and Drug Administration approved daridorexant for the treatment of insomnia in adults earlier in January.
“The study shows that it is a really good drug that works differently from most other drugs,” said Emmanuel Mignot, MD, PhD, professor of sleep medicine at Stanford (Calif.) University. “It’s more specific to sleep,” Dr. Mignot added.
The findings were published in the February issue of The Lancet Neurology.
Two trials, three doses
Daridorexant is a dual orexin receptor antagonist intended to reduce excessive wakefulness. The investigators hypothesized that, because of its therapeutic target, the drug would not cause sleepiness on the morning after administration.
To examine daridorexant’s safety and efficacy, the researchers conducted two double-blind, parallel-group, phase 3 trials. Eligible participants were aged 18 years or older, had moderate to severe insomnia disorder, and had a self-reported history of disturbed sleep at least 3 nights per week for at least 3 months before screening.
In study 1, investigators randomly assigned participants in groups of equal size to daridorexant 25 mg, 50 mg, or placebo. In study 2, participants were randomly assigned to daridorexant 10 mg, 25 mg, or placebo.
During a placebo run-in period, participants underwent polysomnography on two consecutive nights to define baseline values. At the end of months 1 and 3 of the treatment period, participants again underwent 2 nights of polysomnography. A final night of polysomnography occurred during the placebo run-out period.
Self-assessments included the Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ). This questionnaire, to which participants responded daily, is designed to measure the daytime impairments related to insomnia. The IDSIQ questions focus on sleepiness, mood, alertness, and cognition.
The study’s primary endpoints were change from baseline in wake after sleep onset (WASO) and LPS at months 1 and 3. Secondary endpoints were change from baseline in self-reported total sleep time and change in the IDSIQ sleepiness domain score at months 1 and 3.
The investigators enrolled 930 participants in study 1 and 924 in study 2. In each study, more than two-thirds of participants were women, 39% were aged 65 or older, and demographic and baseline characteristics were similar between treatment groups.
Dose-dependent effects
At month 1 in study 1, WASO was reduced by 22.8 minutes (P < .0001) in patients who received the 50-mg dose and by 12.2 minutes (P < .0001) in the 25-mg dose. At month 3, WASO was reduced by 18.3 minutes (P < .0001) in those assigned to 50 mg and by 11.9 minutes (P < .0001) in those assigned to 25 mg.
LPS was reduced by 11.4 minutes (P < .0001) at month 1 and by 11.7 minutes (P < .0001) at month 3 with the 50-mg dose versus placebo. LPS was reduced by 8.3 minutes (P = .0005) at month 1 and by 7.6 minutes (P = .0015) at month 3 with the 25-mg dose versus placebo.
At both time points, self-reported total sleep time was significantly increased and the IDSIQ sleepiness score significantly improved with the 50-mg dose. The 25-mg dose was associated with significant improvements in self-reported total sleep time at both time points, but not with significant improvements in IDSIQ sleepiness score.
In study 2, the 25-mg dose was associated with significant reductions in WASO at month 1 (11.6 minutes, P = .0001) and month 3 (10.3 minutes, P = .0028) compared with placebo. The 25-mg dose was not associated with significant differences in LPS at either time point, however.
Similarly, the 25-mg dose was associated with improvements in self-reported total sleep time, but not with the IDSIQ sleepiness score. The 10-mg dose was not associated with improvements on any endpoint compared with placebo.
Longer studies needed
In an accompanying editorial, Kai Spiegelhalder, PhD, University of Freiburg, Germany, and colleagues pointed out that although insomnia disorder is defined by self-reported difficulty initiating or maintaining sleep, none of the primary or secondary endpoints in these trials addressed these symptoms.
However, Dr. Mignot noted the use of the IDSIQ scale is the most interesting aspect of the study. Although difficulty with concentration and mood impairment are major symptoms of insomnia, they are often neglected. “This drug was reversing the daytime impairment that insomniacs have,” said Dr. Mignot. “We now need to systematically study people not only for the effect on sleep, but also that it makes them feel better the day after.”
He added that most of the current hypnotics were not developed to treat insomnia. Daridorexant, in contrast, targets the wake-promoting orexin system. “It works more selectively on sleep and not on other things. Most of the other sleeping pills have more complex effects on the brain,” Dr. Mignot said.
Commenting on the study, John Winkelman, MD, PhD, professor of psychiatry at Harvard Medical School, Boston, said the low prevalence of side effects associated with daridorexant was remarkable. “This is not what most of the benzodiazepine receptor agonists looked like,” said Dr. Winkelman, who was not involved with the research.
Many insomnia drugs affect transmitter systems that are widespread in the brain, thus provoking side effects. But orexin-receptor antagonists “don’t seem to produce a lot of side effects,” he noted.
Although the study duration was reasonable, longer studies will be necessary, he added. “And it would be nice to see comparative data. Prescribers want to see some context.” said Dr. Winkelman.
The study was funded by Idorsia Pharmaceuticals. Dr. Mignot reported receiving research or clinical trial funding from Axsome, Jazz Pharmaceuticals, Avadel, Apple, Huami, Sunovion, and Takeda. He has also received consulting fees or speakers’ conference reimbursement from Idorsia, Centessa Pharmaceuticals, Jazz Pharmaceuticals, Avadel, Dreem, and Takeda. Dr. Winkelman has consulted for Idorsia and has participated in investigator-initiated studies supported by Merck.
A version of this article first appeared on Medscape.com.
In the first of two studies, a 50-mg dose of daridorexant was associated with a reduction in latency to persistent sleep (LPS) of 11.7 minutes at month 3 versus placebo. The drug also was associated with improved daytime function.
Based on these results, the Food and Drug Administration approved daridorexant for the treatment of insomnia in adults earlier in January.
“The study shows that it is a really good drug that works differently from most other drugs,” said Emmanuel Mignot, MD, PhD, professor of sleep medicine at Stanford (Calif.) University. “It’s more specific to sleep,” Dr. Mignot added.
The findings were published in the February issue of The Lancet Neurology.
Two trials, three doses
Daridorexant is a dual orexin receptor antagonist intended to reduce excessive wakefulness. The investigators hypothesized that, because of its therapeutic target, the drug would not cause sleepiness on the morning after administration.
To examine daridorexant’s safety and efficacy, the researchers conducted two double-blind, parallel-group, phase 3 trials. Eligible participants were aged 18 years or older, had moderate to severe insomnia disorder, and had a self-reported history of disturbed sleep at least 3 nights per week for at least 3 months before screening.
In study 1, investigators randomly assigned participants in groups of equal size to daridorexant 25 mg, 50 mg, or placebo. In study 2, participants were randomly assigned to daridorexant 10 mg, 25 mg, or placebo.
During a placebo run-in period, participants underwent polysomnography on two consecutive nights to define baseline values. At the end of months 1 and 3 of the treatment period, participants again underwent 2 nights of polysomnography. A final night of polysomnography occurred during the placebo run-out period.
Self-assessments included the Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ). This questionnaire, to which participants responded daily, is designed to measure the daytime impairments related to insomnia. The IDSIQ questions focus on sleepiness, mood, alertness, and cognition.
The study’s primary endpoints were change from baseline in wake after sleep onset (WASO) and LPS at months 1 and 3. Secondary endpoints were change from baseline in self-reported total sleep time and change in the IDSIQ sleepiness domain score at months 1 and 3.
The investigators enrolled 930 participants in study 1 and 924 in study 2. In each study, more than two-thirds of participants were women, 39% were aged 65 or older, and demographic and baseline characteristics were similar between treatment groups.
Dose-dependent effects
At month 1 in study 1, WASO was reduced by 22.8 minutes (P < .0001) in patients who received the 50-mg dose and by 12.2 minutes (P < .0001) in the 25-mg dose. At month 3, WASO was reduced by 18.3 minutes (P < .0001) in those assigned to 50 mg and by 11.9 minutes (P < .0001) in those assigned to 25 mg.
LPS was reduced by 11.4 minutes (P < .0001) at month 1 and by 11.7 minutes (P < .0001) at month 3 with the 50-mg dose versus placebo. LPS was reduced by 8.3 minutes (P = .0005) at month 1 and by 7.6 minutes (P = .0015) at month 3 with the 25-mg dose versus placebo.
At both time points, self-reported total sleep time was significantly increased and the IDSIQ sleepiness score significantly improved with the 50-mg dose. The 25-mg dose was associated with significant improvements in self-reported total sleep time at both time points, but not with significant improvements in IDSIQ sleepiness score.
In study 2, the 25-mg dose was associated with significant reductions in WASO at month 1 (11.6 minutes, P = .0001) and month 3 (10.3 minutes, P = .0028) compared with placebo. The 25-mg dose was not associated with significant differences in LPS at either time point, however.
Similarly, the 25-mg dose was associated with improvements in self-reported total sleep time, but not with the IDSIQ sleepiness score. The 10-mg dose was not associated with improvements on any endpoint compared with placebo.
Longer studies needed
In an accompanying editorial, Kai Spiegelhalder, PhD, University of Freiburg, Germany, and colleagues pointed out that although insomnia disorder is defined by self-reported difficulty initiating or maintaining sleep, none of the primary or secondary endpoints in these trials addressed these symptoms.
However, Dr. Mignot noted the use of the IDSIQ scale is the most interesting aspect of the study. Although difficulty with concentration and mood impairment are major symptoms of insomnia, they are often neglected. “This drug was reversing the daytime impairment that insomniacs have,” said Dr. Mignot. “We now need to systematically study people not only for the effect on sleep, but also that it makes them feel better the day after.”
He added that most of the current hypnotics were not developed to treat insomnia. Daridorexant, in contrast, targets the wake-promoting orexin system. “It works more selectively on sleep and not on other things. Most of the other sleeping pills have more complex effects on the brain,” Dr. Mignot said.
Commenting on the study, John Winkelman, MD, PhD, professor of psychiatry at Harvard Medical School, Boston, said the low prevalence of side effects associated with daridorexant was remarkable. “This is not what most of the benzodiazepine receptor agonists looked like,” said Dr. Winkelman, who was not involved with the research.
Many insomnia drugs affect transmitter systems that are widespread in the brain, thus provoking side effects. But orexin-receptor antagonists “don’t seem to produce a lot of side effects,” he noted.
Although the study duration was reasonable, longer studies will be necessary, he added. “And it would be nice to see comparative data. Prescribers want to see some context.” said Dr. Winkelman.
The study was funded by Idorsia Pharmaceuticals. Dr. Mignot reported receiving research or clinical trial funding from Axsome, Jazz Pharmaceuticals, Avadel, Apple, Huami, Sunovion, and Takeda. He has also received consulting fees or speakers’ conference reimbursement from Idorsia, Centessa Pharmaceuticals, Jazz Pharmaceuticals, Avadel, Dreem, and Takeda. Dr. Winkelman has consulted for Idorsia and has participated in investigator-initiated studies supported by Merck.
A version of this article first appeared on Medscape.com.
FROM THE LANCET NEUROLOGY
OTC cannabidiol products tied to improved pain, sleep, anxiety
Interim findings from Advancing CBD Education and Science, a 100% virtual, open label, randomized, controlled trial, show study participants experienced various degrees of “clinically meaningful” improvements in sleep quality, anxiety, and pain.
“ACES is the largest clinical trial ever conducted on commercially available CBD products and provides first-of-its-kind real world evidence into what conditions users may experience benefit from CBD usage, whether these benefits are clinically meaningful, what attributes of CBD products may impact health outcomes, and what side effects may occur,” study coinvestigator Jessica Saleska, PhD, MPH, director of research at Radicle Science, the company that conducted the study, told this news organization.
Scant evidence
Despite the growing market size of commercially available CBD products “there is still scant data on the effectiveness of over-the-counter cannabinoid products due to the cost, speed, and scale limitations of the current approach to scientific research,” Jeff Chen, MD, MBA, cofounder and CEO of Radicle Science, told this news organization.
One of the study’s goals, said Ethan Russo, MD, a neurologist, founder/CEO of CReDO Science, and scientific adviser for Radicle, is to help consumers make informed decisions before purchasing and using commercially available oral CBD products.
Designed to eliminate all physical infrastructure, which minimizes costs and facilitates faster execution, ACES was conducted much like a phase 4 clinical trial, collating real-world data gathered over 4 weeks.
“The process that Radicle scientists [have] advanced is sort of a crowdsourcing approach to doing clinical science,” Dr. Russo said. “Hopefully, there is going to be a considerable amount of data generated that [will] affect people’s buying options.”
The study also aimed to evaluate product attributes, including composition, mode of use, dosage, dosage timing and frequency, and their correlation to degrees of outcomes.
Dr. Russo explained why product composition is an important factor, especially when dealing with CBD. “What happens with any given [CBD] preparation is going to be totally a function of other components, if any.
“For example, there’s this mistaken notion that cannabidiol is sedating; it is not. Pure cannabidiol is stimulating in low and moderate amounts. Where the confusion has arisen is that the early chemovars containing cannabidiol were also predominant in myrcene, the sedating terpene, [thereby] creating this misimpression that it is good for sleep,” he added.
However, CBD might also affect sleep by reducing anxiety that interferes with it. “What’s clear is that cannabidiol is an antianxiety agent, if you have a sufficient dose,” Dr. Russo said.
The 4-week study included 2,704 participants aged 21 years and older, self-reporting anxiety, chronic pain, or sleep disturbances as a primary reason for taking CBD. Study participants were randomly assigned to receive 1 of 13 commercially available oral CBD extracts.
Participants were allocated to 1 of 14 cohorts, comprising 13 treatment groups with 208 participants each who received a single CBD product, or a wait-list control group of 296 participants who received product at the study’s end.
The primary outcome focused on “clinically meaningful” changes, which were defined as “distinct and palpable improvements in quality of life through improvements in respective health outcomes.”
Secondary outcomes included changes in sleep, anxiety, and pain based on several validated indices, including the PROMIS (Patient-Reported Outcome Measurement Information System) Sleep Short Form; the PROMIS Anxiety Scale; the Patient Global Impression of Change; the Pain, Enjoyment, General Activity scale; and the General Anxiety Disorder–7 scale.
The interim study results are promising, with participants reporting, on average, a 71% improvement in well-being. Additionally, 63% reported clinically meaningful improvements in anxiety, and 61% in sleep quality. The CBD products provided smaller benefits in pain management, with less than half (47%) experiencing meaningful improvements.
In addition to improvement in sleep, pain, and anxiety, these data highlight how rapidly benefits occurred; most were realized during the first week of the study, with up to 61% of treatment group participants reporting a therapeutic effect within 1-4 hours of taking their assigned product.
Overcoming the placebo effect
Commenting on the research, Justin Strickland, PhD, an assistant professor of psychiatry and behavioral sciences at Johns Hopkins University, Baltimore, who was not involved in the research, said without knowing a lot about the pharmacology of the products being tested, early dramatic improvements in these measures, such as sleep impairment, are common.
“There are some data to suggest that there is an expectancy effect when we talk about the therapeutic benefit of cannabinoid products, (i.e., when someone has the expectation that they are going to experience a stronger effect) but this is true of any drug in an open label trial,” Dr. Strickland added.
Dr. Russo took the point a step further. “It’s getting near impossible to look at cannabinoid compounds, even with randomized, controlled trials because of the burgeoning placebo responses. When you couple it with the fact that consumers have the mistaken notion that cannabis-based drugs are miraculous, the expectations are so high that everyone thinks that they’re on the real stuff, even if it’s a placebo group.”
Still, both Dr. Strickland and Dr. Russo highlighted the fact that ACES mirrors real-world experience, which will they hope will inform the use of CBD and CBD-based preparations moving forward. By removing certain barriers like institutional bureaucracy or federal funding restrictions inherent to more traditional randomized controlled trial design, ACES might provide data that bridge the gap between efficacy and effectiveness.
ACES was funded by Radicle Science. Dr. Chen is cofounder and CEO of Radicle Science. Dr. Russo and Dr. Strickland disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Interim findings from Advancing CBD Education and Science, a 100% virtual, open label, randomized, controlled trial, show study participants experienced various degrees of “clinically meaningful” improvements in sleep quality, anxiety, and pain.
“ACES is the largest clinical trial ever conducted on commercially available CBD products and provides first-of-its-kind real world evidence into what conditions users may experience benefit from CBD usage, whether these benefits are clinically meaningful, what attributes of CBD products may impact health outcomes, and what side effects may occur,” study coinvestigator Jessica Saleska, PhD, MPH, director of research at Radicle Science, the company that conducted the study, told this news organization.
Scant evidence
Despite the growing market size of commercially available CBD products “there is still scant data on the effectiveness of over-the-counter cannabinoid products due to the cost, speed, and scale limitations of the current approach to scientific research,” Jeff Chen, MD, MBA, cofounder and CEO of Radicle Science, told this news organization.
One of the study’s goals, said Ethan Russo, MD, a neurologist, founder/CEO of CReDO Science, and scientific adviser for Radicle, is to help consumers make informed decisions before purchasing and using commercially available oral CBD products.
Designed to eliminate all physical infrastructure, which minimizes costs and facilitates faster execution, ACES was conducted much like a phase 4 clinical trial, collating real-world data gathered over 4 weeks.
“The process that Radicle scientists [have] advanced is sort of a crowdsourcing approach to doing clinical science,” Dr. Russo said. “Hopefully, there is going to be a considerable amount of data generated that [will] affect people’s buying options.”
The study also aimed to evaluate product attributes, including composition, mode of use, dosage, dosage timing and frequency, and their correlation to degrees of outcomes.
Dr. Russo explained why product composition is an important factor, especially when dealing with CBD. “What happens with any given [CBD] preparation is going to be totally a function of other components, if any.
“For example, there’s this mistaken notion that cannabidiol is sedating; it is not. Pure cannabidiol is stimulating in low and moderate amounts. Where the confusion has arisen is that the early chemovars containing cannabidiol were also predominant in myrcene, the sedating terpene, [thereby] creating this misimpression that it is good for sleep,” he added.
However, CBD might also affect sleep by reducing anxiety that interferes with it. “What’s clear is that cannabidiol is an antianxiety agent, if you have a sufficient dose,” Dr. Russo said.
The 4-week study included 2,704 participants aged 21 years and older, self-reporting anxiety, chronic pain, or sleep disturbances as a primary reason for taking CBD. Study participants were randomly assigned to receive 1 of 13 commercially available oral CBD extracts.
Participants were allocated to 1 of 14 cohorts, comprising 13 treatment groups with 208 participants each who received a single CBD product, or a wait-list control group of 296 participants who received product at the study’s end.
The primary outcome focused on “clinically meaningful” changes, which were defined as “distinct and palpable improvements in quality of life through improvements in respective health outcomes.”
Secondary outcomes included changes in sleep, anxiety, and pain based on several validated indices, including the PROMIS (Patient-Reported Outcome Measurement Information System) Sleep Short Form; the PROMIS Anxiety Scale; the Patient Global Impression of Change; the Pain, Enjoyment, General Activity scale; and the General Anxiety Disorder–7 scale.
The interim study results are promising, with participants reporting, on average, a 71% improvement in well-being. Additionally, 63% reported clinically meaningful improvements in anxiety, and 61% in sleep quality. The CBD products provided smaller benefits in pain management, with less than half (47%) experiencing meaningful improvements.
In addition to improvement in sleep, pain, and anxiety, these data highlight how rapidly benefits occurred; most were realized during the first week of the study, with up to 61% of treatment group participants reporting a therapeutic effect within 1-4 hours of taking their assigned product.
Overcoming the placebo effect
Commenting on the research, Justin Strickland, PhD, an assistant professor of psychiatry and behavioral sciences at Johns Hopkins University, Baltimore, who was not involved in the research, said without knowing a lot about the pharmacology of the products being tested, early dramatic improvements in these measures, such as sleep impairment, are common.
“There are some data to suggest that there is an expectancy effect when we talk about the therapeutic benefit of cannabinoid products, (i.e., when someone has the expectation that they are going to experience a stronger effect) but this is true of any drug in an open label trial,” Dr. Strickland added.
Dr. Russo took the point a step further. “It’s getting near impossible to look at cannabinoid compounds, even with randomized, controlled trials because of the burgeoning placebo responses. When you couple it with the fact that consumers have the mistaken notion that cannabis-based drugs are miraculous, the expectations are so high that everyone thinks that they’re on the real stuff, even if it’s a placebo group.”
Still, both Dr. Strickland and Dr. Russo highlighted the fact that ACES mirrors real-world experience, which will they hope will inform the use of CBD and CBD-based preparations moving forward. By removing certain barriers like institutional bureaucracy or federal funding restrictions inherent to more traditional randomized controlled trial design, ACES might provide data that bridge the gap between efficacy and effectiveness.
ACES was funded by Radicle Science. Dr. Chen is cofounder and CEO of Radicle Science. Dr. Russo and Dr. Strickland disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Interim findings from Advancing CBD Education and Science, a 100% virtual, open label, randomized, controlled trial, show study participants experienced various degrees of “clinically meaningful” improvements in sleep quality, anxiety, and pain.
“ACES is the largest clinical trial ever conducted on commercially available CBD products and provides first-of-its-kind real world evidence into what conditions users may experience benefit from CBD usage, whether these benefits are clinically meaningful, what attributes of CBD products may impact health outcomes, and what side effects may occur,” study coinvestigator Jessica Saleska, PhD, MPH, director of research at Radicle Science, the company that conducted the study, told this news organization.
Scant evidence
Despite the growing market size of commercially available CBD products “there is still scant data on the effectiveness of over-the-counter cannabinoid products due to the cost, speed, and scale limitations of the current approach to scientific research,” Jeff Chen, MD, MBA, cofounder and CEO of Radicle Science, told this news organization.
One of the study’s goals, said Ethan Russo, MD, a neurologist, founder/CEO of CReDO Science, and scientific adviser for Radicle, is to help consumers make informed decisions before purchasing and using commercially available oral CBD products.
Designed to eliminate all physical infrastructure, which minimizes costs and facilitates faster execution, ACES was conducted much like a phase 4 clinical trial, collating real-world data gathered over 4 weeks.
“The process that Radicle scientists [have] advanced is sort of a crowdsourcing approach to doing clinical science,” Dr. Russo said. “Hopefully, there is going to be a considerable amount of data generated that [will] affect people’s buying options.”
The study also aimed to evaluate product attributes, including composition, mode of use, dosage, dosage timing and frequency, and their correlation to degrees of outcomes.
Dr. Russo explained why product composition is an important factor, especially when dealing with CBD. “What happens with any given [CBD] preparation is going to be totally a function of other components, if any.
“For example, there’s this mistaken notion that cannabidiol is sedating; it is not. Pure cannabidiol is stimulating in low and moderate amounts. Where the confusion has arisen is that the early chemovars containing cannabidiol were also predominant in myrcene, the sedating terpene, [thereby] creating this misimpression that it is good for sleep,” he added.
However, CBD might also affect sleep by reducing anxiety that interferes with it. “What’s clear is that cannabidiol is an antianxiety agent, if you have a sufficient dose,” Dr. Russo said.
The 4-week study included 2,704 participants aged 21 years and older, self-reporting anxiety, chronic pain, or sleep disturbances as a primary reason for taking CBD. Study participants were randomly assigned to receive 1 of 13 commercially available oral CBD extracts.
Participants were allocated to 1 of 14 cohorts, comprising 13 treatment groups with 208 participants each who received a single CBD product, or a wait-list control group of 296 participants who received product at the study’s end.
The primary outcome focused on “clinically meaningful” changes, which were defined as “distinct and palpable improvements in quality of life through improvements in respective health outcomes.”
Secondary outcomes included changes in sleep, anxiety, and pain based on several validated indices, including the PROMIS (Patient-Reported Outcome Measurement Information System) Sleep Short Form; the PROMIS Anxiety Scale; the Patient Global Impression of Change; the Pain, Enjoyment, General Activity scale; and the General Anxiety Disorder–7 scale.
The interim study results are promising, with participants reporting, on average, a 71% improvement in well-being. Additionally, 63% reported clinically meaningful improvements in anxiety, and 61% in sleep quality. The CBD products provided smaller benefits in pain management, with less than half (47%) experiencing meaningful improvements.
In addition to improvement in sleep, pain, and anxiety, these data highlight how rapidly benefits occurred; most were realized during the first week of the study, with up to 61% of treatment group participants reporting a therapeutic effect within 1-4 hours of taking their assigned product.
Overcoming the placebo effect
Commenting on the research, Justin Strickland, PhD, an assistant professor of psychiatry and behavioral sciences at Johns Hopkins University, Baltimore, who was not involved in the research, said without knowing a lot about the pharmacology of the products being tested, early dramatic improvements in these measures, such as sleep impairment, are common.
“There are some data to suggest that there is an expectancy effect when we talk about the therapeutic benefit of cannabinoid products, (i.e., when someone has the expectation that they are going to experience a stronger effect) but this is true of any drug in an open label trial,” Dr. Strickland added.
Dr. Russo took the point a step further. “It’s getting near impossible to look at cannabinoid compounds, even with randomized, controlled trials because of the burgeoning placebo responses. When you couple it with the fact that consumers have the mistaken notion that cannabis-based drugs are miraculous, the expectations are so high that everyone thinks that they’re on the real stuff, even if it’s a placebo group.”
Still, both Dr. Strickland and Dr. Russo highlighted the fact that ACES mirrors real-world experience, which will they hope will inform the use of CBD and CBD-based preparations moving forward. By removing certain barriers like institutional bureaucracy or federal funding restrictions inherent to more traditional randomized controlled trial design, ACES might provide data that bridge the gap between efficacy and effectiveness.
ACES was funded by Radicle Science. Dr. Chen is cofounder and CEO of Radicle Science. Dr. Russo and Dr. Strickland disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Stabilizing circadian rhythm tied to lower suicide risk in bipolar disorder
Social rhythm therapy (SRT), which uses behavioral strategies to support healthy sleep and other routines, is linked to improved mood and reduced suicide risk in young people with bipolar disorder (BD), early research suggests.
The small study also showed SRT is both feasible and acceptable in this patient population.
Results showed SRT, which was primarily delivered via telehealth sessions, began to show efficacy approximately 6 weeks into the 12-week therapeutic program, the researchers noted.
“Improving the regularity of daily rhythms like sleep, physical activity, and social activities can be really robust in improving mental health and even reducing suicide risk,” study investigator Hilary P. Blumberg, MD, the John and Hope Furth Professor of Psychiatric Neuroscience and director of the mood disorders research program at Yale University, New Haven, Conn., said in an interview.
The findings are published in the American Journal of Psychotherapy.
Trigger for depression, mania
Previous research shows unstable circadian rhythms may trigger depressive and manic symptoms – and are risk factors for suicidal thoughts and behaviors. Although interpersonal and social rhythm therapy has shown promise in patients with mood disorders, there is little research focusing only on the social rhythm aspect of the therapy.
The researchers only examined SRT, modified to create a therapeutic program aimed at adolescents and young adults.
The study included 13 participants (mean age, 20.5 years) with BD and a score of 15 or more on the 29-item Hamilton Depression Rating Scale (HDRS-29) and/or a score of 12 or more on the Young Mania Rating Scale (YMRS).
Participants were enrolled in the National Institute of Mental Health Brain Emotion Circuitry Targeted Self-Monitoring and Regulation Therapy (BE-SMART) program, which requires MRI sessions at three in-person visits to assess brain changes with the therapy. All but one participant was taking mood-stabilizing medications.
“We didn’t ask them to come off medications because we didn’t want to exacerbate things,” said Dr. Blumberg. She added the therapeutic approach “could be adjunctive to further improve symptoms and reduce risk.”
The majority occurred on a secure video platform. Three were conducted in person.
Working with a therapist, participants were taught how to follow a daily routine. Dr. Blumberg noted this is not just a matter of going to sleep and getting up at the same time every day, but thoroughly reviewing details of all daily activities and routines, including who participants eat with and when, their exercise schedule, and social engagements.
Each week, participants completed the five-item version of the Social Rhythm Metric. At the end of the intervention, they also completed the Client Satisfaction Questionnaire (CSQ). Scores on the CSQ range from 8 to 32, with scores of 26-32 indicating “excellent” satisfaction.
In addition, participants and therapists completed the Working Alliance Inventory, which assesses the client-therapist relationship by asking about such things as degree of comfort and respect.
Before and after the intervention, participants reported the regularity of their social rhythms using the Brief Social Rhythm Scale (BSRS) and risk for suicidal behavior using a subscale of the Concise Health Risk Tracking (CHRT) scale.
High retention, ‘excellent satisfaction’
Results showed 10 of the 13 participants (9 females) completed all study procedures, for a retention rate of 77%. Treatment satisfaction was excellent (mean CSQ, 29.4).
Both therapists and participants had high scores on all aspects of the Working Alliance Inventory scale.
“High treatment retention, excellent client satisfaction, and strong working alliance scores support the feasibility and acceptability of this intervention for adolescents and young adults with bipolar disorder,” the investigators wrote.
Participants showed significant improvement in social rhythm regularity and reductions in depression and manic symptoms as well as suicide propensity (P = .016 for BSRS; .024 for HDRS-29; .028 for YMRS; and .028 for CHRT suicide propensity). Effect sizes were in the moderate to high range.
By the midpoint of the therapy, there were significant improvements in social rhythm regularity and suicide propensity and trend-level reductions in depression, suggesting the potential for early benefits.
Dr. Blumberg noted it is difficult to find a therapy that helps with both depressive and mania symptoms. “An antidepressant may reduce depression, but sometimes can worsen manic symptoms.”
Impact on emotional brain circuitry?
The association between improved regularity of social rhythms and reduced suicide propensity persisted even after controlling for mood symptom changes.
“Suicide risk was reduced not just because subjects were less depressed. There’s something about regularizing rhythms that can reduce suicide risk,” said Dr. Blumberg.
The reviewers noted that SRT administered remotely improves accessibility; and this intervention “is well suited to the future of psychotherapy delivery, which will undoubtedly include remote treatment delivery.”
The absence of a comparator condition was cited as a study limitation. The investigators noted the small sample size means the findings should be interpreted cautiously and verified in an adequately powered randomized controlled trial.
The researchers now have early results from the brain scanning component of the study. “Preliminary findings suggest the intervention seems to benefit emotional brain circuitry,” Dr. Blumberg said.
The researchers are about to embark on a new study funded by a grant from the American Foundation of Suicide Prevention. It will investigate SRT in preventing suicide in adolescents and adults to age 29 years with depression or BD.
In addition, the researchers have secured support from the Klingenstein Third Generation Foundation to research prevention in youth at risk for BD – and from Women’s Health Access Matters to examine the therapy in women 50 and older with depression, a population possibly at increased risk for dementia.
‘Promising’ results
Commenting on the findings, Michael Thase, MD, professor of psychiatry, University of Pennsylvania, and research psychiatrist at the Corporal Michael J. Crescenz Veterans Affairs Medical Center, both in Philadelphia, praised the study.
“It’s a very, very promising initial study because even though there’s no control group, it does show that participants liked the program, most finished it, and on average, people got quite a bit better,” said Dr. Thase, who was not involved with the research.
The treatment may be especially beneficial for young patients with bipolar disorder who, just by their very age, experience lifestyle disruptions, Dr. Thase noted. Results from a previous study of the therapeutic approach in adults showed “probably half of the adults didn’t take to it.”
However, not everyone in this new study benefited either, as some dropped out, which Dr. Thase noted is not atypical.
“No form of intervention is suitable for everyone,” he said.
The study was supported by grants from the National Institute of Mental Health, AIM Youth Mental Health Foundation, Klingenstein Third Generation Foundation, American Foundation for Suicide Prevention, International Bipolar Foundation, MQ Brighter Futures Program, For the Love of Travis Foundation, and the John and Hope Furth Endowment. Dr. Blumberg and Dr. Thase reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Social rhythm therapy (SRT), which uses behavioral strategies to support healthy sleep and other routines, is linked to improved mood and reduced suicide risk in young people with bipolar disorder (BD), early research suggests.
The small study also showed SRT is both feasible and acceptable in this patient population.
Results showed SRT, which was primarily delivered via telehealth sessions, began to show efficacy approximately 6 weeks into the 12-week therapeutic program, the researchers noted.
“Improving the regularity of daily rhythms like sleep, physical activity, and social activities can be really robust in improving mental health and even reducing suicide risk,” study investigator Hilary P. Blumberg, MD, the John and Hope Furth Professor of Psychiatric Neuroscience and director of the mood disorders research program at Yale University, New Haven, Conn., said in an interview.
The findings are published in the American Journal of Psychotherapy.
Trigger for depression, mania
Previous research shows unstable circadian rhythms may trigger depressive and manic symptoms – and are risk factors for suicidal thoughts and behaviors. Although interpersonal and social rhythm therapy has shown promise in patients with mood disorders, there is little research focusing only on the social rhythm aspect of the therapy.
The researchers only examined SRT, modified to create a therapeutic program aimed at adolescents and young adults.
The study included 13 participants (mean age, 20.5 years) with BD and a score of 15 or more on the 29-item Hamilton Depression Rating Scale (HDRS-29) and/or a score of 12 or more on the Young Mania Rating Scale (YMRS).
Participants were enrolled in the National Institute of Mental Health Brain Emotion Circuitry Targeted Self-Monitoring and Regulation Therapy (BE-SMART) program, which requires MRI sessions at three in-person visits to assess brain changes with the therapy. All but one participant was taking mood-stabilizing medications.
“We didn’t ask them to come off medications because we didn’t want to exacerbate things,” said Dr. Blumberg. She added the therapeutic approach “could be adjunctive to further improve symptoms and reduce risk.”
The majority occurred on a secure video platform. Three were conducted in person.
Working with a therapist, participants were taught how to follow a daily routine. Dr. Blumberg noted this is not just a matter of going to sleep and getting up at the same time every day, but thoroughly reviewing details of all daily activities and routines, including who participants eat with and when, their exercise schedule, and social engagements.
Each week, participants completed the five-item version of the Social Rhythm Metric. At the end of the intervention, they also completed the Client Satisfaction Questionnaire (CSQ). Scores on the CSQ range from 8 to 32, with scores of 26-32 indicating “excellent” satisfaction.
In addition, participants and therapists completed the Working Alliance Inventory, which assesses the client-therapist relationship by asking about such things as degree of comfort and respect.
Before and after the intervention, participants reported the regularity of their social rhythms using the Brief Social Rhythm Scale (BSRS) and risk for suicidal behavior using a subscale of the Concise Health Risk Tracking (CHRT) scale.
High retention, ‘excellent satisfaction’
Results showed 10 of the 13 participants (9 females) completed all study procedures, for a retention rate of 77%. Treatment satisfaction was excellent (mean CSQ, 29.4).
Both therapists and participants had high scores on all aspects of the Working Alliance Inventory scale.
“High treatment retention, excellent client satisfaction, and strong working alliance scores support the feasibility and acceptability of this intervention for adolescents and young adults with bipolar disorder,” the investigators wrote.
Participants showed significant improvement in social rhythm regularity and reductions in depression and manic symptoms as well as suicide propensity (P = .016 for BSRS; .024 for HDRS-29; .028 for YMRS; and .028 for CHRT suicide propensity). Effect sizes were in the moderate to high range.
By the midpoint of the therapy, there were significant improvements in social rhythm regularity and suicide propensity and trend-level reductions in depression, suggesting the potential for early benefits.
Dr. Blumberg noted it is difficult to find a therapy that helps with both depressive and mania symptoms. “An antidepressant may reduce depression, but sometimes can worsen manic symptoms.”
Impact on emotional brain circuitry?
The association between improved regularity of social rhythms and reduced suicide propensity persisted even after controlling for mood symptom changes.
“Suicide risk was reduced not just because subjects were less depressed. There’s something about regularizing rhythms that can reduce suicide risk,” said Dr. Blumberg.
The reviewers noted that SRT administered remotely improves accessibility; and this intervention “is well suited to the future of psychotherapy delivery, which will undoubtedly include remote treatment delivery.”
The absence of a comparator condition was cited as a study limitation. The investigators noted the small sample size means the findings should be interpreted cautiously and verified in an adequately powered randomized controlled trial.
The researchers now have early results from the brain scanning component of the study. “Preliminary findings suggest the intervention seems to benefit emotional brain circuitry,” Dr. Blumberg said.
The researchers are about to embark on a new study funded by a grant from the American Foundation of Suicide Prevention. It will investigate SRT in preventing suicide in adolescents and adults to age 29 years with depression or BD.
In addition, the researchers have secured support from the Klingenstein Third Generation Foundation to research prevention in youth at risk for BD – and from Women’s Health Access Matters to examine the therapy in women 50 and older with depression, a population possibly at increased risk for dementia.
‘Promising’ results
Commenting on the findings, Michael Thase, MD, professor of psychiatry, University of Pennsylvania, and research psychiatrist at the Corporal Michael J. Crescenz Veterans Affairs Medical Center, both in Philadelphia, praised the study.
“It’s a very, very promising initial study because even though there’s no control group, it does show that participants liked the program, most finished it, and on average, people got quite a bit better,” said Dr. Thase, who was not involved with the research.
The treatment may be especially beneficial for young patients with bipolar disorder who, just by their very age, experience lifestyle disruptions, Dr. Thase noted. Results from a previous study of the therapeutic approach in adults showed “probably half of the adults didn’t take to it.”
However, not everyone in this new study benefited either, as some dropped out, which Dr. Thase noted is not atypical.
“No form of intervention is suitable for everyone,” he said.
The study was supported by grants from the National Institute of Mental Health, AIM Youth Mental Health Foundation, Klingenstein Third Generation Foundation, American Foundation for Suicide Prevention, International Bipolar Foundation, MQ Brighter Futures Program, For the Love of Travis Foundation, and the John and Hope Furth Endowment. Dr. Blumberg and Dr. Thase reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Social rhythm therapy (SRT), which uses behavioral strategies to support healthy sleep and other routines, is linked to improved mood and reduced suicide risk in young people with bipolar disorder (BD), early research suggests.
The small study also showed SRT is both feasible and acceptable in this patient population.
Results showed SRT, which was primarily delivered via telehealth sessions, began to show efficacy approximately 6 weeks into the 12-week therapeutic program, the researchers noted.
“Improving the regularity of daily rhythms like sleep, physical activity, and social activities can be really robust in improving mental health and even reducing suicide risk,” study investigator Hilary P. Blumberg, MD, the John and Hope Furth Professor of Psychiatric Neuroscience and director of the mood disorders research program at Yale University, New Haven, Conn., said in an interview.
The findings are published in the American Journal of Psychotherapy.
Trigger for depression, mania
Previous research shows unstable circadian rhythms may trigger depressive and manic symptoms – and are risk factors for suicidal thoughts and behaviors. Although interpersonal and social rhythm therapy has shown promise in patients with mood disorders, there is little research focusing only on the social rhythm aspect of the therapy.
The researchers only examined SRT, modified to create a therapeutic program aimed at adolescents and young adults.
The study included 13 participants (mean age, 20.5 years) with BD and a score of 15 or more on the 29-item Hamilton Depression Rating Scale (HDRS-29) and/or a score of 12 or more on the Young Mania Rating Scale (YMRS).
Participants were enrolled in the National Institute of Mental Health Brain Emotion Circuitry Targeted Self-Monitoring and Regulation Therapy (BE-SMART) program, which requires MRI sessions at three in-person visits to assess brain changes with the therapy. All but one participant was taking mood-stabilizing medications.
“We didn’t ask them to come off medications because we didn’t want to exacerbate things,” said Dr. Blumberg. She added the therapeutic approach “could be adjunctive to further improve symptoms and reduce risk.”
The majority occurred on a secure video platform. Three were conducted in person.
Working with a therapist, participants were taught how to follow a daily routine. Dr. Blumberg noted this is not just a matter of going to sleep and getting up at the same time every day, but thoroughly reviewing details of all daily activities and routines, including who participants eat with and when, their exercise schedule, and social engagements.
Each week, participants completed the five-item version of the Social Rhythm Metric. At the end of the intervention, they also completed the Client Satisfaction Questionnaire (CSQ). Scores on the CSQ range from 8 to 32, with scores of 26-32 indicating “excellent” satisfaction.
In addition, participants and therapists completed the Working Alliance Inventory, which assesses the client-therapist relationship by asking about such things as degree of comfort and respect.
Before and after the intervention, participants reported the regularity of their social rhythms using the Brief Social Rhythm Scale (BSRS) and risk for suicidal behavior using a subscale of the Concise Health Risk Tracking (CHRT) scale.
High retention, ‘excellent satisfaction’
Results showed 10 of the 13 participants (9 females) completed all study procedures, for a retention rate of 77%. Treatment satisfaction was excellent (mean CSQ, 29.4).
Both therapists and participants had high scores on all aspects of the Working Alliance Inventory scale.
“High treatment retention, excellent client satisfaction, and strong working alliance scores support the feasibility and acceptability of this intervention for adolescents and young adults with bipolar disorder,” the investigators wrote.
Participants showed significant improvement in social rhythm regularity and reductions in depression and manic symptoms as well as suicide propensity (P = .016 for BSRS; .024 for HDRS-29; .028 for YMRS; and .028 for CHRT suicide propensity). Effect sizes were in the moderate to high range.
By the midpoint of the therapy, there were significant improvements in social rhythm regularity and suicide propensity and trend-level reductions in depression, suggesting the potential for early benefits.
Dr. Blumberg noted it is difficult to find a therapy that helps with both depressive and mania symptoms. “An antidepressant may reduce depression, but sometimes can worsen manic symptoms.”
Impact on emotional brain circuitry?
The association between improved regularity of social rhythms and reduced suicide propensity persisted even after controlling for mood symptom changes.
“Suicide risk was reduced not just because subjects were less depressed. There’s something about regularizing rhythms that can reduce suicide risk,” said Dr. Blumberg.
The reviewers noted that SRT administered remotely improves accessibility; and this intervention “is well suited to the future of psychotherapy delivery, which will undoubtedly include remote treatment delivery.”
The absence of a comparator condition was cited as a study limitation. The investigators noted the small sample size means the findings should be interpreted cautiously and verified in an adequately powered randomized controlled trial.
The researchers now have early results from the brain scanning component of the study. “Preliminary findings suggest the intervention seems to benefit emotional brain circuitry,” Dr. Blumberg said.
The researchers are about to embark on a new study funded by a grant from the American Foundation of Suicide Prevention. It will investigate SRT in preventing suicide in adolescents and adults to age 29 years with depression or BD.
In addition, the researchers have secured support from the Klingenstein Third Generation Foundation to research prevention in youth at risk for BD – and from Women’s Health Access Matters to examine the therapy in women 50 and older with depression, a population possibly at increased risk for dementia.
‘Promising’ results
Commenting on the findings, Michael Thase, MD, professor of psychiatry, University of Pennsylvania, and research psychiatrist at the Corporal Michael J. Crescenz Veterans Affairs Medical Center, both in Philadelphia, praised the study.
“It’s a very, very promising initial study because even though there’s no control group, it does show that participants liked the program, most finished it, and on average, people got quite a bit better,” said Dr. Thase, who was not involved with the research.
The treatment may be especially beneficial for young patients with bipolar disorder who, just by their very age, experience lifestyle disruptions, Dr. Thase noted. Results from a previous study of the therapeutic approach in adults showed “probably half of the adults didn’t take to it.”
However, not everyone in this new study benefited either, as some dropped out, which Dr. Thase noted is not atypical.
“No form of intervention is suitable for everyone,” he said.
The study was supported by grants from the National Institute of Mental Health, AIM Youth Mental Health Foundation, Klingenstein Third Generation Foundation, American Foundation for Suicide Prevention, International Bipolar Foundation, MQ Brighter Futures Program, For the Love of Travis Foundation, and the John and Hope Furth Endowment. Dr. Blumberg and Dr. Thase reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM THE AMERICAN JOURNAL OF PSYCHOTHERAPY
Reducing night-time checks is safe and helps patients sleep
Routine checks of vital signs during the night often prevent hospitalized patients from getting sufficient recuperative sleep. But patients who are judged to be clinically stable by an algorithm that uses real-time data can be safely spared these checks, according to a recent study published in JAMA Internal Medicine.
In their study,
“Sleep is crucial to health,” writes Hyung J. Cho, MD, from the New York University Grossman School of Medicine, in an accompanying editorial. “Ironically, hospitals, where people go to recover from illness, are among the most difficult places to sleep.”
Noise from the surrounding area, night-time examinations, multibed rooms, an unfamiliar environment, early morning blood sample collections, and frequent vital sign checks often prevent patients from sleeping through the night.
The goal of the study was to see if the elimination of one of these disrupting factors – the frequent checks of vital signs – would improve sleep and lead to a reduction in delirium, the primary endpoint.
To do this, the researchers incorporated a predictive algorithm they developed “to identify patients who are at low risk for abnormal night-time vital signs” into the hospitals electronic health records system. Attending physicians received a notification, based on real-time patient data, if it was predicted with a high degree of probability that a patient’s night-time vital signs would be within the normal range. Each physician was free to decide whether they would forgo night-time checks of the vital signs or whether they would turn off the notifications for a specific period.
The randomized clinical trial was conducted at a tertiary care academic teaching hospital from March to November 2019. Half the 1,930 patients were randomized to the algorithm group and half to standard care. None of the patients were receiving intensive care.
Number of night-time checks successfully reduced
The mean number of night-time checks was significantly lower in the algorithm group than in the standard-care group (0.97 vs. 1.41; P < .001).
The reduction in night-time checks had no effect on patient safety. There was no increase in transfers to the intensive care unit in the algorithm or standard-care groups (5% vs 5%; P = .92), and no difference between the number of heart alarms (0.2% vs. 0.9%; P = .07).
However, the reduction also had no effect on the incidence of episodes of delirium in the algorithm or standard-care groups (11% vs. 13%; P = .32).
“The reduction in vital signs checking, although statistically significant, was relatively small,” Dr. Cho explains. But the primary endpoint might have been different had the adherence to intervention been better, he notes.
In fact, the analysis confirmed that changes to routine daily practice in a hospital are not always easy to implement. In 35% of cases, the patients’ vital signs were checked at night, despite the physician’s order to the contrary.
“Busy patient-care assistants and nurses may check vital signs out of habit without noticing that the order has changed for some of the patients,” Dr. Najafi and his coauthors write. Many hospitals are used to thinking that regular measurements of the vital signs are part of good practice.
Include nursing staff
Future projects should use an interdisciplinary approach that includes nursing staff, Dr. Cho recommends. More user-friendly displays and optimized alerts in the electronic patient records could also encourage better implementation of the orders.
Less frequent checks of the vital signs would be welcomed by frontline staff because it would lighten their already heavy workload, he adds.
Although the study didn’t meet its primary endpoint, patients subjected to fewer night-time checks because of the algorithm were able to get a good night’s sleep. Other aspects of hospital care that are based on the patient’s stability, such as cardiac monitoring, could also potentially benefit from this type of intervention, Dr. Najafi and his colleagues suggest.
A version of this article first appeared on Medscape.com.
Routine checks of vital signs during the night often prevent hospitalized patients from getting sufficient recuperative sleep. But patients who are judged to be clinically stable by an algorithm that uses real-time data can be safely spared these checks, according to a recent study published in JAMA Internal Medicine.
In their study,
“Sleep is crucial to health,” writes Hyung J. Cho, MD, from the New York University Grossman School of Medicine, in an accompanying editorial. “Ironically, hospitals, where people go to recover from illness, are among the most difficult places to sleep.”
Noise from the surrounding area, night-time examinations, multibed rooms, an unfamiliar environment, early morning blood sample collections, and frequent vital sign checks often prevent patients from sleeping through the night.
The goal of the study was to see if the elimination of one of these disrupting factors – the frequent checks of vital signs – would improve sleep and lead to a reduction in delirium, the primary endpoint.
To do this, the researchers incorporated a predictive algorithm they developed “to identify patients who are at low risk for abnormal night-time vital signs” into the hospitals electronic health records system. Attending physicians received a notification, based on real-time patient data, if it was predicted with a high degree of probability that a patient’s night-time vital signs would be within the normal range. Each physician was free to decide whether they would forgo night-time checks of the vital signs or whether they would turn off the notifications for a specific period.
The randomized clinical trial was conducted at a tertiary care academic teaching hospital from March to November 2019. Half the 1,930 patients were randomized to the algorithm group and half to standard care. None of the patients were receiving intensive care.
Number of night-time checks successfully reduced
The mean number of night-time checks was significantly lower in the algorithm group than in the standard-care group (0.97 vs. 1.41; P < .001).
The reduction in night-time checks had no effect on patient safety. There was no increase in transfers to the intensive care unit in the algorithm or standard-care groups (5% vs 5%; P = .92), and no difference between the number of heart alarms (0.2% vs. 0.9%; P = .07).
However, the reduction also had no effect on the incidence of episodes of delirium in the algorithm or standard-care groups (11% vs. 13%; P = .32).
“The reduction in vital signs checking, although statistically significant, was relatively small,” Dr. Cho explains. But the primary endpoint might have been different had the adherence to intervention been better, he notes.
In fact, the analysis confirmed that changes to routine daily practice in a hospital are not always easy to implement. In 35% of cases, the patients’ vital signs were checked at night, despite the physician’s order to the contrary.
“Busy patient-care assistants and nurses may check vital signs out of habit without noticing that the order has changed for some of the patients,” Dr. Najafi and his coauthors write. Many hospitals are used to thinking that regular measurements of the vital signs are part of good practice.
Include nursing staff
Future projects should use an interdisciplinary approach that includes nursing staff, Dr. Cho recommends. More user-friendly displays and optimized alerts in the electronic patient records could also encourage better implementation of the orders.
Less frequent checks of the vital signs would be welcomed by frontline staff because it would lighten their already heavy workload, he adds.
Although the study didn’t meet its primary endpoint, patients subjected to fewer night-time checks because of the algorithm were able to get a good night’s sleep. Other aspects of hospital care that are based on the patient’s stability, such as cardiac monitoring, could also potentially benefit from this type of intervention, Dr. Najafi and his colleagues suggest.
A version of this article first appeared on Medscape.com.
Routine checks of vital signs during the night often prevent hospitalized patients from getting sufficient recuperative sleep. But patients who are judged to be clinically stable by an algorithm that uses real-time data can be safely spared these checks, according to a recent study published in JAMA Internal Medicine.
In their study,
“Sleep is crucial to health,” writes Hyung J. Cho, MD, from the New York University Grossman School of Medicine, in an accompanying editorial. “Ironically, hospitals, where people go to recover from illness, are among the most difficult places to sleep.”
Noise from the surrounding area, night-time examinations, multibed rooms, an unfamiliar environment, early morning blood sample collections, and frequent vital sign checks often prevent patients from sleeping through the night.
The goal of the study was to see if the elimination of one of these disrupting factors – the frequent checks of vital signs – would improve sleep and lead to a reduction in delirium, the primary endpoint.
To do this, the researchers incorporated a predictive algorithm they developed “to identify patients who are at low risk for abnormal night-time vital signs” into the hospitals electronic health records system. Attending physicians received a notification, based on real-time patient data, if it was predicted with a high degree of probability that a patient’s night-time vital signs would be within the normal range. Each physician was free to decide whether they would forgo night-time checks of the vital signs or whether they would turn off the notifications for a specific period.
The randomized clinical trial was conducted at a tertiary care academic teaching hospital from March to November 2019. Half the 1,930 patients were randomized to the algorithm group and half to standard care. None of the patients were receiving intensive care.
Number of night-time checks successfully reduced
The mean number of night-time checks was significantly lower in the algorithm group than in the standard-care group (0.97 vs. 1.41; P < .001).
The reduction in night-time checks had no effect on patient safety. There was no increase in transfers to the intensive care unit in the algorithm or standard-care groups (5% vs 5%; P = .92), and no difference between the number of heart alarms (0.2% vs. 0.9%; P = .07).
However, the reduction also had no effect on the incidence of episodes of delirium in the algorithm or standard-care groups (11% vs. 13%; P = .32).
“The reduction in vital signs checking, although statistically significant, was relatively small,” Dr. Cho explains. But the primary endpoint might have been different had the adherence to intervention been better, he notes.
In fact, the analysis confirmed that changes to routine daily practice in a hospital are not always easy to implement. In 35% of cases, the patients’ vital signs were checked at night, despite the physician’s order to the contrary.
“Busy patient-care assistants and nurses may check vital signs out of habit without noticing that the order has changed for some of the patients,” Dr. Najafi and his coauthors write. Many hospitals are used to thinking that regular measurements of the vital signs are part of good practice.
Include nursing staff
Future projects should use an interdisciplinary approach that includes nursing staff, Dr. Cho recommends. More user-friendly displays and optimized alerts in the electronic patient records could also encourage better implementation of the orders.
Less frequent checks of the vital signs would be welcomed by frontline staff because it would lighten their already heavy workload, he adds.
Although the study didn’t meet its primary endpoint, patients subjected to fewer night-time checks because of the algorithm were able to get a good night’s sleep. Other aspects of hospital care that are based on the patient’s stability, such as cardiac monitoring, could also potentially benefit from this type of intervention, Dr. Najafi and his colleagues suggest.
A version of this article first appeared on Medscape.com.
Sorting out sleep complaints in children with AD can be complex
according to Stephen H. Sheldon, DO.
“They wake up frequently,” Dr. Sheldon, professor of pediatrics and neurology at Northwestern University, Chicago, said during the Revolutionizing Atopic Dermatitis symposium. “They may not stay up for long periods of time, but they move about often. There’s a loss of about 50 minutes of sleep per night in children with AD. This loss can result in significant sleep debt the following day. They have difficulty settling at night. Once they get into bed, they have difficulty falling asleep, and many of them have difficulty staying asleep.”
At the sleep medicine center at Lurie Children’s Hospital of Chicago, he and his colleagues have observed that some children with AD complain of difficulty with limb movements. “Part of the issue has been that they have been diagnosed with different sleep-related disorders, such as period limb movement disorder, restless leg syndrome, and growing pain,” Dr. Sheldon said. “Often, they do not know how to describe the manifestations of their leg discomfort in restless leg syndrome and period limb movement disorder and limb movements of sleep.”
Children who complain of growing pains say that their legs hurt, he continued. Sometimes they’ll say that they feel like spiders are crawling on their legs, or that their legs itch, but they often say they have pain in their legs that wakes them up and keeps them from keeping their legs still.
According to the American Academy of Sleep Medicine, periodic limb movement disorder of sleep is characterized by frequent limb movements that last at least 0.5 seconds and are separated by no more than 90 seconds. “They’re four movements in a row that are at least 5 seconds apart,” Dr. Sheldon said.
Interestingly, he added, children who have limb movement disorder have symptoms during the day, similar to adults. “But we see many children with periodic limb movements of sleep whose arms and legs are moving all night, and they don’t have many symptoms during the day.” These children may have difficulty falling or staying asleep, but do not fulfill all of the American Academy of Sleep Medicine criteria for diagnosis of periodic limb movement disorder, he added.
In 2018, Lourdes M. DelRosso, MD, EdD, of Seattle Children’s Hospital, and colleagues described a new sleep problem they termed restless sleep disorder: those who do not fit the criteria for any other sleep disorder but have daytime impairment.
“On video they have very frequent movements – more than five movements an hour of major body activity,” Dr. Sheldon explained. “They’ll move their trunk, their legs, and reposition themselves. We have found that there are many children who presented to the sleep disorder center with restless sleep, limb movement disorder, periodic limb movements of sleep, and daytime symptoms that would fulfill the criteria of periodic limb movement disorder but also have atopic dermatitis.”
Recently, Dr. Sheldon and his colleagues used polysomnographic variables to study children who presented to Lurie Children’s Hospital with AD and symptoms such as difficulty maintaining sleep and snoring with allergic rhinitis. They found that there were increased periods of being awake after the onset of sleep, “meaning the children fell asleep fairly easily in the beginning of the night but they had significant wake after they fell asleep,” he said. “They would wake up in the middle of the night and stay awake for long periods of time – either one long session or multiple shorter sessions throughout the night. They had increased total limb movements per hour of sleep. This means that their limb movements were greater than five events per hour of sleep and it resulted in restless sleep and limb movements that would fulfill the criteria of periodic limb movement disorder.”
Most of these children had mild to moderate AD, he continued. “We feel that the sensory afferent loop in these youngsters doesn’t really turn off completely when they’re asleep. This is ripe for further study, but it makes intuitive sense that if the sensory afferent loop continues during sleep, it may affect the arousal system significantly.”
Dr. Sheldon recommended that any child who presents with a diagnosis of periodic limb movement disorder, periodic limb movements of sleep, or restless sleep disorder should be evaluated for AD. “The treatment then, would first require differentiation between periodic limb movement disorder of sleep and AD. Both should be addressed at the same time in order to solve the child’s daytime AD problem as well as the sleep-related issues that occur with an AD diagnosis.”
He reported having no financial disclosures.
according to Stephen H. Sheldon, DO.
“They wake up frequently,” Dr. Sheldon, professor of pediatrics and neurology at Northwestern University, Chicago, said during the Revolutionizing Atopic Dermatitis symposium. “They may not stay up for long periods of time, but they move about often. There’s a loss of about 50 minutes of sleep per night in children with AD. This loss can result in significant sleep debt the following day. They have difficulty settling at night. Once they get into bed, they have difficulty falling asleep, and many of them have difficulty staying asleep.”
At the sleep medicine center at Lurie Children’s Hospital of Chicago, he and his colleagues have observed that some children with AD complain of difficulty with limb movements. “Part of the issue has been that they have been diagnosed with different sleep-related disorders, such as period limb movement disorder, restless leg syndrome, and growing pain,” Dr. Sheldon said. “Often, they do not know how to describe the manifestations of their leg discomfort in restless leg syndrome and period limb movement disorder and limb movements of sleep.”
Children who complain of growing pains say that their legs hurt, he continued. Sometimes they’ll say that they feel like spiders are crawling on their legs, or that their legs itch, but they often say they have pain in their legs that wakes them up and keeps them from keeping their legs still.
According to the American Academy of Sleep Medicine, periodic limb movement disorder of sleep is characterized by frequent limb movements that last at least 0.5 seconds and are separated by no more than 90 seconds. “They’re four movements in a row that are at least 5 seconds apart,” Dr. Sheldon said.
Interestingly, he added, children who have limb movement disorder have symptoms during the day, similar to adults. “But we see many children with periodic limb movements of sleep whose arms and legs are moving all night, and they don’t have many symptoms during the day.” These children may have difficulty falling or staying asleep, but do not fulfill all of the American Academy of Sleep Medicine criteria for diagnosis of periodic limb movement disorder, he added.
In 2018, Lourdes M. DelRosso, MD, EdD, of Seattle Children’s Hospital, and colleagues described a new sleep problem they termed restless sleep disorder: those who do not fit the criteria for any other sleep disorder but have daytime impairment.
“On video they have very frequent movements – more than five movements an hour of major body activity,” Dr. Sheldon explained. “They’ll move their trunk, their legs, and reposition themselves. We have found that there are many children who presented to the sleep disorder center with restless sleep, limb movement disorder, periodic limb movements of sleep, and daytime symptoms that would fulfill the criteria of periodic limb movement disorder but also have atopic dermatitis.”
Recently, Dr. Sheldon and his colleagues used polysomnographic variables to study children who presented to Lurie Children’s Hospital with AD and symptoms such as difficulty maintaining sleep and snoring with allergic rhinitis. They found that there were increased periods of being awake after the onset of sleep, “meaning the children fell asleep fairly easily in the beginning of the night but they had significant wake after they fell asleep,” he said. “They would wake up in the middle of the night and stay awake for long periods of time – either one long session or multiple shorter sessions throughout the night. They had increased total limb movements per hour of sleep. This means that their limb movements were greater than five events per hour of sleep and it resulted in restless sleep and limb movements that would fulfill the criteria of periodic limb movement disorder.”
Most of these children had mild to moderate AD, he continued. “We feel that the sensory afferent loop in these youngsters doesn’t really turn off completely when they’re asleep. This is ripe for further study, but it makes intuitive sense that if the sensory afferent loop continues during sleep, it may affect the arousal system significantly.”
Dr. Sheldon recommended that any child who presents with a diagnosis of periodic limb movement disorder, periodic limb movements of sleep, or restless sleep disorder should be evaluated for AD. “The treatment then, would first require differentiation between periodic limb movement disorder of sleep and AD. Both should be addressed at the same time in order to solve the child’s daytime AD problem as well as the sleep-related issues that occur with an AD diagnosis.”
He reported having no financial disclosures.
according to Stephen H. Sheldon, DO.
“They wake up frequently,” Dr. Sheldon, professor of pediatrics and neurology at Northwestern University, Chicago, said during the Revolutionizing Atopic Dermatitis symposium. “They may not stay up for long periods of time, but they move about often. There’s a loss of about 50 minutes of sleep per night in children with AD. This loss can result in significant sleep debt the following day. They have difficulty settling at night. Once they get into bed, they have difficulty falling asleep, and many of them have difficulty staying asleep.”
At the sleep medicine center at Lurie Children’s Hospital of Chicago, he and his colleagues have observed that some children with AD complain of difficulty with limb movements. “Part of the issue has been that they have been diagnosed with different sleep-related disorders, such as period limb movement disorder, restless leg syndrome, and growing pain,” Dr. Sheldon said. “Often, they do not know how to describe the manifestations of their leg discomfort in restless leg syndrome and period limb movement disorder and limb movements of sleep.”
Children who complain of growing pains say that their legs hurt, he continued. Sometimes they’ll say that they feel like spiders are crawling on their legs, or that their legs itch, but they often say they have pain in their legs that wakes them up and keeps them from keeping their legs still.
According to the American Academy of Sleep Medicine, periodic limb movement disorder of sleep is characterized by frequent limb movements that last at least 0.5 seconds and are separated by no more than 90 seconds. “They’re four movements in a row that are at least 5 seconds apart,” Dr. Sheldon said.
Interestingly, he added, children who have limb movement disorder have symptoms during the day, similar to adults. “But we see many children with periodic limb movements of sleep whose arms and legs are moving all night, and they don’t have many symptoms during the day.” These children may have difficulty falling or staying asleep, but do not fulfill all of the American Academy of Sleep Medicine criteria for diagnosis of periodic limb movement disorder, he added.
In 2018, Lourdes M. DelRosso, MD, EdD, of Seattle Children’s Hospital, and colleagues described a new sleep problem they termed restless sleep disorder: those who do not fit the criteria for any other sleep disorder but have daytime impairment.
“On video they have very frequent movements – more than five movements an hour of major body activity,” Dr. Sheldon explained. “They’ll move their trunk, their legs, and reposition themselves. We have found that there are many children who presented to the sleep disorder center with restless sleep, limb movement disorder, periodic limb movements of sleep, and daytime symptoms that would fulfill the criteria of periodic limb movement disorder but also have atopic dermatitis.”
Recently, Dr. Sheldon and his colleagues used polysomnographic variables to study children who presented to Lurie Children’s Hospital with AD and symptoms such as difficulty maintaining sleep and snoring with allergic rhinitis. They found that there were increased periods of being awake after the onset of sleep, “meaning the children fell asleep fairly easily in the beginning of the night but they had significant wake after they fell asleep,” he said. “They would wake up in the middle of the night and stay awake for long periods of time – either one long session or multiple shorter sessions throughout the night. They had increased total limb movements per hour of sleep. This means that their limb movements were greater than five events per hour of sleep and it resulted in restless sleep and limb movements that would fulfill the criteria of periodic limb movement disorder.”
Most of these children had mild to moderate AD, he continued. “We feel that the sensory afferent loop in these youngsters doesn’t really turn off completely when they’re asleep. This is ripe for further study, but it makes intuitive sense that if the sensory afferent loop continues during sleep, it may affect the arousal system significantly.”
Dr. Sheldon recommended that any child who presents with a diagnosis of periodic limb movement disorder, periodic limb movements of sleep, or restless sleep disorder should be evaluated for AD. “The treatment then, would first require differentiation between periodic limb movement disorder of sleep and AD. Both should be addressed at the same time in order to solve the child’s daytime AD problem as well as the sleep-related issues that occur with an AD diagnosis.”
He reported having no financial disclosures.
FROM RAD 2021