Both Promise and Concern for OSA and CPAP with GLP-1s

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Changed
Fri, 04/19/2024 - 13:47

 

Will the weight reduction success with glucagon-like peptide-1 (GLP-1) agonists translate into strong reductions in obstructive sleep apnea (OSA)? Will those potential OSA benefits obviate the need in many for continuous positive airway pressure (CPAP)? Experts are voicing high hopes while citing important health equity concerns and reluctance to de-emphasize lifestyle remedies.

“I think it’s a game changer for helping people who are overweight or obese,” Samuel T. Kuna, MD, chief of sleep medicine at the Corporal Michael J. Crescenz VA Medical Center in Philadelphia, said in an interview with CHEST Physician. “I think we’re just starting out on a very exciting new era. We finally have quite effective treatments for this population.” Dr. Kuna’s Sleep AHEAD (Action for Health in Diabetes) 2021 study (doi: 10.1164/rccm.201912-2511OC) found that participants with OSA and type 2 diabetes mellitus receiving intensive lifestyle interventions for weight loss had reduced OSA severity at 10 years, and that OSA remission at 10 years was more common with intensive lifestyle intervention than with diabetes support and education.

Potential for OSA impact

In a JAMA Network Open/Pulmonary Medicine article on a 2022 study (doi: 10.1001/jamanetworkopen.2022.8212) conducted among 89 Spanish male adults with moderate to severe OSA and body mass index of 25 or greater, participants received CPAP therapy with or without 8 weeks of weight loss and lifestyle intervention. The primary endpoint of apnea-hypopnea index at 6 months showed the intervention to yield “clinically meaningful and sustainable improvements in OSA.”

Dr. Kuna stated, “I don’t think these [weight loss] agents eliminate the importance of behavioral modification, of changing diet, of reducing highly processed foods and maintaining a healthy lifestyle.” He acknowledged, however, that behavioral endeavors have been in general disappointing with respect to patients’ ability to achieve weight loss. “These medicines really open up a new strategy to help patients do that,” he added.

Milleflore Images/Shutterstock


Dr. Kuna pointed to a recent (2023) Grunstein et al. perspective article (doi: 10.1093/sleep/zsad224) published in Sleep citing phase 3 trial results showing placebo-subtracted weight loss percentages. With subcutaneous (SC) semaglutide 2.4 mg they were 12.6% in patients with obesity or overweight with one or more weight-related comorbidities (but not type 2 diabetes), and 17.8% with tirzepatide (15 mg, SC, weekly), a combination GLP-1 agonist and glucose-dependent insulinotropic polypeptide agonist, in a similar population. The authors stated, “These new agents, provided they are available to persons who need them most — who are often socioeconomically disadvantaged — could revolutionize the management of obesity and its many complications, including OSA.” Grunstein et al. also, noted that the number of studies showing improvement in cardiometabolic outcomes (eg, blood pressure) with pre-incretin OSA therapies are “minimal.” They underscored, however, the need for risk/benefit/cost-effectiveness data on incretin therapies, and cited evidence that withdrawal from incretin treatment brings back weight gain and adverse cardiometabolic factors. They also indicated key areas of uncertainty requiring research: gender-based response differences to incretins (women predominate in most weight loss studies, but OSA is more common in men), how CPAP users will adapt to incretin OSA benefits, direct comparisons of impact on OSA with incretins vs mechanical therapy, and understanding which target populations derive the most benefit with incretin therapies.

Despite the unanswered questions, the direction was unequivocally clear for Grunstein et al.: “Ultimately, the focus must shift away from mechanical therapy for obesity-related OSA towards weight loss, the latter which is likely to produce multiple health outcome improvements that are superior, including all-cause mortality.”

Dr. Kuna agreed with the Sleep article authors that one implication of this “incretin revolution” is that sleep physicians will have to broaden their skills to encompass obesity management. “As the field evolves, perhaps we should start training our fellows about how to manage these patients,” Dr. Kuna said.
 

 

 

Significant impact on OSA and CPAP

“Obesity is a risk factor for sleep apnea,” stated Saadia A. Faiz, MD, FCCP, professor, Department of Pulmonary Medicine, University of Texas MD Anderson Cancer Center, Houston, “so with increased use of these GLP-1 agents for weight reduction, we would anticipate a significant impact on both OSA severity and need for CPAP.” Speaking in a CHEST Physician interview and referring to the Kuna et al. study, she stated, “Since cessation of the drug can lead to rebound weight gain, the emphasis on healthy eating and exercise is crucial to management.” Dr. Faiz said further, “It’s important to note that there are other weight-independent mechanisms for OSA, including upper airway anatomy, mechanisms that modulate upper airway stability, chemoreceptor sensitivity, visceral adiposity, neuroendocrine control, sleep quality, and other aspects of OSA pathophysiology yet to be discovered.”

Dr. Saadia A. Faiz

 

Cost an obstacle for some

“For many insurances, criteria for coverage include obesity and prediabetes based on HbA1c. For some not meeting requirements, they will have to pay out of pocket,” Dr. Faiz said. She pointed to a Respirology (doi: 10.1111/resp.14545) commentary in which Garun S. Hamilton, MBBS, PhD, and Bradley A. Edwards, PhD, underscored the nearly 1 billion people worldwide with OSA, most of whom are overweight or obese. “GLP-1 agonists are so effective that they have become a worldwide phenomenon. The high cost of the medications combined with the high prevalence of OSA means that there is no way that universal healthcare funding schemes can afford these medications, unless strict criteria are in place to prioritize those who can gain subsidized access and/or a duration of use limit is in place,” they stated. “This will no doubt exacerbate inequities in healthcare access and outcome between those from lower versus higher socioeconomic populations, as the attributable benefit from GLP-1 agonists is likely to be dependent on a patient’s ability to afford them.”
 

Beyond health equity concerns

The evidence for clinically relevant reductions in weight and resultant lowering of other adverse risk factors supports a wide embrace of Ozempic-type drugs. Standing alongside, however, are the cautionary pleas of nutrition/lifestyle-focused health advocates. They urge that prescriptions for nonpharmacological strategies that promote better sleep, healthier food choices, and more exercise need sharper highlighting and strong incentivizing.

Dr. Faiz said, “The availability and consumption of ultra-processed foods can impact food intake and weight. Specifically, in a small study of 20 inpatient adults admitted to the NIH Clinical Center randomized to either ultra-processed or unprocessed diets for 14 days, increased caloric intake and weight gain were found in the ultra-processed cohort.” In the study Dr. Faiz cited (doi: 10.1016/j.cmet.2019.05.008), meals were matched for calories, energy density, macronutrients, sugar, sodium, and fiber. Subjects were instructed to consume as much or as little as desired. Analysis showed a 4-pound weight difference between groups within 2 weeks: The ultra-processed cohort had taken in an extra 500 calories a day and had gained weight (0.9 ± 0.3 kg [P = .009]) and body fat while the unprocessed food group lost weight (0.9 ± 0.3 kg [P = .007]) and body fat.

“Thus, the type of foods we opt for can also have significant impact,” Dr. Faiz stated.

Dr. Faiz and Dr. Kuna said they had no conflicts of interest to disclose.

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Will the weight reduction success with glucagon-like peptide-1 (GLP-1) agonists translate into strong reductions in obstructive sleep apnea (OSA)? Will those potential OSA benefits obviate the need in many for continuous positive airway pressure (CPAP)? Experts are voicing high hopes while citing important health equity concerns and reluctance to de-emphasize lifestyle remedies.

“I think it’s a game changer for helping people who are overweight or obese,” Samuel T. Kuna, MD, chief of sleep medicine at the Corporal Michael J. Crescenz VA Medical Center in Philadelphia, said in an interview with CHEST Physician. “I think we’re just starting out on a very exciting new era. We finally have quite effective treatments for this population.” Dr. Kuna’s Sleep AHEAD (Action for Health in Diabetes) 2021 study (doi: 10.1164/rccm.201912-2511OC) found that participants with OSA and type 2 diabetes mellitus receiving intensive lifestyle interventions for weight loss had reduced OSA severity at 10 years, and that OSA remission at 10 years was more common with intensive lifestyle intervention than with diabetes support and education.

Potential for OSA impact

In a JAMA Network Open/Pulmonary Medicine article on a 2022 study (doi: 10.1001/jamanetworkopen.2022.8212) conducted among 89 Spanish male adults with moderate to severe OSA and body mass index of 25 or greater, participants received CPAP therapy with or without 8 weeks of weight loss and lifestyle intervention. The primary endpoint of apnea-hypopnea index at 6 months showed the intervention to yield “clinically meaningful and sustainable improvements in OSA.”

Dr. Kuna stated, “I don’t think these [weight loss] agents eliminate the importance of behavioral modification, of changing diet, of reducing highly processed foods and maintaining a healthy lifestyle.” He acknowledged, however, that behavioral endeavors have been in general disappointing with respect to patients’ ability to achieve weight loss. “These medicines really open up a new strategy to help patients do that,” he added.

Milleflore Images/Shutterstock


Dr. Kuna pointed to a recent (2023) Grunstein et al. perspective article (doi: 10.1093/sleep/zsad224) published in Sleep citing phase 3 trial results showing placebo-subtracted weight loss percentages. With subcutaneous (SC) semaglutide 2.4 mg they were 12.6% in patients with obesity or overweight with one or more weight-related comorbidities (but not type 2 diabetes), and 17.8% with tirzepatide (15 mg, SC, weekly), a combination GLP-1 agonist and glucose-dependent insulinotropic polypeptide agonist, in a similar population. The authors stated, “These new agents, provided they are available to persons who need them most — who are often socioeconomically disadvantaged — could revolutionize the management of obesity and its many complications, including OSA.” Grunstein et al. also, noted that the number of studies showing improvement in cardiometabolic outcomes (eg, blood pressure) with pre-incretin OSA therapies are “minimal.” They underscored, however, the need for risk/benefit/cost-effectiveness data on incretin therapies, and cited evidence that withdrawal from incretin treatment brings back weight gain and adverse cardiometabolic factors. They also indicated key areas of uncertainty requiring research: gender-based response differences to incretins (women predominate in most weight loss studies, but OSA is more common in men), how CPAP users will adapt to incretin OSA benefits, direct comparisons of impact on OSA with incretins vs mechanical therapy, and understanding which target populations derive the most benefit with incretin therapies.

Despite the unanswered questions, the direction was unequivocally clear for Grunstein et al.: “Ultimately, the focus must shift away from mechanical therapy for obesity-related OSA towards weight loss, the latter which is likely to produce multiple health outcome improvements that are superior, including all-cause mortality.”

Dr. Kuna agreed with the Sleep article authors that one implication of this “incretin revolution” is that sleep physicians will have to broaden their skills to encompass obesity management. “As the field evolves, perhaps we should start training our fellows about how to manage these patients,” Dr. Kuna said.
 

 

 

Significant impact on OSA and CPAP

“Obesity is a risk factor for sleep apnea,” stated Saadia A. Faiz, MD, FCCP, professor, Department of Pulmonary Medicine, University of Texas MD Anderson Cancer Center, Houston, “so with increased use of these GLP-1 agents for weight reduction, we would anticipate a significant impact on both OSA severity and need for CPAP.” Speaking in a CHEST Physician interview and referring to the Kuna et al. study, she stated, “Since cessation of the drug can lead to rebound weight gain, the emphasis on healthy eating and exercise is crucial to management.” Dr. Faiz said further, “It’s important to note that there are other weight-independent mechanisms for OSA, including upper airway anatomy, mechanisms that modulate upper airway stability, chemoreceptor sensitivity, visceral adiposity, neuroendocrine control, sleep quality, and other aspects of OSA pathophysiology yet to be discovered.”

Dr. Saadia A. Faiz

 

Cost an obstacle for some

“For many insurances, criteria for coverage include obesity and prediabetes based on HbA1c. For some not meeting requirements, they will have to pay out of pocket,” Dr. Faiz said. She pointed to a Respirology (doi: 10.1111/resp.14545) commentary in which Garun S. Hamilton, MBBS, PhD, and Bradley A. Edwards, PhD, underscored the nearly 1 billion people worldwide with OSA, most of whom are overweight or obese. “GLP-1 agonists are so effective that they have become a worldwide phenomenon. The high cost of the medications combined with the high prevalence of OSA means that there is no way that universal healthcare funding schemes can afford these medications, unless strict criteria are in place to prioritize those who can gain subsidized access and/or a duration of use limit is in place,” they stated. “This will no doubt exacerbate inequities in healthcare access and outcome between those from lower versus higher socioeconomic populations, as the attributable benefit from GLP-1 agonists is likely to be dependent on a patient’s ability to afford them.”
 

Beyond health equity concerns

The evidence for clinically relevant reductions in weight and resultant lowering of other adverse risk factors supports a wide embrace of Ozempic-type drugs. Standing alongside, however, are the cautionary pleas of nutrition/lifestyle-focused health advocates. They urge that prescriptions for nonpharmacological strategies that promote better sleep, healthier food choices, and more exercise need sharper highlighting and strong incentivizing.

Dr. Faiz said, “The availability and consumption of ultra-processed foods can impact food intake and weight. Specifically, in a small study of 20 inpatient adults admitted to the NIH Clinical Center randomized to either ultra-processed or unprocessed diets for 14 days, increased caloric intake and weight gain were found in the ultra-processed cohort.” In the study Dr. Faiz cited (doi: 10.1016/j.cmet.2019.05.008), meals were matched for calories, energy density, macronutrients, sugar, sodium, and fiber. Subjects were instructed to consume as much or as little as desired. Analysis showed a 4-pound weight difference between groups within 2 weeks: The ultra-processed cohort had taken in an extra 500 calories a day and had gained weight (0.9 ± 0.3 kg [P = .009]) and body fat while the unprocessed food group lost weight (0.9 ± 0.3 kg [P = .007]) and body fat.

“Thus, the type of foods we opt for can also have significant impact,” Dr. Faiz stated.

Dr. Faiz and Dr. Kuna said they had no conflicts of interest to disclose.

 

Will the weight reduction success with glucagon-like peptide-1 (GLP-1) agonists translate into strong reductions in obstructive sleep apnea (OSA)? Will those potential OSA benefits obviate the need in many for continuous positive airway pressure (CPAP)? Experts are voicing high hopes while citing important health equity concerns and reluctance to de-emphasize lifestyle remedies.

“I think it’s a game changer for helping people who are overweight or obese,” Samuel T. Kuna, MD, chief of sleep medicine at the Corporal Michael J. Crescenz VA Medical Center in Philadelphia, said in an interview with CHEST Physician. “I think we’re just starting out on a very exciting new era. We finally have quite effective treatments for this population.” Dr. Kuna’s Sleep AHEAD (Action for Health in Diabetes) 2021 study (doi: 10.1164/rccm.201912-2511OC) found that participants with OSA and type 2 diabetes mellitus receiving intensive lifestyle interventions for weight loss had reduced OSA severity at 10 years, and that OSA remission at 10 years was more common with intensive lifestyle intervention than with diabetes support and education.

Potential for OSA impact

In a JAMA Network Open/Pulmonary Medicine article on a 2022 study (doi: 10.1001/jamanetworkopen.2022.8212) conducted among 89 Spanish male adults with moderate to severe OSA and body mass index of 25 or greater, participants received CPAP therapy with or without 8 weeks of weight loss and lifestyle intervention. The primary endpoint of apnea-hypopnea index at 6 months showed the intervention to yield “clinically meaningful and sustainable improvements in OSA.”

Dr. Kuna stated, “I don’t think these [weight loss] agents eliminate the importance of behavioral modification, of changing diet, of reducing highly processed foods and maintaining a healthy lifestyle.” He acknowledged, however, that behavioral endeavors have been in general disappointing with respect to patients’ ability to achieve weight loss. “These medicines really open up a new strategy to help patients do that,” he added.

Milleflore Images/Shutterstock


Dr. Kuna pointed to a recent (2023) Grunstein et al. perspective article (doi: 10.1093/sleep/zsad224) published in Sleep citing phase 3 trial results showing placebo-subtracted weight loss percentages. With subcutaneous (SC) semaglutide 2.4 mg they were 12.6% in patients with obesity or overweight with one or more weight-related comorbidities (but not type 2 diabetes), and 17.8% with tirzepatide (15 mg, SC, weekly), a combination GLP-1 agonist and glucose-dependent insulinotropic polypeptide agonist, in a similar population. The authors stated, “These new agents, provided they are available to persons who need them most — who are often socioeconomically disadvantaged — could revolutionize the management of obesity and its many complications, including OSA.” Grunstein et al. also, noted that the number of studies showing improvement in cardiometabolic outcomes (eg, blood pressure) with pre-incretin OSA therapies are “minimal.” They underscored, however, the need for risk/benefit/cost-effectiveness data on incretin therapies, and cited evidence that withdrawal from incretin treatment brings back weight gain and adverse cardiometabolic factors. They also indicated key areas of uncertainty requiring research: gender-based response differences to incretins (women predominate in most weight loss studies, but OSA is more common in men), how CPAP users will adapt to incretin OSA benefits, direct comparisons of impact on OSA with incretins vs mechanical therapy, and understanding which target populations derive the most benefit with incretin therapies.

Despite the unanswered questions, the direction was unequivocally clear for Grunstein et al.: “Ultimately, the focus must shift away from mechanical therapy for obesity-related OSA towards weight loss, the latter which is likely to produce multiple health outcome improvements that are superior, including all-cause mortality.”

Dr. Kuna agreed with the Sleep article authors that one implication of this “incretin revolution” is that sleep physicians will have to broaden their skills to encompass obesity management. “As the field evolves, perhaps we should start training our fellows about how to manage these patients,” Dr. Kuna said.
 

 

 

Significant impact on OSA and CPAP

“Obesity is a risk factor for sleep apnea,” stated Saadia A. Faiz, MD, FCCP, professor, Department of Pulmonary Medicine, University of Texas MD Anderson Cancer Center, Houston, “so with increased use of these GLP-1 agents for weight reduction, we would anticipate a significant impact on both OSA severity and need for CPAP.” Speaking in a CHEST Physician interview and referring to the Kuna et al. study, she stated, “Since cessation of the drug can lead to rebound weight gain, the emphasis on healthy eating and exercise is crucial to management.” Dr. Faiz said further, “It’s important to note that there are other weight-independent mechanisms for OSA, including upper airway anatomy, mechanisms that modulate upper airway stability, chemoreceptor sensitivity, visceral adiposity, neuroendocrine control, sleep quality, and other aspects of OSA pathophysiology yet to be discovered.”

Dr. Saadia A. Faiz

 

Cost an obstacle for some

“For many insurances, criteria for coverage include obesity and prediabetes based on HbA1c. For some not meeting requirements, they will have to pay out of pocket,” Dr. Faiz said. She pointed to a Respirology (doi: 10.1111/resp.14545) commentary in which Garun S. Hamilton, MBBS, PhD, and Bradley A. Edwards, PhD, underscored the nearly 1 billion people worldwide with OSA, most of whom are overweight or obese. “GLP-1 agonists are so effective that they have become a worldwide phenomenon. The high cost of the medications combined with the high prevalence of OSA means that there is no way that universal healthcare funding schemes can afford these medications, unless strict criteria are in place to prioritize those who can gain subsidized access and/or a duration of use limit is in place,” they stated. “This will no doubt exacerbate inequities in healthcare access and outcome between those from lower versus higher socioeconomic populations, as the attributable benefit from GLP-1 agonists is likely to be dependent on a patient’s ability to afford them.”
 

Beyond health equity concerns

The evidence for clinically relevant reductions in weight and resultant lowering of other adverse risk factors supports a wide embrace of Ozempic-type drugs. Standing alongside, however, are the cautionary pleas of nutrition/lifestyle-focused health advocates. They urge that prescriptions for nonpharmacological strategies that promote better sleep, healthier food choices, and more exercise need sharper highlighting and strong incentivizing.

Dr. Faiz said, “The availability and consumption of ultra-processed foods can impact food intake and weight. Specifically, in a small study of 20 inpatient adults admitted to the NIH Clinical Center randomized to either ultra-processed or unprocessed diets for 14 days, increased caloric intake and weight gain were found in the ultra-processed cohort.” In the study Dr. Faiz cited (doi: 10.1016/j.cmet.2019.05.008), meals were matched for calories, energy density, macronutrients, sugar, sodium, and fiber. Subjects were instructed to consume as much or as little as desired. Analysis showed a 4-pound weight difference between groups within 2 weeks: The ultra-processed cohort had taken in an extra 500 calories a day and had gained weight (0.9 ± 0.3 kg [P = .009]) and body fat while the unprocessed food group lost weight (0.9 ± 0.3 kg [P = .007]) and body fat.

“Thus, the type of foods we opt for can also have significant impact,” Dr. Faiz stated.

Dr. Faiz and Dr. Kuna said they had no conflicts of interest to disclose.

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Eli Lilly to Ask FDA to Approve Weight Loss Drug for Sleep Apnea

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Mon, 04/22/2024 - 11:34

 

Results from a preliminary clinical trial demonstrated the obesity drug, tirzepatide, effectively treated obstructive sleep apnea (OSA), according to information sent to investors of the pharmaceutical company, Eli Lilly.

Indiana-based Eli Lilly sells tirzepatide under the brand name Zepbound, which was approved by the FDA in November to treat overweight and obesity. Tirzepatide is also marketed under the name Mounjaro to treat diabetes, and it’s among the same class of drugs as other well-known weight loss and diabetes drugs like Ozempic and Wegovy.

The newly announced results came from a pair of studies that followed people with moderate to severe OSA who also had obesity. People in the study took tirzepatide, which is given by injection, for one year. One study evaluated people who were using CPAP during sleep, and another study included people who didn’t use the device. People in both studies taking tirzepatide had significant reductions in sleep events and also lost about 20% of body weight. About 70% of people in the studies were men.

The findings have not yet been published in a peer-reviewed medical journal, and the preliminary results were announced by Eli Lilly because of reporting requirements related to information that could affect stock prices. The company indicated that detailed results will be presented at a conference of the American Diabetes Association in June and will be submitted to a peer-reviewed journal for consideration of publication. The company also plans to submit the information to the FDA for approval consideration mid-year, the investor news release stated.

People in the study taking tirzepatide on average experienced 63% fewer instances of reduced oxygen due to breathing changes, or events when breathing entirely stopped, Eli Lilly reported.

A sleep expert from Washington University in St. Louis told The New York Times the initial findings were extremely positive and noted that tirzepatide works to treat the underlying cause of sleep apnea, rather than current treatments that just address symptoms.

Tirzepatide “is a great alternative for people who are obese and can’t use CPAP or are on CPAP and want to improve the effect,” Eric Landsness, MD, PhD, told The New York Times. 

Eli Lilly indicated the most commonly reported adverse events in the studies were diarrhea, nausea, vomiting, and constipation.

An estimated 39 million people have OSA and about 33 million people use CPAP machines, according to The National Council on Aging. The condition has been increasingly diagnosed in recent years and becomes more likely to affect people as they get older.

A version of this article appeared on WebMD.com.

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Results from a preliminary clinical trial demonstrated the obesity drug, tirzepatide, effectively treated obstructive sleep apnea (OSA), according to information sent to investors of the pharmaceutical company, Eli Lilly.

Indiana-based Eli Lilly sells tirzepatide under the brand name Zepbound, which was approved by the FDA in November to treat overweight and obesity. Tirzepatide is also marketed under the name Mounjaro to treat diabetes, and it’s among the same class of drugs as other well-known weight loss and diabetes drugs like Ozempic and Wegovy.

The newly announced results came from a pair of studies that followed people with moderate to severe OSA who also had obesity. People in the study took tirzepatide, which is given by injection, for one year. One study evaluated people who were using CPAP during sleep, and another study included people who didn’t use the device. People in both studies taking tirzepatide had significant reductions in sleep events and also lost about 20% of body weight. About 70% of people in the studies were men.

The findings have not yet been published in a peer-reviewed medical journal, and the preliminary results were announced by Eli Lilly because of reporting requirements related to information that could affect stock prices. The company indicated that detailed results will be presented at a conference of the American Diabetes Association in June and will be submitted to a peer-reviewed journal for consideration of publication. The company also plans to submit the information to the FDA for approval consideration mid-year, the investor news release stated.

People in the study taking tirzepatide on average experienced 63% fewer instances of reduced oxygen due to breathing changes, or events when breathing entirely stopped, Eli Lilly reported.

A sleep expert from Washington University in St. Louis told The New York Times the initial findings were extremely positive and noted that tirzepatide works to treat the underlying cause of sleep apnea, rather than current treatments that just address symptoms.

Tirzepatide “is a great alternative for people who are obese and can’t use CPAP or are on CPAP and want to improve the effect,” Eric Landsness, MD, PhD, told The New York Times. 

Eli Lilly indicated the most commonly reported adverse events in the studies were diarrhea, nausea, vomiting, and constipation.

An estimated 39 million people have OSA and about 33 million people use CPAP machines, according to The National Council on Aging. The condition has been increasingly diagnosed in recent years and becomes more likely to affect people as they get older.

A version of this article appeared on WebMD.com.

 

Results from a preliminary clinical trial demonstrated the obesity drug, tirzepatide, effectively treated obstructive sleep apnea (OSA), according to information sent to investors of the pharmaceutical company, Eli Lilly.

Indiana-based Eli Lilly sells tirzepatide under the brand name Zepbound, which was approved by the FDA in November to treat overweight and obesity. Tirzepatide is also marketed under the name Mounjaro to treat diabetes, and it’s among the same class of drugs as other well-known weight loss and diabetes drugs like Ozempic and Wegovy.

The newly announced results came from a pair of studies that followed people with moderate to severe OSA who also had obesity. People in the study took tirzepatide, which is given by injection, for one year. One study evaluated people who were using CPAP during sleep, and another study included people who didn’t use the device. People in both studies taking tirzepatide had significant reductions in sleep events and also lost about 20% of body weight. About 70% of people in the studies were men.

The findings have not yet been published in a peer-reviewed medical journal, and the preliminary results were announced by Eli Lilly because of reporting requirements related to information that could affect stock prices. The company indicated that detailed results will be presented at a conference of the American Diabetes Association in June and will be submitted to a peer-reviewed journal for consideration of publication. The company also plans to submit the information to the FDA for approval consideration mid-year, the investor news release stated.

People in the study taking tirzepatide on average experienced 63% fewer instances of reduced oxygen due to breathing changes, or events when breathing entirely stopped, Eli Lilly reported.

A sleep expert from Washington University in St. Louis told The New York Times the initial findings were extremely positive and noted that tirzepatide works to treat the underlying cause of sleep apnea, rather than current treatments that just address symptoms.

Tirzepatide “is a great alternative for people who are obese and can’t use CPAP or are on CPAP and want to improve the effect,” Eric Landsness, MD, PhD, told The New York Times. 

Eli Lilly indicated the most commonly reported adverse events in the studies were diarrhea, nausea, vomiting, and constipation.

An estimated 39 million people have OSA and about 33 million people use CPAP machines, according to The National Council on Aging. The condition has been increasingly diagnosed in recent years and becomes more likely to affect people as they get older.

A version of this article appeared on WebMD.com.

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Too Little Sleep Raises Health Risks for Teens With T1D

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Thu, 04/18/2024 - 14:24

 

TOPLINE:

Less than 7 hours of sleep per night is common in individuals with type 1 diabetes (T1D) but is tied to poor cardiometabolic health, particularly in adolescents.

METHODOLOGY:

  • Sleep is recognized as an important factor in diabetes assessment and treatment by the 2023 American Diabetes Association’s Standards of Medical Care in Diabetes, but it is unclear whether sleep may improve health outcomes across the lifespan in patients with T1D.
  • This secondary analysis of the BCQR-T1D crossover trial investigated the link between sleep and cardiometabolic health in 42 adults (age, 19-60 years) and 42 adolescents (age, 12-18 years) with T1D.
  • Participants had T1D duration greater than 9 months and received bromocriptine quick-release (BCQR) therapy or placebo for 4 weeks and then switched between the treatments in a separate 4-week period.
  • They underwent laboratory testing and anthropometric measurements. Also, continuous glucose monitoring data were collected for a week during each treatment phase along with an accompanying insulin dosing diary.
  • Participants were required to wear an actigraphy monitor on the wrist of their nondominant hand for 7 days during each treatment phase to estimate sleep duration.

TAKEAWAY:

  • Most adolescents (62%) and adults (74%) with T1D reported less than 7 hours of sleep at baseline.
  • Participants with insufficient sleep versus those without insufficient sleep (< 7 vs > 7 hours) had a larger waist circumference and higher mean body mass index, systolic blood pressure, and pulse pressure, as well as lower estimated insulin sensitivity and brachial artery distensibility (P < .05 for all).
  • When stratified by age, only adolescents with T1D with insufficient sleep had significant differences in most health outcomes by sleep duration status, except that adults with less than 7 hours of sleep had higher pulse pressure than those with more than 7 hours of sleep.
  • Compared with placebo, BCQR slightly improved sleeping parameters in adolescents by delaying their time of waking up and prolonging their time in bed.

IN PRACTICE:

“Sleep may be an important and novel target for improving health in individuals with T1D, particularly when initiated in adolescence or early in diabetes,” the authors wrote.

SOURCE:

Stacey L. Simon, PhD, and Janet K. Snell-Bergeon, PhD, University of Colorado Anschutz Medical Campus, Aurora, led this study, which was published online in Diabetes, Obesity and Metabolism.

LIMITATIONS:

The study lacked polysomnography or melatonin assessment to quantify circadian rhythms and subjective sleep quality ratings. It also had no objective measurement of the timing of the daily pills of BCQR, which, when taken in the morning, are hypothesized to reset the circadian rhythm for hypothalamic dopamine and serotonin. The recommended sleep duration of 8 hours for adolescents was not used as the cutoff value due to too few participants who qualified. Also, this study›s findings may be affected by the fact that participants were recruited throughout the year, while adolescents show different sleeping patterns during the academic year compared with school breaks.

 

 

DISCLOSURES:

This work was supported by a JDRF grant. Two authors declared receiving equipment, honoraria for lectures, and support for conference travel, which were all unrelated to this study.

A version of this article appeared on Medscape.com.

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TOPLINE:

Less than 7 hours of sleep per night is common in individuals with type 1 diabetes (T1D) but is tied to poor cardiometabolic health, particularly in adolescents.

METHODOLOGY:

  • Sleep is recognized as an important factor in diabetes assessment and treatment by the 2023 American Diabetes Association’s Standards of Medical Care in Diabetes, but it is unclear whether sleep may improve health outcomes across the lifespan in patients with T1D.
  • This secondary analysis of the BCQR-T1D crossover trial investigated the link between sleep and cardiometabolic health in 42 adults (age, 19-60 years) and 42 adolescents (age, 12-18 years) with T1D.
  • Participants had T1D duration greater than 9 months and received bromocriptine quick-release (BCQR) therapy or placebo for 4 weeks and then switched between the treatments in a separate 4-week period.
  • They underwent laboratory testing and anthropometric measurements. Also, continuous glucose monitoring data were collected for a week during each treatment phase along with an accompanying insulin dosing diary.
  • Participants were required to wear an actigraphy monitor on the wrist of their nondominant hand for 7 days during each treatment phase to estimate sleep duration.

TAKEAWAY:

  • Most adolescents (62%) and adults (74%) with T1D reported less than 7 hours of sleep at baseline.
  • Participants with insufficient sleep versus those without insufficient sleep (< 7 vs > 7 hours) had a larger waist circumference and higher mean body mass index, systolic blood pressure, and pulse pressure, as well as lower estimated insulin sensitivity and brachial artery distensibility (P < .05 for all).
  • When stratified by age, only adolescents with T1D with insufficient sleep had significant differences in most health outcomes by sleep duration status, except that adults with less than 7 hours of sleep had higher pulse pressure than those with more than 7 hours of sleep.
  • Compared with placebo, BCQR slightly improved sleeping parameters in adolescents by delaying their time of waking up and prolonging their time in bed.

IN PRACTICE:

“Sleep may be an important and novel target for improving health in individuals with T1D, particularly when initiated in adolescence or early in diabetes,” the authors wrote.

SOURCE:

Stacey L. Simon, PhD, and Janet K. Snell-Bergeon, PhD, University of Colorado Anschutz Medical Campus, Aurora, led this study, which was published online in Diabetes, Obesity and Metabolism.

LIMITATIONS:

The study lacked polysomnography or melatonin assessment to quantify circadian rhythms and subjective sleep quality ratings. It also had no objective measurement of the timing of the daily pills of BCQR, which, when taken in the morning, are hypothesized to reset the circadian rhythm for hypothalamic dopamine and serotonin. The recommended sleep duration of 8 hours for adolescents was not used as the cutoff value due to too few participants who qualified. Also, this study›s findings may be affected by the fact that participants were recruited throughout the year, while adolescents show different sleeping patterns during the academic year compared with school breaks.

 

 

DISCLOSURES:

This work was supported by a JDRF grant. Two authors declared receiving equipment, honoraria for lectures, and support for conference travel, which were all unrelated to this study.

A version of this article appeared on Medscape.com.

 

TOPLINE:

Less than 7 hours of sleep per night is common in individuals with type 1 diabetes (T1D) but is tied to poor cardiometabolic health, particularly in adolescents.

METHODOLOGY:

  • Sleep is recognized as an important factor in diabetes assessment and treatment by the 2023 American Diabetes Association’s Standards of Medical Care in Diabetes, but it is unclear whether sleep may improve health outcomes across the lifespan in patients with T1D.
  • This secondary analysis of the BCQR-T1D crossover trial investigated the link between sleep and cardiometabolic health in 42 adults (age, 19-60 years) and 42 adolescents (age, 12-18 years) with T1D.
  • Participants had T1D duration greater than 9 months and received bromocriptine quick-release (BCQR) therapy or placebo for 4 weeks and then switched between the treatments in a separate 4-week period.
  • They underwent laboratory testing and anthropometric measurements. Also, continuous glucose monitoring data were collected for a week during each treatment phase along with an accompanying insulin dosing diary.
  • Participants were required to wear an actigraphy monitor on the wrist of their nondominant hand for 7 days during each treatment phase to estimate sleep duration.

TAKEAWAY:

  • Most adolescents (62%) and adults (74%) with T1D reported less than 7 hours of sleep at baseline.
  • Participants with insufficient sleep versus those without insufficient sleep (< 7 vs > 7 hours) had a larger waist circumference and higher mean body mass index, systolic blood pressure, and pulse pressure, as well as lower estimated insulin sensitivity and brachial artery distensibility (P < .05 for all).
  • When stratified by age, only adolescents with T1D with insufficient sleep had significant differences in most health outcomes by sleep duration status, except that adults with less than 7 hours of sleep had higher pulse pressure than those with more than 7 hours of sleep.
  • Compared with placebo, BCQR slightly improved sleeping parameters in adolescents by delaying their time of waking up and prolonging their time in bed.

IN PRACTICE:

“Sleep may be an important and novel target for improving health in individuals with T1D, particularly when initiated in adolescence or early in diabetes,” the authors wrote.

SOURCE:

Stacey L. Simon, PhD, and Janet K. Snell-Bergeon, PhD, University of Colorado Anschutz Medical Campus, Aurora, led this study, which was published online in Diabetes, Obesity and Metabolism.

LIMITATIONS:

The study lacked polysomnography or melatonin assessment to quantify circadian rhythms and subjective sleep quality ratings. It also had no objective measurement of the timing of the daily pills of BCQR, which, when taken in the morning, are hypothesized to reset the circadian rhythm for hypothalamic dopamine and serotonin. The recommended sleep duration of 8 hours for adolescents was not used as the cutoff value due to too few participants who qualified. Also, this study›s findings may be affected by the fact that participants were recruited throughout the year, while adolescents show different sleeping patterns during the academic year compared with school breaks.

 

 

DISCLOSURES:

This work was supported by a JDRF grant. Two authors declared receiving equipment, honoraria for lectures, and support for conference travel, which were all unrelated to this study.

A version of this article appeared on Medscape.com.

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Mandibular Device Comparable to CPAP to Reduce BP in Hypertension, OSA

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Changed
Tue, 04/16/2024 - 07:41

Use of a mandibular advancement device (MAD) proved non-inferior to guideline-recommended continuous positive airway pressure (CPAP) to reduce blood pressure in patients with hypertension and obstructive sleep apnea (OSA), in a randomized trial.

The investigator-initiated CRESCENT trial showed that at 6 months, the MAD group had a reduction of 2.5 mm Hg in 24-hour mean arterial blood pressure vs no change in the CPAP group, for a nonsignificant between-group difference of 1.6 mm Hg. 

“These findings suggest that MAD could be considered an alternative to CPAP for optimizing blood pressure control in OSA patients with hypertension and high cardiovascular risk,” the researchers conclude. 

“Looking at the totality of evidence available in the literature, it is still reasonable to say that CPAP is the first-line treatment until we have more data on the MAD,” said Ronald Lee Chi-Hang, MD, professor of medicine at Yong Loo Lin School of Medicine, National University of Singapore, who presented the results.

“However, for patients who truly cannot tolerate or accept using a CPAP, we should be more open-minded in looking for an alternative therapy such as a MAD, which based on our study, numerically had a better blood pressure reduction in patients compared with a CPAP,” said Dr. Chi-Hang, who is also a senior consultant in the Department of Cardiology at Singapore’s National University Heart Centre. 

The results were presented April 6 at the American College of Cardiology Scientific Sessions 2024 and published online simultaneously in the Journal of the American College of Cardiology
 

Oral Appliance

OSA is increasingly recognized as “an underdiagnosed and modifiable cause of hypertension,” the researchers note in their report. “Patients with OSA develop recurrent collapse of the upper airway during sleep, resulting in hypoxemia, sympathetic hyperactivity, and BP surges.” 

Current guidelines recommend screening and treatment of OSA in patients with hypertension, and CPAP is considered first-line therapy, they note. 

“Despite being effective, unfortunately, many patients decline to use a CPAP or find it challenging to stick to the therapy,” Dr. Chi-Hang said, particularly those without daytime sleepiness. 

MADs are oral appliances that work by advancing the mandible about 5 to 10 mm during sleep, he said. They provide an alternative to OSA patients and have been shown to improve daytime sleepiness and quality of life, “and in general, is better accepted and tolerated than CPAP.” 

However, early studies are small, with short follow up, included patients with and without hypertension, and didn’t specify BP reduction as the primary outcome. 

The CRESCENT trial was an investigator-initiated, randomized, non-inferiority trial that aimed to compare the relative effectiveness of MAD vs CPAP in reducing 24-hour ambulatory blood pressure in patients with moderate-to-severe OSA, hypertension and high cardiovascular risk. The prespecified margin for non-inferiority was 1.5 mm Hg. 

A total of 321 participants were recruited at three public hospitals for polysomnography. All were older than age 40 years, had hypertension, and were at increased cardiovascular risk. Of these, 220 with moderate-to-severe OSA, defined as an apnea–hypopnea index (AHI) of ≥ 15 events/hour, were randomly assigned to either MAD or CPAP treatment. 

The primary outcome was the difference between the 24-hour mean arterial BP at baseline and 6 months. The median age was 61 years, most patients (85.5%) were male, and all were Chinese. All had essential hypertension and were on one or more antihypertensive medications. Hypertension was relatively well controlled at baseline.

At 6 months, 24-hour mean arterial BP decreased by 2.5 mm Hg in the MAD group (= .003) compared to no change from baseline in the CPAP group (P = .374). 

The between-group difference was -1.6 mm Hg (95% CI, -3.51 to 0.24, non-inferiority P < .001). 

There was a larger between-group reduction in all secondary ambulatory BP parameters in the MAD versus the CPAP group, with the most pronounced effects seen in the asleep BP parameters. 

Both the MAD and CPAP significantly improved daytime sleepiness, with no between-group differences (P =.384). There were no between-group differences in cardiovascular biomarkers. 

During the presentation, panel discussant Julie B. Damp, MD, associate professor of medicine at Vanderbilt Health in Nashville, Tennessee, called CRESCENT “a really interesting study, and I think it has a lot of information to add [regarding] what we know about this comparison in the literature, because this is a big study and it also followed these patients for longer than we’ve seen in some of the previous studies.”

Dr. Damp asked, however, about how these results might be extrapolated to other populations, since the vast majority of participants were male. 

Dr. Chi-Hang pointed out that most OSA studies include mostly male patients, but noted that particularly in Asian culture, female patients may be more conservative in seeking treatment for problems with snoring, poor quality of sleep, or extensive daytime sleepiness. “Therefore, lots of times, even in clinical practice, we see that over 80 or 90% of patients are male patients,” he said. 

Dr. Damp followed up by asking about the differential effectiveness of CPAP vs MAD. “Just in thinking about these two therapies, there is some evidence that the mandibular devices are potentially less effective on some of the sleep apnea-specific measures, so how much of this do you think is an issue of a better vs a not better treatment as opposed to an issue truly of compliance and what patients are able to tolerate?”

Dr. Chi-Hang agreed that in terms of reducing the AHI, CPAP is more effective than MAD. “In fact, in our data, the residual AHI was 10 for the MAD group and 2 for the CPAP group. Clearly, CPAP is more effective,” he said. “But the problem we are facing in this area is the value of AHI as an index is being questioned.” 

AHI considers only the number of events, without taking into account the duration or the depth of the apnea, he said. “AHI is simply not an ideal index to document the disease severity,” or the impact on cardiovascular outcomes. 
 

 

 

A Tailored Approach

In an editorial accompanying the JACC publication, Michele Emdin, MD, PhD, Francesco Gentile, MD, and Alberto Giannoni, MD, PhD, all from the Health Science Interdisciplinary Center, Scuola Superiore Sant’ Anna, and Fondazione Toscana Gabriele Monasterio, in Pisa, Italy, commend the researchers for designing and conducting “such a pragmatic and informative trial, which confirms and extends previous findings.” 

They also discuss the compliance vs effectiveness issue, pointing out that although CPAP appeared to be more effective in reducing apnea burden, there was higher adherence to MAD — with 57% using the device 6 or more hours per night, vs 23% for CPAP — which might have offset the greater reduction in apnea burden and resulted in the reduction in blood pressure seen in the trial. 

“Addressing poor adherence to OSA treatments seems therefore necessary, particularly in the case of less symptomatic patients, who often have a lower perception of the related risks,” they write. 

“Currently, a tailored approach seems reasonable, based on updated evidence, considering: a) the differential effects of CPAP or MAD on OSA, blood pressure; b) the treatment feasibility; c) the individual baseline demographic and clinical characteristics, including the presence of resistant hypertension; and d) compliance with the therapeutic tool and patient’s preferences,” the editorialists conclude. 

The study was funded by the Singapore Ministry of Health. The authors and editorialists report no relevant financial relationships.

A version of this article appeared on Medscape.com.

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Use of a mandibular advancement device (MAD) proved non-inferior to guideline-recommended continuous positive airway pressure (CPAP) to reduce blood pressure in patients with hypertension and obstructive sleep apnea (OSA), in a randomized trial.

The investigator-initiated CRESCENT trial showed that at 6 months, the MAD group had a reduction of 2.5 mm Hg in 24-hour mean arterial blood pressure vs no change in the CPAP group, for a nonsignificant between-group difference of 1.6 mm Hg. 

“These findings suggest that MAD could be considered an alternative to CPAP for optimizing blood pressure control in OSA patients with hypertension and high cardiovascular risk,” the researchers conclude. 

“Looking at the totality of evidence available in the literature, it is still reasonable to say that CPAP is the first-line treatment until we have more data on the MAD,” said Ronald Lee Chi-Hang, MD, professor of medicine at Yong Loo Lin School of Medicine, National University of Singapore, who presented the results.

“However, for patients who truly cannot tolerate or accept using a CPAP, we should be more open-minded in looking for an alternative therapy such as a MAD, which based on our study, numerically had a better blood pressure reduction in patients compared with a CPAP,” said Dr. Chi-Hang, who is also a senior consultant in the Department of Cardiology at Singapore’s National University Heart Centre. 

The results were presented April 6 at the American College of Cardiology Scientific Sessions 2024 and published online simultaneously in the Journal of the American College of Cardiology
 

Oral Appliance

OSA is increasingly recognized as “an underdiagnosed and modifiable cause of hypertension,” the researchers note in their report. “Patients with OSA develop recurrent collapse of the upper airway during sleep, resulting in hypoxemia, sympathetic hyperactivity, and BP surges.” 

Current guidelines recommend screening and treatment of OSA in patients with hypertension, and CPAP is considered first-line therapy, they note. 

“Despite being effective, unfortunately, many patients decline to use a CPAP or find it challenging to stick to the therapy,” Dr. Chi-Hang said, particularly those without daytime sleepiness. 

MADs are oral appliances that work by advancing the mandible about 5 to 10 mm during sleep, he said. They provide an alternative to OSA patients and have been shown to improve daytime sleepiness and quality of life, “and in general, is better accepted and tolerated than CPAP.” 

However, early studies are small, with short follow up, included patients with and without hypertension, and didn’t specify BP reduction as the primary outcome. 

The CRESCENT trial was an investigator-initiated, randomized, non-inferiority trial that aimed to compare the relative effectiveness of MAD vs CPAP in reducing 24-hour ambulatory blood pressure in patients with moderate-to-severe OSA, hypertension and high cardiovascular risk. The prespecified margin for non-inferiority was 1.5 mm Hg. 

A total of 321 participants were recruited at three public hospitals for polysomnography. All were older than age 40 years, had hypertension, and were at increased cardiovascular risk. Of these, 220 with moderate-to-severe OSA, defined as an apnea–hypopnea index (AHI) of ≥ 15 events/hour, were randomly assigned to either MAD or CPAP treatment. 

The primary outcome was the difference between the 24-hour mean arterial BP at baseline and 6 months. The median age was 61 years, most patients (85.5%) were male, and all were Chinese. All had essential hypertension and were on one or more antihypertensive medications. Hypertension was relatively well controlled at baseline.

At 6 months, 24-hour mean arterial BP decreased by 2.5 mm Hg in the MAD group (= .003) compared to no change from baseline in the CPAP group (P = .374). 

The between-group difference was -1.6 mm Hg (95% CI, -3.51 to 0.24, non-inferiority P < .001). 

There was a larger between-group reduction in all secondary ambulatory BP parameters in the MAD versus the CPAP group, with the most pronounced effects seen in the asleep BP parameters. 

Both the MAD and CPAP significantly improved daytime sleepiness, with no between-group differences (P =.384). There were no between-group differences in cardiovascular biomarkers. 

During the presentation, panel discussant Julie B. Damp, MD, associate professor of medicine at Vanderbilt Health in Nashville, Tennessee, called CRESCENT “a really interesting study, and I think it has a lot of information to add [regarding] what we know about this comparison in the literature, because this is a big study and it also followed these patients for longer than we’ve seen in some of the previous studies.”

Dr. Damp asked, however, about how these results might be extrapolated to other populations, since the vast majority of participants were male. 

Dr. Chi-Hang pointed out that most OSA studies include mostly male patients, but noted that particularly in Asian culture, female patients may be more conservative in seeking treatment for problems with snoring, poor quality of sleep, or extensive daytime sleepiness. “Therefore, lots of times, even in clinical practice, we see that over 80 or 90% of patients are male patients,” he said. 

Dr. Damp followed up by asking about the differential effectiveness of CPAP vs MAD. “Just in thinking about these two therapies, there is some evidence that the mandibular devices are potentially less effective on some of the sleep apnea-specific measures, so how much of this do you think is an issue of a better vs a not better treatment as opposed to an issue truly of compliance and what patients are able to tolerate?”

Dr. Chi-Hang agreed that in terms of reducing the AHI, CPAP is more effective than MAD. “In fact, in our data, the residual AHI was 10 for the MAD group and 2 for the CPAP group. Clearly, CPAP is more effective,” he said. “But the problem we are facing in this area is the value of AHI as an index is being questioned.” 

AHI considers only the number of events, without taking into account the duration or the depth of the apnea, he said. “AHI is simply not an ideal index to document the disease severity,” or the impact on cardiovascular outcomes. 
 

 

 

A Tailored Approach

In an editorial accompanying the JACC publication, Michele Emdin, MD, PhD, Francesco Gentile, MD, and Alberto Giannoni, MD, PhD, all from the Health Science Interdisciplinary Center, Scuola Superiore Sant’ Anna, and Fondazione Toscana Gabriele Monasterio, in Pisa, Italy, commend the researchers for designing and conducting “such a pragmatic and informative trial, which confirms and extends previous findings.” 

They also discuss the compliance vs effectiveness issue, pointing out that although CPAP appeared to be more effective in reducing apnea burden, there was higher adherence to MAD — with 57% using the device 6 or more hours per night, vs 23% for CPAP — which might have offset the greater reduction in apnea burden and resulted in the reduction in blood pressure seen in the trial. 

“Addressing poor adherence to OSA treatments seems therefore necessary, particularly in the case of less symptomatic patients, who often have a lower perception of the related risks,” they write. 

“Currently, a tailored approach seems reasonable, based on updated evidence, considering: a) the differential effects of CPAP or MAD on OSA, blood pressure; b) the treatment feasibility; c) the individual baseline demographic and clinical characteristics, including the presence of resistant hypertension; and d) compliance with the therapeutic tool and patient’s preferences,” the editorialists conclude. 

The study was funded by the Singapore Ministry of Health. The authors and editorialists report no relevant financial relationships.

A version of this article appeared on Medscape.com.

Use of a mandibular advancement device (MAD) proved non-inferior to guideline-recommended continuous positive airway pressure (CPAP) to reduce blood pressure in patients with hypertension and obstructive sleep apnea (OSA), in a randomized trial.

The investigator-initiated CRESCENT trial showed that at 6 months, the MAD group had a reduction of 2.5 mm Hg in 24-hour mean arterial blood pressure vs no change in the CPAP group, for a nonsignificant between-group difference of 1.6 mm Hg. 

“These findings suggest that MAD could be considered an alternative to CPAP for optimizing blood pressure control in OSA patients with hypertension and high cardiovascular risk,” the researchers conclude. 

“Looking at the totality of evidence available in the literature, it is still reasonable to say that CPAP is the first-line treatment until we have more data on the MAD,” said Ronald Lee Chi-Hang, MD, professor of medicine at Yong Loo Lin School of Medicine, National University of Singapore, who presented the results.

“However, for patients who truly cannot tolerate or accept using a CPAP, we should be more open-minded in looking for an alternative therapy such as a MAD, which based on our study, numerically had a better blood pressure reduction in patients compared with a CPAP,” said Dr. Chi-Hang, who is also a senior consultant in the Department of Cardiology at Singapore’s National University Heart Centre. 

The results were presented April 6 at the American College of Cardiology Scientific Sessions 2024 and published online simultaneously in the Journal of the American College of Cardiology
 

Oral Appliance

OSA is increasingly recognized as “an underdiagnosed and modifiable cause of hypertension,” the researchers note in their report. “Patients with OSA develop recurrent collapse of the upper airway during sleep, resulting in hypoxemia, sympathetic hyperactivity, and BP surges.” 

Current guidelines recommend screening and treatment of OSA in patients with hypertension, and CPAP is considered first-line therapy, they note. 

“Despite being effective, unfortunately, many patients decline to use a CPAP or find it challenging to stick to the therapy,” Dr. Chi-Hang said, particularly those without daytime sleepiness. 

MADs are oral appliances that work by advancing the mandible about 5 to 10 mm during sleep, he said. They provide an alternative to OSA patients and have been shown to improve daytime sleepiness and quality of life, “and in general, is better accepted and tolerated than CPAP.” 

However, early studies are small, with short follow up, included patients with and without hypertension, and didn’t specify BP reduction as the primary outcome. 

The CRESCENT trial was an investigator-initiated, randomized, non-inferiority trial that aimed to compare the relative effectiveness of MAD vs CPAP in reducing 24-hour ambulatory blood pressure in patients with moderate-to-severe OSA, hypertension and high cardiovascular risk. The prespecified margin for non-inferiority was 1.5 mm Hg. 

A total of 321 participants were recruited at three public hospitals for polysomnography. All were older than age 40 years, had hypertension, and were at increased cardiovascular risk. Of these, 220 with moderate-to-severe OSA, defined as an apnea–hypopnea index (AHI) of ≥ 15 events/hour, were randomly assigned to either MAD or CPAP treatment. 

The primary outcome was the difference between the 24-hour mean arterial BP at baseline and 6 months. The median age was 61 years, most patients (85.5%) were male, and all were Chinese. All had essential hypertension and were on one or more antihypertensive medications. Hypertension was relatively well controlled at baseline.

At 6 months, 24-hour mean arterial BP decreased by 2.5 mm Hg in the MAD group (= .003) compared to no change from baseline in the CPAP group (P = .374). 

The between-group difference was -1.6 mm Hg (95% CI, -3.51 to 0.24, non-inferiority P < .001). 

There was a larger between-group reduction in all secondary ambulatory BP parameters in the MAD versus the CPAP group, with the most pronounced effects seen in the asleep BP parameters. 

Both the MAD and CPAP significantly improved daytime sleepiness, with no between-group differences (P =.384). There were no between-group differences in cardiovascular biomarkers. 

During the presentation, panel discussant Julie B. Damp, MD, associate professor of medicine at Vanderbilt Health in Nashville, Tennessee, called CRESCENT “a really interesting study, and I think it has a lot of information to add [regarding] what we know about this comparison in the literature, because this is a big study and it also followed these patients for longer than we’ve seen in some of the previous studies.”

Dr. Damp asked, however, about how these results might be extrapolated to other populations, since the vast majority of participants were male. 

Dr. Chi-Hang pointed out that most OSA studies include mostly male patients, but noted that particularly in Asian culture, female patients may be more conservative in seeking treatment for problems with snoring, poor quality of sleep, or extensive daytime sleepiness. “Therefore, lots of times, even in clinical practice, we see that over 80 or 90% of patients are male patients,” he said. 

Dr. Damp followed up by asking about the differential effectiveness of CPAP vs MAD. “Just in thinking about these two therapies, there is some evidence that the mandibular devices are potentially less effective on some of the sleep apnea-specific measures, so how much of this do you think is an issue of a better vs a not better treatment as opposed to an issue truly of compliance and what patients are able to tolerate?”

Dr. Chi-Hang agreed that in terms of reducing the AHI, CPAP is more effective than MAD. “In fact, in our data, the residual AHI was 10 for the MAD group and 2 for the CPAP group. Clearly, CPAP is more effective,” he said. “But the problem we are facing in this area is the value of AHI as an index is being questioned.” 

AHI considers only the number of events, without taking into account the duration or the depth of the apnea, he said. “AHI is simply not an ideal index to document the disease severity,” or the impact on cardiovascular outcomes. 
 

 

 

A Tailored Approach

In an editorial accompanying the JACC publication, Michele Emdin, MD, PhD, Francesco Gentile, MD, and Alberto Giannoni, MD, PhD, all from the Health Science Interdisciplinary Center, Scuola Superiore Sant’ Anna, and Fondazione Toscana Gabriele Monasterio, in Pisa, Italy, commend the researchers for designing and conducting “such a pragmatic and informative trial, which confirms and extends previous findings.” 

They also discuss the compliance vs effectiveness issue, pointing out that although CPAP appeared to be more effective in reducing apnea burden, there was higher adherence to MAD — with 57% using the device 6 or more hours per night, vs 23% for CPAP — which might have offset the greater reduction in apnea burden and resulted in the reduction in blood pressure seen in the trial. 

“Addressing poor adherence to OSA treatments seems therefore necessary, particularly in the case of less symptomatic patients, who often have a lower perception of the related risks,” they write. 

“Currently, a tailored approach seems reasonable, based on updated evidence, considering: a) the differential effects of CPAP or MAD on OSA, blood pressure; b) the treatment feasibility; c) the individual baseline demographic and clinical characteristics, including the presence of resistant hypertension; and d) compliance with the therapeutic tool and patient’s preferences,” the editorialists conclude. 

The study was funded by the Singapore Ministry of Health. The authors and editorialists report no relevant financial relationships.

A version of this article appeared on Medscape.com.

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Nasal Cannula Dislodgement During Sleep in Veterans Receiving Long-term Oxygen Therapy for Hypoxemic Chronic Respiratory Failure

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Wed, 04/10/2024 - 16:42

The prevalence of chronic obstructive pulmonary disease (COPD) among male US veterans is higher than in the general population.1 Veterans with COPD have higher rates of comorbidities and increased respiratory-related and all-cause health care use, including the use of long-term oxygen therapy (LTOT).2-5 It has been well established that LTOT reduces all-cause mortality in patients with COPD and resting hypoxemic chronic respiratory failure (CRF) when used for ≥ 15 hours per day.6-8

Delivery of domiciliary LTOT entails placing a nasal cannula into both nostrils and loosely securing it around both ears throughout the wake-sleep cycle. Several veterans with hypoxemic CRF due to COPD at the Jesse Brown Veterans Affairs Medical Center (JBVAMC) in Chicago, Illinois, who were receiving LTOT reported nasal cannula dislodgement (NCD) while they slept. However, the clinical significance and impact of these repeated episodes on respiratory-related health care utilization, such as frequent COPD exacerbations with hospitalization, were not recognized. Moreover, we found no published reports or clinical practice guidelines alluding to similar events reported by patients with hypoxemic CRF due to COPD receiving LTOT either at home or in an acute care setting.8,9 Nonetheless, frequent COPD exacerbations are associated with increased hospital admissions and account for a large portion of health care costs attributed to COPD.10-13

The purpose of this study was to determine whether veterans with hypoxemic CRF due to COPD and receiving 24-hour LTOT at JBVAMC were experiencing NCD during sleep and, if so, its impact on their hospitalizations for COPD exacerbations.

METHODS

We reviewed electronic health records (EHRs) of veterans with hypoxemic CRF from COPD who received 24-hour LTOT administered through nasal cannula and were followed in the JBVAMC pulmonary outpatient clinic between February 1, 2022, and December 31, 2022. In each case, LTOT was prescribed by a board-certified pulmonologist based on Veterans Health Administration clinical practice guidelines.14 A licensed durable medical equipment company contracted by the JBVAMC delivered and established home oxygen equipment at each veteran’s residence.

Pertinent patient demographics, clinical and physiologic variables, and hospitalizations with length of JBVAMC stay for each physician-diagnosed COPD exacerbation in the preceding year from the date last seen in the clinic were abstracted from EHRs. Overall hospital cost, defined as a veteran overnight stay in either the medical intensive care unit (MICU) or a general acute medicine bed in a US Department of Veterans Affairs (VA) facility, was calculated for each hospitalization for physician-diagnosed COPD exacerbation using VA Managerial Cost Accounting System National Cost Extracts for inpatient encounters.15 We then contacted each veteran by telephone and asked whether they had experienced NCD and, if so, its weekly frequency ranging from once to nightly.

Data Analysis

Data were reported as mean (SD) where appropriate. The t test and Fisher exact test were used as indicated. P < .05 was considered statistically significant. The study protocol was determined to be exempt by the JBVAMC Institutional Review Board (Protocol #1725748).

 

 

RESULTS

table 1

During the study period, 75 patients with hypoxemic CRF from COPD received LTOT and were followed at the JBVAMC. No patients were hospitalized outside the JBVAMC for COPD exacerbation during this time frame. We also found no documentation in the EHRs indicating that the clinicians managing these patients at the JBVAMC inquired about NCD during sleep.

figure

Of the 75 patients, 66 (88%) responded to the telephone survey and 22 patients (33%) reported weekly episodes of NCD while they slept (median, 4 dislodgments per week). (Table 1). Eight patients (36%) reported nightly NCDs (Figure). All 66 respondents were male and 14 of 22 in the NCD group as well as 21 of 44 in the no NCD group were Black veterans. The mean age was similar in both groups: 71 years in the NCD group and 72 years in the no NCD group. There were no statistically significant differences in demographics, including prevalence of obstructive sleep apnea (OSA), supplemental oxygen flow rate, and duration of LTOT, or in pulmonary function test results between patients who did and did not experience NCD while sleeping (Table 2).

table 3
table 2

Ten of 22 patients (45%) with NCD and 9 of 44 patients (20%) without NCD were hospitalized at the JBVAMC for ≥ 1 COPD exacerbation in the preceding year that was diagnosed by a physician (P = .045). Three of 22 patients (14%) with NCD and no patients in the no NCD group were admitted to the MICU. No patients required intubation and mechanical ventilation during hospitalization, and no patients died. Overall hospital costs were 25% ($64,342) higher in NCD group compared with the no NCD group and were attributed to the MICU admissions in the NCD group (Table 3). Nine veterans did not respond to repeated telephone calls. One physician-diagnosed COPD exacerbation requiring hospitalization was documented in the nonresponder group; the patient was hospitalized for 2 days. One veteran died before being contacted.

 

 

DISCUSSION

There are 3 new findings in this study. First, health care practitioners at JBVAMC did not document the presence of NCD during sleep in patients with hypoxemic CRF due to COPD and receiving LTOT. Second, one-third of these patients reported frequent NCD during sleep when interviewed. Third, the nocturnal events were associated with a higher hospitalization rate for physician-diagnosed COPD exacerbation and higher overall hospital costs. These findings are unlikely to be explained by differences in COPD severity and/or known triggers that lead to COPD exacerbation and require hospitalization because baseline physiologic and LTOT parameters were similar in both groups. Conceivably, patients with untreated OSA could be restless while asleep, leading to NCD. However, this explanation seems unlikely because the frequency of OSA was similar in both groups.

Nocturnal arterial oxygen desaturation in patients with COPD without evidence of OSA may contribute to the frequency of exacerbations.16 Although the mechanism(s) underlying this phenomenon is uncertain, we posit that prolonged nocturnal airway wall hypoxia could amplify underlying chronic inflammation through local generation of reactive oxygen species, thereby predisposing patients to exacerbations. Frequent COPD exacerbations promote disease progression and health status decline and are associated with increased mortality.11,13 Moreover, hospitalization of patients with COPD is the largest contributor to the annual direct cost of COPD per patient.10,12 The higher hospitalization rate observed in the NCD group in our study suggests that interruption of supplemental oxygen delivery while asleep may be a risk factor for COPD exacerbation. Alternatively, an independent factor or factors may have contributed to both NCD during sleep and COPD exacerbation in these patients or an impending exacerbation resulted in sleep disturbances that led to NCD. Additional research is warranted on veterans with hypoxemic CRF from COPD who are receiving LTOT and report frequent NCD during sleep that may support or refute these hypotheses.

To the best of our knowledge, NCD during sleep has not been previously reported in patients with hypoxemic CRF due to COPD who are receiving LTOT at home or in an acute care setting.17-20 Several layperson proposals to secure nasal cannulas to the face while sleeping are posted online. These include wearing a commercially available headband with 2 Velcro loops that fix the cannula tube, using fabric medical tape on both cheeks, and wearing a sleep mask. Conceivably, the efficacy and safety of these inexpensive interventions to mitigate NCD during sleep in patients receiving LTOT with hypoxemic CRF from COPD could be tested in clinical trials.

Limitations

This was a small, single-site study, comprised entirely of male patients who are predominantly Black veterans. The telephone interviews with veterans self-reporting NCD during their sleep are prone to recall bias. In addition, the validity and reproducibility of NCD during sleep were not addressed in this study. Missing data from 9 nonresponders may have introduced a nonresponse bias in data analysis and interpretation. The overall hospital cost for a COPD exacerbation at JBVAMC was derived from VA data; US Centers for Medicare & Medicaid Services or commercial carrier data may be different.15,21 Lastly, access to LTOT for veterans with hypoxemic CRF from COPD is regulated and supervised at VA medical facilities.14 This process may be different for patients outside the VA. Taken together, it is difficult to generalize our initial observations to non-VA patients with hypoxemic CRF from COPD who are receiving LTOT. We suggest a large, prospective study of veterans be conducted to determine the prevalence of NCD during sleep and its relationship with COPD exacerbations in veterans receiving LTOT with hypoxemic CRF due to COPD.

CONCLUSIONS

Clinicians at the JBVAMC did not document the presence of NCD during sleep in patients with hypoxemic CRF from COPD who received LTOT. However, self-reported, weekly nocturnal NCD episodes were associated with a higher hospitalization rate for COPD exacerbation and higher hospital costs. Accordingly, user-friendly devices to mitigate NCD during sleep should be developed.

Acknowledgments

We thank Yolanda Davis, RRT, and George Adam for their assistance with this project.

References

1. Boersma P, Cohen RA, Zelaya CE, Moy E. Multiple chronic conditions among veterans and nonveterans: United States, 2015-2018. Natl Health Stat Report. 2021;(153):1-13. doi:10.15620/cdc:101659

2. Sharafkhaneh A, Petersen NJ, Yu H-J, Dalal AA, Johnson ML, Hanania NA. Burden of COPD in a government health care system: a retrospective observational study using data from the US Veterans Affairs population. Int J Chron Obstruct Pulmon Dis. 2010;5:125-132. doi:10.2147/copd.s8047

3. LaBedz SL, Krishnan JA, Chung Y-C, et al. Chronic obstructive pulmonary disease outcomes at Veterans Affairs versus non-Veterans Affairs hospitals. Chronic Obstr Pulm Dis. 2021;8(3):306-313. doi:10.15326/jcopdf.2021.0201

4. Darnell K, Dwivedi AK, Weng Z, Panos RJ. Disproportionate utilization of healthcare resources among veterans with COPD: a retrospective analysis of factors associated with COPD healthcare cost. Cost Eff Resour Alloc. 2013;11:13. doi:10.1186/1478-7547-11-13

5. Bamonti PM, Robinson SA, Wan ES, Moy ML. Improving physiological, physical, and psychological health outcomes: a narrative review in US Veterans with COPD. Int J Chron Obstruct Pulmon Dis. 2022;17:1269-1283. doi:10.2147/COPD.S339323

6. Cranston JM, Crockett AJ, Moss JR, Alpers JH. Domiciliary oxygen for chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2005;2005(4):CD001744. doi:10.1002/14651858.CD001744.pub2

7. Lacasse Y, Tan AM, Maltais F, Krishnan JA. Home oxygen in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2018;197(10):1254-1264. doi:10.1164/rccm.201802-0382CI

8. Jacobs SS, Krishnan JA, Lederer DJ, et al. Home oxygen therapy for adults with chronic lung disease. An official American Thoracic Society Clinical Practice Guideline. Am J Respir Crit Care Med. 2020;202(10):e121-e141. doi:10.1164/rccm.202009-3608ST

9. AARC. AARC clinical practice guideline. Oxygen therapy in the home or alternate site health care facility--2007 revision & update. Respir Care. 2007;52(8):1063-1068.

10. Foo J, Landis SH, Maskell J, et al. Continuing to confront COPD international patient survey: economic impact of COPD in 12 countries. PLoS One. 2016;11(4):e0152618. doi:10.1371/journal.pone.0152618

11. Rothnie KJ, Müllerová H, Smeeth L, Quint JK. Natural history of chronic obstructive pulmonary disease exacerbations in a general practice-based population with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2018;198(4):464-471. doi:10.1164/rccm.201710-2029OC

12. Stanford RH, Engel-Nitz NM, Bancroft T, Essoi B. The identification and cost of acute chronic obstructive pulmonary disease exacerbations in a United States population healthcare claims database. COPD. 2020;17(5):499-508. doi:10.1080/15412555.2020.1817357

13. Hurst JR, Han MK, Singh B, et al. Prognostic risk factors for moderate-to-severe exacerbations in patients with chronic obstructive pulmonary disease: a systematic literature review. Respir Res. 2022;23(1):213. doi:10.1186/s12931-022-02123-5

14. US Department of Veterans Affairs, Veterans Health Administration. Home oxygen program. VHA Directive 1173.13(1). Published August 5, 2020. Accessed February 28, 2024. https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=8947

15. Phibbs CS, Barnett PG, Fan A, Harden C, King SS, Scott JY. Research guide to decision support system national cost extracts. Health Economics Resource Center of Health Service R&D Services, US Department of Veterans Affairs. September 2010. Accessed February 14, 2024. https://www.herc.research.va.gov/files/book_621.pdf

16. Agusti A, Hedner J, Marin JM, Barbé F, Cazzola M, Rennard S. Night-time symptoms: a forgotten dimension of COPD. Eur Respir Rev. 2011;20(121):183-194. doi:10.1183/09059180.00004311

17. Croxton TL, Bailey WC. Long-term oxygen treatment in chronic obstructive pulmonary disease: recommendations for future research: an NHLBI workshop report. Am J Respir Crit Care Med. 2006;174(4):373-378. doi:10.1164/rccm.200507-1161WS

18. Melani AS, Sestini P, Rottoli P. Home oxygen therapy: re-thinking the role of devices. Expert Rev Clin Pharmacol. 2018;11(3):279-289. doi:10.1080/17512433.2018.1421457

19. Sculley JA, Corbridge SJ, Prieto-Centurion V, et al. Home oxygen therapy for patients with COPD: time for a reboot. Respir Care. 2019;64(12):1574-1585. doi:10.4187/respcare.07135

20. Jacobs SS, Lindell KO, Collins EG, et al. Patient perceptions of the adequacy of supplemental oxygen therapy. Results of the American Thoracic Society Nursing Assembly Oxygen Working Group Survey. Ann Am Thorac Soc. 2018;15:24-32. doi:10.1513/AnnalsATS.201703-209OC

21. US Centers for Medicare & Medicaid Services. Home use of oxygen. Publication number 100-3. January 3, 2023. Accessed February 14, 2024. https://www.cms.gov/medicare-coverage-database/view/ncd.aspx?NCDId=169

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Zane Elfessi, PharmD, BCPS, BCCCPa,b; Ahmed Mahgoub, MDa; Emily Tran, PharmDa,b; Grace McGeeb; Israel Rubinstein, MDa,b

Correspondence:  Israel Rubinstein ([email protected])

aJesse Brown Veterans Affairs Medical Center, Chicago, Illinois

bUniversity of Illinois Chicago College of Pharmacy

Author roles

All authors were involved in the conception, study design, data acquisition, analysis, writing, and editing of the manuscript.

Disclosures

This material is the result of work supported with resources and the use of facilities at the Jesse Brown Veterans Affairs Medical Center. The authors report no actual or potential conflicts of interest or outside sources of funding with regard to this article.

Disclaimer

The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies.

Ethics and consent

The study protocol was determined to be exempt by Jesse Brown Veterans Affairs Medical Center Institutional Review Board (Protocol #1725748).

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Author and Disclosure Information

Zane Elfessi, PharmD, BCPS, BCCCPa,b; Ahmed Mahgoub, MDa; Emily Tran, PharmDa,b; Grace McGeeb; Israel Rubinstein, MDa,b

Correspondence:  Israel Rubinstein ([email protected])

aJesse Brown Veterans Affairs Medical Center, Chicago, Illinois

bUniversity of Illinois Chicago College of Pharmacy

Author roles

All authors were involved in the conception, study design, data acquisition, analysis, writing, and editing of the manuscript.

Disclosures

This material is the result of work supported with resources and the use of facilities at the Jesse Brown Veterans Affairs Medical Center. The authors report no actual or potential conflicts of interest or outside sources of funding with regard to this article.

Disclaimer

The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies.

Ethics and consent

The study protocol was determined to be exempt by Jesse Brown Veterans Affairs Medical Center Institutional Review Board (Protocol #1725748).

Author and Disclosure Information

Zane Elfessi, PharmD, BCPS, BCCCPa,b; Ahmed Mahgoub, MDa; Emily Tran, PharmDa,b; Grace McGeeb; Israel Rubinstein, MDa,b

Correspondence:  Israel Rubinstein ([email protected])

aJesse Brown Veterans Affairs Medical Center, Chicago, Illinois

bUniversity of Illinois Chicago College of Pharmacy

Author roles

All authors were involved in the conception, study design, data acquisition, analysis, writing, and editing of the manuscript.

Disclosures

This material is the result of work supported with resources and the use of facilities at the Jesse Brown Veterans Affairs Medical Center. The authors report no actual or potential conflicts of interest or outside sources of funding with regard to this article.

Disclaimer

The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the US Government, or any of its agencies.

Ethics and consent

The study protocol was determined to be exempt by Jesse Brown Veterans Affairs Medical Center Institutional Review Board (Protocol #1725748).

Article PDF
Article PDF

The prevalence of chronic obstructive pulmonary disease (COPD) among male US veterans is higher than in the general population.1 Veterans with COPD have higher rates of comorbidities and increased respiratory-related and all-cause health care use, including the use of long-term oxygen therapy (LTOT).2-5 It has been well established that LTOT reduces all-cause mortality in patients with COPD and resting hypoxemic chronic respiratory failure (CRF) when used for ≥ 15 hours per day.6-8

Delivery of domiciliary LTOT entails placing a nasal cannula into both nostrils and loosely securing it around both ears throughout the wake-sleep cycle. Several veterans with hypoxemic CRF due to COPD at the Jesse Brown Veterans Affairs Medical Center (JBVAMC) in Chicago, Illinois, who were receiving LTOT reported nasal cannula dislodgement (NCD) while they slept. However, the clinical significance and impact of these repeated episodes on respiratory-related health care utilization, such as frequent COPD exacerbations with hospitalization, were not recognized. Moreover, we found no published reports or clinical practice guidelines alluding to similar events reported by patients with hypoxemic CRF due to COPD receiving LTOT either at home or in an acute care setting.8,9 Nonetheless, frequent COPD exacerbations are associated with increased hospital admissions and account for a large portion of health care costs attributed to COPD.10-13

The purpose of this study was to determine whether veterans with hypoxemic CRF due to COPD and receiving 24-hour LTOT at JBVAMC were experiencing NCD during sleep and, if so, its impact on their hospitalizations for COPD exacerbations.

METHODS

We reviewed electronic health records (EHRs) of veterans with hypoxemic CRF from COPD who received 24-hour LTOT administered through nasal cannula and were followed in the JBVAMC pulmonary outpatient clinic between February 1, 2022, and December 31, 2022. In each case, LTOT was prescribed by a board-certified pulmonologist based on Veterans Health Administration clinical practice guidelines.14 A licensed durable medical equipment company contracted by the JBVAMC delivered and established home oxygen equipment at each veteran’s residence.

Pertinent patient demographics, clinical and physiologic variables, and hospitalizations with length of JBVAMC stay for each physician-diagnosed COPD exacerbation in the preceding year from the date last seen in the clinic were abstracted from EHRs. Overall hospital cost, defined as a veteran overnight stay in either the medical intensive care unit (MICU) or a general acute medicine bed in a US Department of Veterans Affairs (VA) facility, was calculated for each hospitalization for physician-diagnosed COPD exacerbation using VA Managerial Cost Accounting System National Cost Extracts for inpatient encounters.15 We then contacted each veteran by telephone and asked whether they had experienced NCD and, if so, its weekly frequency ranging from once to nightly.

Data Analysis

Data were reported as mean (SD) where appropriate. The t test and Fisher exact test were used as indicated. P < .05 was considered statistically significant. The study protocol was determined to be exempt by the JBVAMC Institutional Review Board (Protocol #1725748).

 

 

RESULTS

table 1

During the study period, 75 patients with hypoxemic CRF from COPD received LTOT and were followed at the JBVAMC. No patients were hospitalized outside the JBVAMC for COPD exacerbation during this time frame. We also found no documentation in the EHRs indicating that the clinicians managing these patients at the JBVAMC inquired about NCD during sleep.

figure

Of the 75 patients, 66 (88%) responded to the telephone survey and 22 patients (33%) reported weekly episodes of NCD while they slept (median, 4 dislodgments per week). (Table 1). Eight patients (36%) reported nightly NCDs (Figure). All 66 respondents were male and 14 of 22 in the NCD group as well as 21 of 44 in the no NCD group were Black veterans. The mean age was similar in both groups: 71 years in the NCD group and 72 years in the no NCD group. There were no statistically significant differences in demographics, including prevalence of obstructive sleep apnea (OSA), supplemental oxygen flow rate, and duration of LTOT, or in pulmonary function test results between patients who did and did not experience NCD while sleeping (Table 2).

table 3
table 2

Ten of 22 patients (45%) with NCD and 9 of 44 patients (20%) without NCD were hospitalized at the JBVAMC for ≥ 1 COPD exacerbation in the preceding year that was diagnosed by a physician (P = .045). Three of 22 patients (14%) with NCD and no patients in the no NCD group were admitted to the MICU. No patients required intubation and mechanical ventilation during hospitalization, and no patients died. Overall hospital costs were 25% ($64,342) higher in NCD group compared with the no NCD group and were attributed to the MICU admissions in the NCD group (Table 3). Nine veterans did not respond to repeated telephone calls. One physician-diagnosed COPD exacerbation requiring hospitalization was documented in the nonresponder group; the patient was hospitalized for 2 days. One veteran died before being contacted.

 

 

DISCUSSION

There are 3 new findings in this study. First, health care practitioners at JBVAMC did not document the presence of NCD during sleep in patients with hypoxemic CRF due to COPD and receiving LTOT. Second, one-third of these patients reported frequent NCD during sleep when interviewed. Third, the nocturnal events were associated with a higher hospitalization rate for physician-diagnosed COPD exacerbation and higher overall hospital costs. These findings are unlikely to be explained by differences in COPD severity and/or known triggers that lead to COPD exacerbation and require hospitalization because baseline physiologic and LTOT parameters were similar in both groups. Conceivably, patients with untreated OSA could be restless while asleep, leading to NCD. However, this explanation seems unlikely because the frequency of OSA was similar in both groups.

Nocturnal arterial oxygen desaturation in patients with COPD without evidence of OSA may contribute to the frequency of exacerbations.16 Although the mechanism(s) underlying this phenomenon is uncertain, we posit that prolonged nocturnal airway wall hypoxia could amplify underlying chronic inflammation through local generation of reactive oxygen species, thereby predisposing patients to exacerbations. Frequent COPD exacerbations promote disease progression and health status decline and are associated with increased mortality.11,13 Moreover, hospitalization of patients with COPD is the largest contributor to the annual direct cost of COPD per patient.10,12 The higher hospitalization rate observed in the NCD group in our study suggests that interruption of supplemental oxygen delivery while asleep may be a risk factor for COPD exacerbation. Alternatively, an independent factor or factors may have contributed to both NCD during sleep and COPD exacerbation in these patients or an impending exacerbation resulted in sleep disturbances that led to NCD. Additional research is warranted on veterans with hypoxemic CRF from COPD who are receiving LTOT and report frequent NCD during sleep that may support or refute these hypotheses.

To the best of our knowledge, NCD during sleep has not been previously reported in patients with hypoxemic CRF due to COPD who are receiving LTOT at home or in an acute care setting.17-20 Several layperson proposals to secure nasal cannulas to the face while sleeping are posted online. These include wearing a commercially available headband with 2 Velcro loops that fix the cannula tube, using fabric medical tape on both cheeks, and wearing a sleep mask. Conceivably, the efficacy and safety of these inexpensive interventions to mitigate NCD during sleep in patients receiving LTOT with hypoxemic CRF from COPD could be tested in clinical trials.

Limitations

This was a small, single-site study, comprised entirely of male patients who are predominantly Black veterans. The telephone interviews with veterans self-reporting NCD during their sleep are prone to recall bias. In addition, the validity and reproducibility of NCD during sleep were not addressed in this study. Missing data from 9 nonresponders may have introduced a nonresponse bias in data analysis and interpretation. The overall hospital cost for a COPD exacerbation at JBVAMC was derived from VA data; US Centers for Medicare & Medicaid Services or commercial carrier data may be different.15,21 Lastly, access to LTOT for veterans with hypoxemic CRF from COPD is regulated and supervised at VA medical facilities.14 This process may be different for patients outside the VA. Taken together, it is difficult to generalize our initial observations to non-VA patients with hypoxemic CRF from COPD who are receiving LTOT. We suggest a large, prospective study of veterans be conducted to determine the prevalence of NCD during sleep and its relationship with COPD exacerbations in veterans receiving LTOT with hypoxemic CRF due to COPD.

CONCLUSIONS

Clinicians at the JBVAMC did not document the presence of NCD during sleep in patients with hypoxemic CRF from COPD who received LTOT. However, self-reported, weekly nocturnal NCD episodes were associated with a higher hospitalization rate for COPD exacerbation and higher hospital costs. Accordingly, user-friendly devices to mitigate NCD during sleep should be developed.

Acknowledgments

We thank Yolanda Davis, RRT, and George Adam for their assistance with this project.

The prevalence of chronic obstructive pulmonary disease (COPD) among male US veterans is higher than in the general population.1 Veterans with COPD have higher rates of comorbidities and increased respiratory-related and all-cause health care use, including the use of long-term oxygen therapy (LTOT).2-5 It has been well established that LTOT reduces all-cause mortality in patients with COPD and resting hypoxemic chronic respiratory failure (CRF) when used for ≥ 15 hours per day.6-8

Delivery of domiciliary LTOT entails placing a nasal cannula into both nostrils and loosely securing it around both ears throughout the wake-sleep cycle. Several veterans with hypoxemic CRF due to COPD at the Jesse Brown Veterans Affairs Medical Center (JBVAMC) in Chicago, Illinois, who were receiving LTOT reported nasal cannula dislodgement (NCD) while they slept. However, the clinical significance and impact of these repeated episodes on respiratory-related health care utilization, such as frequent COPD exacerbations with hospitalization, were not recognized. Moreover, we found no published reports or clinical practice guidelines alluding to similar events reported by patients with hypoxemic CRF due to COPD receiving LTOT either at home or in an acute care setting.8,9 Nonetheless, frequent COPD exacerbations are associated with increased hospital admissions and account for a large portion of health care costs attributed to COPD.10-13

The purpose of this study was to determine whether veterans with hypoxemic CRF due to COPD and receiving 24-hour LTOT at JBVAMC were experiencing NCD during sleep and, if so, its impact on their hospitalizations for COPD exacerbations.

METHODS

We reviewed electronic health records (EHRs) of veterans with hypoxemic CRF from COPD who received 24-hour LTOT administered through nasal cannula and were followed in the JBVAMC pulmonary outpatient clinic between February 1, 2022, and December 31, 2022. In each case, LTOT was prescribed by a board-certified pulmonologist based on Veterans Health Administration clinical practice guidelines.14 A licensed durable medical equipment company contracted by the JBVAMC delivered and established home oxygen equipment at each veteran’s residence.

Pertinent patient demographics, clinical and physiologic variables, and hospitalizations with length of JBVAMC stay for each physician-diagnosed COPD exacerbation in the preceding year from the date last seen in the clinic were abstracted from EHRs. Overall hospital cost, defined as a veteran overnight stay in either the medical intensive care unit (MICU) or a general acute medicine bed in a US Department of Veterans Affairs (VA) facility, was calculated for each hospitalization for physician-diagnosed COPD exacerbation using VA Managerial Cost Accounting System National Cost Extracts for inpatient encounters.15 We then contacted each veteran by telephone and asked whether they had experienced NCD and, if so, its weekly frequency ranging from once to nightly.

Data Analysis

Data were reported as mean (SD) where appropriate. The t test and Fisher exact test were used as indicated. P < .05 was considered statistically significant. The study protocol was determined to be exempt by the JBVAMC Institutional Review Board (Protocol #1725748).

 

 

RESULTS

table 1

During the study period, 75 patients with hypoxemic CRF from COPD received LTOT and were followed at the JBVAMC. No patients were hospitalized outside the JBVAMC for COPD exacerbation during this time frame. We also found no documentation in the EHRs indicating that the clinicians managing these patients at the JBVAMC inquired about NCD during sleep.

figure

Of the 75 patients, 66 (88%) responded to the telephone survey and 22 patients (33%) reported weekly episodes of NCD while they slept (median, 4 dislodgments per week). (Table 1). Eight patients (36%) reported nightly NCDs (Figure). All 66 respondents were male and 14 of 22 in the NCD group as well as 21 of 44 in the no NCD group were Black veterans. The mean age was similar in both groups: 71 years in the NCD group and 72 years in the no NCD group. There were no statistically significant differences in demographics, including prevalence of obstructive sleep apnea (OSA), supplemental oxygen flow rate, and duration of LTOT, or in pulmonary function test results between patients who did and did not experience NCD while sleeping (Table 2).

table 3
table 2

Ten of 22 patients (45%) with NCD and 9 of 44 patients (20%) without NCD were hospitalized at the JBVAMC for ≥ 1 COPD exacerbation in the preceding year that was diagnosed by a physician (P = .045). Three of 22 patients (14%) with NCD and no patients in the no NCD group were admitted to the MICU. No patients required intubation and mechanical ventilation during hospitalization, and no patients died. Overall hospital costs were 25% ($64,342) higher in NCD group compared with the no NCD group and were attributed to the MICU admissions in the NCD group (Table 3). Nine veterans did not respond to repeated telephone calls. One physician-diagnosed COPD exacerbation requiring hospitalization was documented in the nonresponder group; the patient was hospitalized for 2 days. One veteran died before being contacted.

 

 

DISCUSSION

There are 3 new findings in this study. First, health care practitioners at JBVAMC did not document the presence of NCD during sleep in patients with hypoxemic CRF due to COPD and receiving LTOT. Second, one-third of these patients reported frequent NCD during sleep when interviewed. Third, the nocturnal events were associated with a higher hospitalization rate for physician-diagnosed COPD exacerbation and higher overall hospital costs. These findings are unlikely to be explained by differences in COPD severity and/or known triggers that lead to COPD exacerbation and require hospitalization because baseline physiologic and LTOT parameters were similar in both groups. Conceivably, patients with untreated OSA could be restless while asleep, leading to NCD. However, this explanation seems unlikely because the frequency of OSA was similar in both groups.

Nocturnal arterial oxygen desaturation in patients with COPD without evidence of OSA may contribute to the frequency of exacerbations.16 Although the mechanism(s) underlying this phenomenon is uncertain, we posit that prolonged nocturnal airway wall hypoxia could amplify underlying chronic inflammation through local generation of reactive oxygen species, thereby predisposing patients to exacerbations. Frequent COPD exacerbations promote disease progression and health status decline and are associated with increased mortality.11,13 Moreover, hospitalization of patients with COPD is the largest contributor to the annual direct cost of COPD per patient.10,12 The higher hospitalization rate observed in the NCD group in our study suggests that interruption of supplemental oxygen delivery while asleep may be a risk factor for COPD exacerbation. Alternatively, an independent factor or factors may have contributed to both NCD during sleep and COPD exacerbation in these patients or an impending exacerbation resulted in sleep disturbances that led to NCD. Additional research is warranted on veterans with hypoxemic CRF from COPD who are receiving LTOT and report frequent NCD during sleep that may support or refute these hypotheses.

To the best of our knowledge, NCD during sleep has not been previously reported in patients with hypoxemic CRF due to COPD who are receiving LTOT at home or in an acute care setting.17-20 Several layperson proposals to secure nasal cannulas to the face while sleeping are posted online. These include wearing a commercially available headband with 2 Velcro loops that fix the cannula tube, using fabric medical tape on both cheeks, and wearing a sleep mask. Conceivably, the efficacy and safety of these inexpensive interventions to mitigate NCD during sleep in patients receiving LTOT with hypoxemic CRF from COPD could be tested in clinical trials.

Limitations

This was a small, single-site study, comprised entirely of male patients who are predominantly Black veterans. The telephone interviews with veterans self-reporting NCD during their sleep are prone to recall bias. In addition, the validity and reproducibility of NCD during sleep were not addressed in this study. Missing data from 9 nonresponders may have introduced a nonresponse bias in data analysis and interpretation. The overall hospital cost for a COPD exacerbation at JBVAMC was derived from VA data; US Centers for Medicare & Medicaid Services or commercial carrier data may be different.15,21 Lastly, access to LTOT for veterans with hypoxemic CRF from COPD is regulated and supervised at VA medical facilities.14 This process may be different for patients outside the VA. Taken together, it is difficult to generalize our initial observations to non-VA patients with hypoxemic CRF from COPD who are receiving LTOT. We suggest a large, prospective study of veterans be conducted to determine the prevalence of NCD during sleep and its relationship with COPD exacerbations in veterans receiving LTOT with hypoxemic CRF due to COPD.

CONCLUSIONS

Clinicians at the JBVAMC did not document the presence of NCD during sleep in patients with hypoxemic CRF from COPD who received LTOT. However, self-reported, weekly nocturnal NCD episodes were associated with a higher hospitalization rate for COPD exacerbation and higher hospital costs. Accordingly, user-friendly devices to mitigate NCD during sleep should be developed.

Acknowledgments

We thank Yolanda Davis, RRT, and George Adam for their assistance with this project.

References

1. Boersma P, Cohen RA, Zelaya CE, Moy E. Multiple chronic conditions among veterans and nonveterans: United States, 2015-2018. Natl Health Stat Report. 2021;(153):1-13. doi:10.15620/cdc:101659

2. Sharafkhaneh A, Petersen NJ, Yu H-J, Dalal AA, Johnson ML, Hanania NA. Burden of COPD in a government health care system: a retrospective observational study using data from the US Veterans Affairs population. Int J Chron Obstruct Pulmon Dis. 2010;5:125-132. doi:10.2147/copd.s8047

3. LaBedz SL, Krishnan JA, Chung Y-C, et al. Chronic obstructive pulmonary disease outcomes at Veterans Affairs versus non-Veterans Affairs hospitals. Chronic Obstr Pulm Dis. 2021;8(3):306-313. doi:10.15326/jcopdf.2021.0201

4. Darnell K, Dwivedi AK, Weng Z, Panos RJ. Disproportionate utilization of healthcare resources among veterans with COPD: a retrospective analysis of factors associated with COPD healthcare cost. Cost Eff Resour Alloc. 2013;11:13. doi:10.1186/1478-7547-11-13

5. Bamonti PM, Robinson SA, Wan ES, Moy ML. Improving physiological, physical, and psychological health outcomes: a narrative review in US Veterans with COPD. Int J Chron Obstruct Pulmon Dis. 2022;17:1269-1283. doi:10.2147/COPD.S339323

6. Cranston JM, Crockett AJ, Moss JR, Alpers JH. Domiciliary oxygen for chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2005;2005(4):CD001744. doi:10.1002/14651858.CD001744.pub2

7. Lacasse Y, Tan AM, Maltais F, Krishnan JA. Home oxygen in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2018;197(10):1254-1264. doi:10.1164/rccm.201802-0382CI

8. Jacobs SS, Krishnan JA, Lederer DJ, et al. Home oxygen therapy for adults with chronic lung disease. An official American Thoracic Society Clinical Practice Guideline. Am J Respir Crit Care Med. 2020;202(10):e121-e141. doi:10.1164/rccm.202009-3608ST

9. AARC. AARC clinical practice guideline. Oxygen therapy in the home or alternate site health care facility--2007 revision & update. Respir Care. 2007;52(8):1063-1068.

10. Foo J, Landis SH, Maskell J, et al. Continuing to confront COPD international patient survey: economic impact of COPD in 12 countries. PLoS One. 2016;11(4):e0152618. doi:10.1371/journal.pone.0152618

11. Rothnie KJ, Müllerová H, Smeeth L, Quint JK. Natural history of chronic obstructive pulmonary disease exacerbations in a general practice-based population with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2018;198(4):464-471. doi:10.1164/rccm.201710-2029OC

12. Stanford RH, Engel-Nitz NM, Bancroft T, Essoi B. The identification and cost of acute chronic obstructive pulmonary disease exacerbations in a United States population healthcare claims database. COPD. 2020;17(5):499-508. doi:10.1080/15412555.2020.1817357

13. Hurst JR, Han MK, Singh B, et al. Prognostic risk factors for moderate-to-severe exacerbations in patients with chronic obstructive pulmonary disease: a systematic literature review. Respir Res. 2022;23(1):213. doi:10.1186/s12931-022-02123-5

14. US Department of Veterans Affairs, Veterans Health Administration. Home oxygen program. VHA Directive 1173.13(1). Published August 5, 2020. Accessed February 28, 2024. https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=8947

15. Phibbs CS, Barnett PG, Fan A, Harden C, King SS, Scott JY. Research guide to decision support system national cost extracts. Health Economics Resource Center of Health Service R&D Services, US Department of Veterans Affairs. September 2010. Accessed February 14, 2024. https://www.herc.research.va.gov/files/book_621.pdf

16. Agusti A, Hedner J, Marin JM, Barbé F, Cazzola M, Rennard S. Night-time symptoms: a forgotten dimension of COPD. Eur Respir Rev. 2011;20(121):183-194. doi:10.1183/09059180.00004311

17. Croxton TL, Bailey WC. Long-term oxygen treatment in chronic obstructive pulmonary disease: recommendations for future research: an NHLBI workshop report. Am J Respir Crit Care Med. 2006;174(4):373-378. doi:10.1164/rccm.200507-1161WS

18. Melani AS, Sestini P, Rottoli P. Home oxygen therapy: re-thinking the role of devices. Expert Rev Clin Pharmacol. 2018;11(3):279-289. doi:10.1080/17512433.2018.1421457

19. Sculley JA, Corbridge SJ, Prieto-Centurion V, et al. Home oxygen therapy for patients with COPD: time for a reboot. Respir Care. 2019;64(12):1574-1585. doi:10.4187/respcare.07135

20. Jacobs SS, Lindell KO, Collins EG, et al. Patient perceptions of the adequacy of supplemental oxygen therapy. Results of the American Thoracic Society Nursing Assembly Oxygen Working Group Survey. Ann Am Thorac Soc. 2018;15:24-32. doi:10.1513/AnnalsATS.201703-209OC

21. US Centers for Medicare & Medicaid Services. Home use of oxygen. Publication number 100-3. January 3, 2023. Accessed February 14, 2024. https://www.cms.gov/medicare-coverage-database/view/ncd.aspx?NCDId=169

References

1. Boersma P, Cohen RA, Zelaya CE, Moy E. Multiple chronic conditions among veterans and nonveterans: United States, 2015-2018. Natl Health Stat Report. 2021;(153):1-13. doi:10.15620/cdc:101659

2. Sharafkhaneh A, Petersen NJ, Yu H-J, Dalal AA, Johnson ML, Hanania NA. Burden of COPD in a government health care system: a retrospective observational study using data from the US Veterans Affairs population. Int J Chron Obstruct Pulmon Dis. 2010;5:125-132. doi:10.2147/copd.s8047

3. LaBedz SL, Krishnan JA, Chung Y-C, et al. Chronic obstructive pulmonary disease outcomes at Veterans Affairs versus non-Veterans Affairs hospitals. Chronic Obstr Pulm Dis. 2021;8(3):306-313. doi:10.15326/jcopdf.2021.0201

4. Darnell K, Dwivedi AK, Weng Z, Panos RJ. Disproportionate utilization of healthcare resources among veterans with COPD: a retrospective analysis of factors associated with COPD healthcare cost. Cost Eff Resour Alloc. 2013;11:13. doi:10.1186/1478-7547-11-13

5. Bamonti PM, Robinson SA, Wan ES, Moy ML. Improving physiological, physical, and psychological health outcomes: a narrative review in US Veterans with COPD. Int J Chron Obstruct Pulmon Dis. 2022;17:1269-1283. doi:10.2147/COPD.S339323

6. Cranston JM, Crockett AJ, Moss JR, Alpers JH. Domiciliary oxygen for chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2005;2005(4):CD001744. doi:10.1002/14651858.CD001744.pub2

7. Lacasse Y, Tan AM, Maltais F, Krishnan JA. Home oxygen in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2018;197(10):1254-1264. doi:10.1164/rccm.201802-0382CI

8. Jacobs SS, Krishnan JA, Lederer DJ, et al. Home oxygen therapy for adults with chronic lung disease. An official American Thoracic Society Clinical Practice Guideline. Am J Respir Crit Care Med. 2020;202(10):e121-e141. doi:10.1164/rccm.202009-3608ST

9. AARC. AARC clinical practice guideline. Oxygen therapy in the home or alternate site health care facility--2007 revision & update. Respir Care. 2007;52(8):1063-1068.

10. Foo J, Landis SH, Maskell J, et al. Continuing to confront COPD international patient survey: economic impact of COPD in 12 countries. PLoS One. 2016;11(4):e0152618. doi:10.1371/journal.pone.0152618

11. Rothnie KJ, Müllerová H, Smeeth L, Quint JK. Natural history of chronic obstructive pulmonary disease exacerbations in a general practice-based population with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2018;198(4):464-471. doi:10.1164/rccm.201710-2029OC

12. Stanford RH, Engel-Nitz NM, Bancroft T, Essoi B. The identification and cost of acute chronic obstructive pulmonary disease exacerbations in a United States population healthcare claims database. COPD. 2020;17(5):499-508. doi:10.1080/15412555.2020.1817357

13. Hurst JR, Han MK, Singh B, et al. Prognostic risk factors for moderate-to-severe exacerbations in patients with chronic obstructive pulmonary disease: a systematic literature review. Respir Res. 2022;23(1):213. doi:10.1186/s12931-022-02123-5

14. US Department of Veterans Affairs, Veterans Health Administration. Home oxygen program. VHA Directive 1173.13(1). Published August 5, 2020. Accessed February 28, 2024. https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=8947

15. Phibbs CS, Barnett PG, Fan A, Harden C, King SS, Scott JY. Research guide to decision support system national cost extracts. Health Economics Resource Center of Health Service R&D Services, US Department of Veterans Affairs. September 2010. Accessed February 14, 2024. https://www.herc.research.va.gov/files/book_621.pdf

16. Agusti A, Hedner J, Marin JM, Barbé F, Cazzola M, Rennard S. Night-time symptoms: a forgotten dimension of COPD. Eur Respir Rev. 2011;20(121):183-194. doi:10.1183/09059180.00004311

17. Croxton TL, Bailey WC. Long-term oxygen treatment in chronic obstructive pulmonary disease: recommendations for future research: an NHLBI workshop report. Am J Respir Crit Care Med. 2006;174(4):373-378. doi:10.1164/rccm.200507-1161WS

18. Melani AS, Sestini P, Rottoli P. Home oxygen therapy: re-thinking the role of devices. Expert Rev Clin Pharmacol. 2018;11(3):279-289. doi:10.1080/17512433.2018.1421457

19. Sculley JA, Corbridge SJ, Prieto-Centurion V, et al. Home oxygen therapy for patients with COPD: time for a reboot. Respir Care. 2019;64(12):1574-1585. doi:10.4187/respcare.07135

20. Jacobs SS, Lindell KO, Collins EG, et al. Patient perceptions of the adequacy of supplemental oxygen therapy. Results of the American Thoracic Society Nursing Assembly Oxygen Working Group Survey. Ann Am Thorac Soc. 2018;15:24-32. doi:10.1513/AnnalsATS.201703-209OC

21. US Centers for Medicare & Medicaid Services. Home use of oxygen. Publication number 100-3. January 3, 2023. Accessed February 14, 2024. https://www.cms.gov/medicare-coverage-database/view/ncd.aspx?NCDId=169

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Regular Exercise Linked to Better Sleep

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Changed
Wed, 04/03/2024 - 07:31

 

TOPLINE:

Over time, exercising at least twice a week is associated with significantly fewer insomnia symptoms and better sleep duration, new research shows.

METHODOLOGY:

  • The study included 4339 adults aged 39-67 years (48% men) from 21 centers in nine countries participating in the third follow-up to the European Community Respiratory Health Survey (ECRHS III).
  • Participants responded to questions about physical activity, insomnia symptoms, sleep duration, and daytime sleepiness at 10-year follow-up.
  • Being “physically active” was defined as exercising with a frequency of at least twice a week for ≥ 1 hour per week.
  • The main outcome measures were insomnia, sleep time, and daytime sleepiness in relation to physical activity.

TAKEAWAY:

  • From baseline to follow-up, 37% of participants were persistently inactive, 25% were persistently active, 20% became inactive, and 18% became active.
  • After adjustment for age, sex, body mass index, smoking history, and study center, persistently active participants were less likely to report difficulties with sleep initiation (adjusted odds ratio [aOR], 0.60; 95% CI, 0.45-0.78), with short sleep duration of ≤ 6 hours/night (aOR, 0.71; 95% CI, 0.59-0.85) and long sleep of ≥ 9 hours/night (aOR, 0.53; 95% CI, 0.33-0.84), compared with persistently nonactive subjects.
  • Those who were persistently active were 22% less likely to report any symptoms of insomnia, 40% less likely to report two symptoms, and 37% less likely to report three symptoms.
  • Daytime sleepiness and difficulties maintaining sleep were found to be unrelated to physical activity status.

IN PRACTICE:

“This study has a long follow-up period (10 years) and indicates strongly that consistency in physical activity might be an important factor in optimizing sleep duration and reducing the symptoms of insomnia,” the authors wrote.

SOURCE:

Erla Björnsdóttir, of the Department of Psychology, Reykjavik University, Reykjavik, Iceland, was the co-senior author and corresponding author of the study. It was published online on March 25 in BMJ Open.

LIMITATIONS:

It’s unclear whether individuals who were active at both timepoints had been continuously physically active throughout the study period or only at those two timepoints. Sleep variables were available only at follow-up and were all subjectively reported, meaning the associations between physical activity and sleep may not be longitudinal. Residual confounders (eg, mental health and musculoskeletal disorders or chronic pain) that can influence both sleep and exercise were not explored.

DISCLOSURES:

Financial support for ECRHS III was provided by the National Health and Medical Research Council (Australia); Antwerp South, Antwerp City: Research Foundation Flanders (Belgium); Estonian Ministry of Education (Estonia); and other international agencies. Additional sources of funding were listed on the original paper. The authors reported no relevant financial relationships.

A version of this article appeared on Medscape.com.

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TOPLINE:

Over time, exercising at least twice a week is associated with significantly fewer insomnia symptoms and better sleep duration, new research shows.

METHODOLOGY:

  • The study included 4339 adults aged 39-67 years (48% men) from 21 centers in nine countries participating in the third follow-up to the European Community Respiratory Health Survey (ECRHS III).
  • Participants responded to questions about physical activity, insomnia symptoms, sleep duration, and daytime sleepiness at 10-year follow-up.
  • Being “physically active” was defined as exercising with a frequency of at least twice a week for ≥ 1 hour per week.
  • The main outcome measures were insomnia, sleep time, and daytime sleepiness in relation to physical activity.

TAKEAWAY:

  • From baseline to follow-up, 37% of participants were persistently inactive, 25% were persistently active, 20% became inactive, and 18% became active.
  • After adjustment for age, sex, body mass index, smoking history, and study center, persistently active participants were less likely to report difficulties with sleep initiation (adjusted odds ratio [aOR], 0.60; 95% CI, 0.45-0.78), with short sleep duration of ≤ 6 hours/night (aOR, 0.71; 95% CI, 0.59-0.85) and long sleep of ≥ 9 hours/night (aOR, 0.53; 95% CI, 0.33-0.84), compared with persistently nonactive subjects.
  • Those who were persistently active were 22% less likely to report any symptoms of insomnia, 40% less likely to report two symptoms, and 37% less likely to report three symptoms.
  • Daytime sleepiness and difficulties maintaining sleep were found to be unrelated to physical activity status.

IN PRACTICE:

“This study has a long follow-up period (10 years) and indicates strongly that consistency in physical activity might be an important factor in optimizing sleep duration and reducing the symptoms of insomnia,” the authors wrote.

SOURCE:

Erla Björnsdóttir, of the Department of Psychology, Reykjavik University, Reykjavik, Iceland, was the co-senior author and corresponding author of the study. It was published online on March 25 in BMJ Open.

LIMITATIONS:

It’s unclear whether individuals who were active at both timepoints had been continuously physically active throughout the study period or only at those two timepoints. Sleep variables were available only at follow-up and were all subjectively reported, meaning the associations between physical activity and sleep may not be longitudinal. Residual confounders (eg, mental health and musculoskeletal disorders or chronic pain) that can influence both sleep and exercise were not explored.

DISCLOSURES:

Financial support for ECRHS III was provided by the National Health and Medical Research Council (Australia); Antwerp South, Antwerp City: Research Foundation Flanders (Belgium); Estonian Ministry of Education (Estonia); and other international agencies. Additional sources of funding were listed on the original paper. The authors reported no relevant financial relationships.

A version of this article appeared on Medscape.com.

 

TOPLINE:

Over time, exercising at least twice a week is associated with significantly fewer insomnia symptoms and better sleep duration, new research shows.

METHODOLOGY:

  • The study included 4339 adults aged 39-67 years (48% men) from 21 centers in nine countries participating in the third follow-up to the European Community Respiratory Health Survey (ECRHS III).
  • Participants responded to questions about physical activity, insomnia symptoms, sleep duration, and daytime sleepiness at 10-year follow-up.
  • Being “physically active” was defined as exercising with a frequency of at least twice a week for ≥ 1 hour per week.
  • The main outcome measures were insomnia, sleep time, and daytime sleepiness in relation to physical activity.

TAKEAWAY:

  • From baseline to follow-up, 37% of participants were persistently inactive, 25% were persistently active, 20% became inactive, and 18% became active.
  • After adjustment for age, sex, body mass index, smoking history, and study center, persistently active participants were less likely to report difficulties with sleep initiation (adjusted odds ratio [aOR], 0.60; 95% CI, 0.45-0.78), with short sleep duration of ≤ 6 hours/night (aOR, 0.71; 95% CI, 0.59-0.85) and long sleep of ≥ 9 hours/night (aOR, 0.53; 95% CI, 0.33-0.84), compared with persistently nonactive subjects.
  • Those who were persistently active were 22% less likely to report any symptoms of insomnia, 40% less likely to report two symptoms, and 37% less likely to report three symptoms.
  • Daytime sleepiness and difficulties maintaining sleep were found to be unrelated to physical activity status.

IN PRACTICE:

“This study has a long follow-up period (10 years) and indicates strongly that consistency in physical activity might be an important factor in optimizing sleep duration and reducing the symptoms of insomnia,” the authors wrote.

SOURCE:

Erla Björnsdóttir, of the Department of Psychology, Reykjavik University, Reykjavik, Iceland, was the co-senior author and corresponding author of the study. It was published online on March 25 in BMJ Open.

LIMITATIONS:

It’s unclear whether individuals who were active at both timepoints had been continuously physically active throughout the study period or only at those two timepoints. Sleep variables were available only at follow-up and were all subjectively reported, meaning the associations between physical activity and sleep may not be longitudinal. Residual confounders (eg, mental health and musculoskeletal disorders or chronic pain) that can influence both sleep and exercise were not explored.

DISCLOSURES:

Financial support for ECRHS III was provided by the National Health and Medical Research Council (Australia); Antwerp South, Antwerp City: Research Foundation Flanders (Belgium); Estonian Ministry of Education (Estonia); and other international agencies. Additional sources of funding were listed on the original paper. The authors reported no relevant financial relationships.

A version of this article appeared on Medscape.com.

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Magnesium Spray for Better Sleep? Experts Weigh In

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Thu, 04/11/2024 - 16:00

As your patient’s scheduled bedtime is approaching, they begin to worry another restless night is looming. Could magnesium oil spray actually help them sleep? Some — even doctors — are sharing testimonials about how this simple tactic transformed their sleep quality. Experts suggest some sleep improvement is possible, though it does not negate the need for treatment, and should not be used in patients with cardiovascular disease.

Take Daniel Barrett, MD, a board-certified plastic surgeon and owner of Barrett Plastic Surgery in Beverly Hills, as an example. He decided to test whether magnesium oil could indeed give him a sleepy sensation and shared his experience. Dr. Barrett sprayed magnesium oil on his feet — until they felt “slippery and wet,” he said — and put his socks back on. (He said magnesium is absorbed more easily through the skin. Putting it on the skin helps this mineral get into the lymphatics and circulatory system, offering a way to get a higher concentration of magnesium in the bloodstream. The pores on the feet are also said to be the largest on the body, making them an ideal place for absorption.) 

“My central nervous system had calmed down a bit — it’s similar to what I feel when I take oral magnesium as well. It took about 15 minutes to feel the effect,” Dr. Barrett said.

Research shows that magnesium blocks N-methyl-D-aspartate (a receptor that can hinder sleep) and stimulates gamma-aminobutyric acid (a receptor that can promote good sleep), said Dennis Auckley, MD, director of MetroHealth’s Center for Sleep Medicine. And studies looking at the effects of oral magnesium have shown that taking it may be linked to better self-reported sleep quality and less daytime sleepiness, he said. But traditional magnesium supplements taken orally can sometimes come with side effects in your gut, so putting magnesium on the skin could help to avoid this. 

Magnesium oil on the feet could also help with certain sleep disturbances, such as nocturnal leg cramps and restless legs syndrome, said Sam Kashani, MD, a sleep medicine specialist and assistant clinical professor at UCLA Medical School. (Nocturnal leg cramps – one of the most common secondary factors of insomnia and sleep disturbances in older adults – includes sudden, painful contractions in the lower leg muscles while sleeping. Restless legs syndrome, on the other hand, is like nocturnal leg cramps, but minus the painful contractions, said Dr. Kashani.) 

Magnesium is a mineral that does have some benefit with regard to reducing the muscle tightness and promoting a little bit more of relaxation of the muscles,” Dr. Kashani said. “This [magnesium oil on your soles] could be beneficial for these types of sleep problems.” 

Still, sleep medicine experts stressed that putting magnesium oil on your feet should not be viewed a cure-all for sleep troubles. 

“High-quality scientific evidence supporting magnesium as a sleep remedy is severely limited,” said Emerson Wickwire, PhD, an American Academy of Sleep Medicine spokesperson and section head of sleep medicine at the University of Maryland Medical School. “Certainly, magnesium is not supported as a treatment for sleep disorders.” 

If your patients plan to use magnesium oil on their feet to help them sleep, make sure they carefully follow the directions to make sure they are taking the proper dosage. Most importantly, patients with a history of cardiovascular complications, or issues with the heart and blood vessels should consult their doctor. 

“Magnesium is an electrolyte that has multiple roles and functions in the body, including within our cardiovascular system,” Dr. Kashani said. “So, if you are somebody who has heart troubles, you definitely want to talk to your primary doctor about any kind of supplements that you are taking, including magnesium.”
 

A version of this article appeared on WebMD.com.

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As your patient’s scheduled bedtime is approaching, they begin to worry another restless night is looming. Could magnesium oil spray actually help them sleep? Some — even doctors — are sharing testimonials about how this simple tactic transformed their sleep quality. Experts suggest some sleep improvement is possible, though it does not negate the need for treatment, and should not be used in patients with cardiovascular disease.

Take Daniel Barrett, MD, a board-certified plastic surgeon and owner of Barrett Plastic Surgery in Beverly Hills, as an example. He decided to test whether magnesium oil could indeed give him a sleepy sensation and shared his experience. Dr. Barrett sprayed magnesium oil on his feet — until they felt “slippery and wet,” he said — and put his socks back on. (He said magnesium is absorbed more easily through the skin. Putting it on the skin helps this mineral get into the lymphatics and circulatory system, offering a way to get a higher concentration of magnesium in the bloodstream. The pores on the feet are also said to be the largest on the body, making them an ideal place for absorption.) 

“My central nervous system had calmed down a bit — it’s similar to what I feel when I take oral magnesium as well. It took about 15 minutes to feel the effect,” Dr. Barrett said.

Research shows that magnesium blocks N-methyl-D-aspartate (a receptor that can hinder sleep) and stimulates gamma-aminobutyric acid (a receptor that can promote good sleep), said Dennis Auckley, MD, director of MetroHealth’s Center for Sleep Medicine. And studies looking at the effects of oral magnesium have shown that taking it may be linked to better self-reported sleep quality and less daytime sleepiness, he said. But traditional magnesium supplements taken orally can sometimes come with side effects in your gut, so putting magnesium on the skin could help to avoid this. 

Magnesium oil on the feet could also help with certain sleep disturbances, such as nocturnal leg cramps and restless legs syndrome, said Sam Kashani, MD, a sleep medicine specialist and assistant clinical professor at UCLA Medical School. (Nocturnal leg cramps – one of the most common secondary factors of insomnia and sleep disturbances in older adults – includes sudden, painful contractions in the lower leg muscles while sleeping. Restless legs syndrome, on the other hand, is like nocturnal leg cramps, but minus the painful contractions, said Dr. Kashani.) 

Magnesium is a mineral that does have some benefit with regard to reducing the muscle tightness and promoting a little bit more of relaxation of the muscles,” Dr. Kashani said. “This [magnesium oil on your soles] could be beneficial for these types of sleep problems.” 

Still, sleep medicine experts stressed that putting magnesium oil on your feet should not be viewed a cure-all for sleep troubles. 

“High-quality scientific evidence supporting magnesium as a sleep remedy is severely limited,” said Emerson Wickwire, PhD, an American Academy of Sleep Medicine spokesperson and section head of sleep medicine at the University of Maryland Medical School. “Certainly, magnesium is not supported as a treatment for sleep disorders.” 

If your patients plan to use magnesium oil on their feet to help them sleep, make sure they carefully follow the directions to make sure they are taking the proper dosage. Most importantly, patients with a history of cardiovascular complications, or issues with the heart and blood vessels should consult their doctor. 

“Magnesium is an electrolyte that has multiple roles and functions in the body, including within our cardiovascular system,” Dr. Kashani said. “So, if you are somebody who has heart troubles, you definitely want to talk to your primary doctor about any kind of supplements that you are taking, including magnesium.”
 

A version of this article appeared on WebMD.com.

As your patient’s scheduled bedtime is approaching, they begin to worry another restless night is looming. Could magnesium oil spray actually help them sleep? Some — even doctors — are sharing testimonials about how this simple tactic transformed their sleep quality. Experts suggest some sleep improvement is possible, though it does not negate the need for treatment, and should not be used in patients with cardiovascular disease.

Take Daniel Barrett, MD, a board-certified plastic surgeon and owner of Barrett Plastic Surgery in Beverly Hills, as an example. He decided to test whether magnesium oil could indeed give him a sleepy sensation and shared his experience. Dr. Barrett sprayed magnesium oil on his feet — until they felt “slippery and wet,” he said — and put his socks back on. (He said magnesium is absorbed more easily through the skin. Putting it on the skin helps this mineral get into the lymphatics and circulatory system, offering a way to get a higher concentration of magnesium in the bloodstream. The pores on the feet are also said to be the largest on the body, making them an ideal place for absorption.) 

“My central nervous system had calmed down a bit — it’s similar to what I feel when I take oral magnesium as well. It took about 15 minutes to feel the effect,” Dr. Barrett said.

Research shows that magnesium blocks N-methyl-D-aspartate (a receptor that can hinder sleep) and stimulates gamma-aminobutyric acid (a receptor that can promote good sleep), said Dennis Auckley, MD, director of MetroHealth’s Center for Sleep Medicine. And studies looking at the effects of oral magnesium have shown that taking it may be linked to better self-reported sleep quality and less daytime sleepiness, he said. But traditional magnesium supplements taken orally can sometimes come with side effects in your gut, so putting magnesium on the skin could help to avoid this. 

Magnesium oil on the feet could also help with certain sleep disturbances, such as nocturnal leg cramps and restless legs syndrome, said Sam Kashani, MD, a sleep medicine specialist and assistant clinical professor at UCLA Medical School. (Nocturnal leg cramps – one of the most common secondary factors of insomnia and sleep disturbances in older adults – includes sudden, painful contractions in the lower leg muscles while sleeping. Restless legs syndrome, on the other hand, is like nocturnal leg cramps, but minus the painful contractions, said Dr. Kashani.) 

Magnesium is a mineral that does have some benefit with regard to reducing the muscle tightness and promoting a little bit more of relaxation of the muscles,” Dr. Kashani said. “This [magnesium oil on your soles] could be beneficial for these types of sleep problems.” 

Still, sleep medicine experts stressed that putting magnesium oil on your feet should not be viewed a cure-all for sleep troubles. 

“High-quality scientific evidence supporting magnesium as a sleep remedy is severely limited,” said Emerson Wickwire, PhD, an American Academy of Sleep Medicine spokesperson and section head of sleep medicine at the University of Maryland Medical School. “Certainly, magnesium is not supported as a treatment for sleep disorders.” 

If your patients plan to use magnesium oil on their feet to help them sleep, make sure they carefully follow the directions to make sure they are taking the proper dosage. Most importantly, patients with a history of cardiovascular complications, or issues with the heart and blood vessels should consult their doctor. 

“Magnesium is an electrolyte that has multiple roles and functions in the body, including within our cardiovascular system,” Dr. Kashani said. “So, if you are somebody who has heart troubles, you definitely want to talk to your primary doctor about any kind of supplements that you are taking, including magnesium.”
 

A version of this article appeared on WebMD.com.

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Could Regular, Daytime Naps Increase Glucose Levels?

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Thu, 03/28/2024 - 13:11

 

TOPLINE:

Long naps of an hour or more, naps in the morning, or regular siestas may increase blood glucose levels in older people with type 2 diabetes (T2D).

METHODOLOGY:

  • Napping is common in China and other cultures and may play a role in cardiometabolic health, but previous studies on the relationship between napping and glycemic control in T2D have reported conflicting results.
  • In a cross-sectional study, the researchers assessed 226 individuals with T2D (median age, 67 years; about half women; mostly retired) from two community healthcare centers in China between May 2023 and July 2023.
  • Using questionnaires, the participants were evaluated for A1c levels, as well as frequency, duration (shorter or longer than 1 hour), timing, and type of napping behavior (restorative for lack of sleep vs appetitive by habit or for enjoyment).
  • Multivariate analysis controlled for age, sex, body mass index, T2D treatment regimen, diabetes duration, cognitive impairment, depression, night sleep duration, and insomnia symptoms.

TAKEAWAY:

  • Among 180 participants who reported napping, 61 (33.9%) took long naps of 60 minutes and more, 162 (90%) reported afternoon napping, and 131 (72.8%) displayed appetitive napping.
  • Restorative napping was linked to lower A1c levels than appetitive napping (β, −0.176; P = 0.028).
  • Napping frequency was not associated with A1c levels.

IN PRACTICE:

“In clinical practice, healthcare professionals may offer tips about napping, eg, taking a nap less than an hour, taking a nap in the afternoon instead of in the morning, avoiding appetitive napping,” the authors concluded.

SOURCE:

The study, from corresponding author Bingqian Zhu, PhD, of the Shanghai Jiao Tong University School of Nursing, Shanghai, was published in Frontiers in Endocrinology.

LIMITATIONS:

The participants were older individuals, mostly retired, who may have had less need for restorative napping and more time for appetitive napping, limiting generalizability. The sample size may have been too small to find a link to napping frequency. Self-reported data could introduce recall bias. Only A1c levels were used as a measure of glycemic control.

DISCLOSURES:

The study was supported by the National Natural Science Foundation of China and other sources. The authors declared no potential conflict of interest.

A version of this article appeared on Medscape.com.

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TOPLINE:

Long naps of an hour or more, naps in the morning, or regular siestas may increase blood glucose levels in older people with type 2 diabetes (T2D).

METHODOLOGY:

  • Napping is common in China and other cultures and may play a role in cardiometabolic health, but previous studies on the relationship between napping and glycemic control in T2D have reported conflicting results.
  • In a cross-sectional study, the researchers assessed 226 individuals with T2D (median age, 67 years; about half women; mostly retired) from two community healthcare centers in China between May 2023 and July 2023.
  • Using questionnaires, the participants were evaluated for A1c levels, as well as frequency, duration (shorter or longer than 1 hour), timing, and type of napping behavior (restorative for lack of sleep vs appetitive by habit or for enjoyment).
  • Multivariate analysis controlled for age, sex, body mass index, T2D treatment regimen, diabetes duration, cognitive impairment, depression, night sleep duration, and insomnia symptoms.

TAKEAWAY:

  • Among 180 participants who reported napping, 61 (33.9%) took long naps of 60 minutes and more, 162 (90%) reported afternoon napping, and 131 (72.8%) displayed appetitive napping.
  • Restorative napping was linked to lower A1c levels than appetitive napping (β, −0.176; P = 0.028).
  • Napping frequency was not associated with A1c levels.

IN PRACTICE:

“In clinical practice, healthcare professionals may offer tips about napping, eg, taking a nap less than an hour, taking a nap in the afternoon instead of in the morning, avoiding appetitive napping,” the authors concluded.

SOURCE:

The study, from corresponding author Bingqian Zhu, PhD, of the Shanghai Jiao Tong University School of Nursing, Shanghai, was published in Frontiers in Endocrinology.

LIMITATIONS:

The participants were older individuals, mostly retired, who may have had less need for restorative napping and more time for appetitive napping, limiting generalizability. The sample size may have been too small to find a link to napping frequency. Self-reported data could introduce recall bias. Only A1c levels were used as a measure of glycemic control.

DISCLOSURES:

The study was supported by the National Natural Science Foundation of China and other sources. The authors declared no potential conflict of interest.

A version of this article appeared on Medscape.com.

 

TOPLINE:

Long naps of an hour or more, naps in the morning, or regular siestas may increase blood glucose levels in older people with type 2 diabetes (T2D).

METHODOLOGY:

  • Napping is common in China and other cultures and may play a role in cardiometabolic health, but previous studies on the relationship between napping and glycemic control in T2D have reported conflicting results.
  • In a cross-sectional study, the researchers assessed 226 individuals with T2D (median age, 67 years; about half women; mostly retired) from two community healthcare centers in China between May 2023 and July 2023.
  • Using questionnaires, the participants were evaluated for A1c levels, as well as frequency, duration (shorter or longer than 1 hour), timing, and type of napping behavior (restorative for lack of sleep vs appetitive by habit or for enjoyment).
  • Multivariate analysis controlled for age, sex, body mass index, T2D treatment regimen, diabetes duration, cognitive impairment, depression, night sleep duration, and insomnia symptoms.

TAKEAWAY:

  • Among 180 participants who reported napping, 61 (33.9%) took long naps of 60 minutes and more, 162 (90%) reported afternoon napping, and 131 (72.8%) displayed appetitive napping.
  • Restorative napping was linked to lower A1c levels than appetitive napping (β, −0.176; P = 0.028).
  • Napping frequency was not associated with A1c levels.

IN PRACTICE:

“In clinical practice, healthcare professionals may offer tips about napping, eg, taking a nap less than an hour, taking a nap in the afternoon instead of in the morning, avoiding appetitive napping,” the authors concluded.

SOURCE:

The study, from corresponding author Bingqian Zhu, PhD, of the Shanghai Jiao Tong University School of Nursing, Shanghai, was published in Frontiers in Endocrinology.

LIMITATIONS:

The participants were older individuals, mostly retired, who may have had less need for restorative napping and more time for appetitive napping, limiting generalizability. The sample size may have been too small to find a link to napping frequency. Self-reported data could introduce recall bias. Only A1c levels were used as a measure of glycemic control.

DISCLOSURES:

The study was supported by the National Natural Science Foundation of China and other sources. The authors declared no potential conflict of interest.

A version of this article appeared on Medscape.com.

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Sleep Apnea Is Hard on the Brain

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Mon, 03/25/2024 - 16:54

Symptoms of sleep apnea, including snorting, gasping, or paused breathing during sleep, are associated with a significantly greater risk for problems with cognitive and memory problems, results from a large study showed.

Data from a representative sample of US adults show that those who reported sleep apnea symptoms were about 50% more likely to also report cognitive issues versus their counterparts without such symptoms.

“For clinicians, these findings suggest a potential benefit of considering sleep apnea as a possible contributing or exacerbating factor in individuals experiencing memory or cognitive problems. This could prompt further evaluation for sleep apnea, particularly in at-risk individuals,” said study investigator Dominique Low, MD, MPH, Department of Neurology, Boston Medical Center.

The findings were released ahead of the study’s scheduled presentation at the annual meeting of the American Academy of Neurology.
 

Need to Raise Awareness

The findings are based on 4257 adults who participated in the 2017-2018 National Health and Nutrition Examination Survey and completed questionnaires covering sleep, memory, cognition, and decision-making abilities.

Those who reported snorting, gasping, or breathing pauses during sleep were categorized as experiencing sleep apnea symptoms. Those who reported memory trouble, periods of confusion, difficulty concentrating, or decision-making problems were classified as having memory or cognitive symptoms.

Overall, 1079 participants reported symptoms of sleep apnea. Compared with people without sleep apnea, those with symptoms were more likely to have cognitive problems (33% vs 20%) and have greater odds of having memory or cognitive symptoms, even after adjusting for age, gender, race, and education (adjusted odds ratio, 2.02; P < .001).

“While the study did not establish a cause-and-effect relationship, the findings suggest the importance of raising awareness about the potential link between sleep and cognitive function. Early identification and treatment may improve overall health and potentially lead to a better quality of life,” Dr. Low said.

Limitations of the study include self-reported data on sleep apnea symptoms and cognitive issues sourced from one survey.
 

Consistent Data

Reached for comment, Matthew Pase, PhD, with the Turner Institute for Brain and Mental Health, Monash University, Melbourne, Australia, said the results are similar to earlier work that found a link between obstructive sleep apnea and cognition.

For example, in a recent study, the presence of mild to severe OSA, identified using overnight polysomnography in five community-based cohorts with more than 5900 adults, was associated with poorer cognitive test performance, Dr. Pase said.

“These and other results underscore the importance of healthy sleep for optimal brain health. Future research is needed to test if treating OSA and other sleep disorders can reduce the risk of cognitive impairment,” Dr. Pase said.

Yet, in its latest statement on the topic, the US Preventive Services Task Force concluded there remains insufficient evidence to weigh the balance of benefits and harms of screening for OSA among asymptomatic adults and those with unrecognized symptoms.

The study had no specific funding. Dr. Low and Dr. Pase had no relevant disclosures.
 

A version of this article appeared on Medscape.com.

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Symptoms of sleep apnea, including snorting, gasping, or paused breathing during sleep, are associated with a significantly greater risk for problems with cognitive and memory problems, results from a large study showed.

Data from a representative sample of US adults show that those who reported sleep apnea symptoms were about 50% more likely to also report cognitive issues versus their counterparts without such symptoms.

“For clinicians, these findings suggest a potential benefit of considering sleep apnea as a possible contributing or exacerbating factor in individuals experiencing memory or cognitive problems. This could prompt further evaluation for sleep apnea, particularly in at-risk individuals,” said study investigator Dominique Low, MD, MPH, Department of Neurology, Boston Medical Center.

The findings were released ahead of the study’s scheduled presentation at the annual meeting of the American Academy of Neurology.
 

Need to Raise Awareness

The findings are based on 4257 adults who participated in the 2017-2018 National Health and Nutrition Examination Survey and completed questionnaires covering sleep, memory, cognition, and decision-making abilities.

Those who reported snorting, gasping, or breathing pauses during sleep were categorized as experiencing sleep apnea symptoms. Those who reported memory trouble, periods of confusion, difficulty concentrating, or decision-making problems were classified as having memory or cognitive symptoms.

Overall, 1079 participants reported symptoms of sleep apnea. Compared with people without sleep apnea, those with symptoms were more likely to have cognitive problems (33% vs 20%) and have greater odds of having memory or cognitive symptoms, even after adjusting for age, gender, race, and education (adjusted odds ratio, 2.02; P < .001).

“While the study did not establish a cause-and-effect relationship, the findings suggest the importance of raising awareness about the potential link between sleep and cognitive function. Early identification and treatment may improve overall health and potentially lead to a better quality of life,” Dr. Low said.

Limitations of the study include self-reported data on sleep apnea symptoms and cognitive issues sourced from one survey.
 

Consistent Data

Reached for comment, Matthew Pase, PhD, with the Turner Institute for Brain and Mental Health, Monash University, Melbourne, Australia, said the results are similar to earlier work that found a link between obstructive sleep apnea and cognition.

For example, in a recent study, the presence of mild to severe OSA, identified using overnight polysomnography in five community-based cohorts with more than 5900 adults, was associated with poorer cognitive test performance, Dr. Pase said.

“These and other results underscore the importance of healthy sleep for optimal brain health. Future research is needed to test if treating OSA and other sleep disorders can reduce the risk of cognitive impairment,” Dr. Pase said.

Yet, in its latest statement on the topic, the US Preventive Services Task Force concluded there remains insufficient evidence to weigh the balance of benefits and harms of screening for OSA among asymptomatic adults and those with unrecognized symptoms.

The study had no specific funding. Dr. Low and Dr. Pase had no relevant disclosures.
 

A version of this article appeared on Medscape.com.

Symptoms of sleep apnea, including snorting, gasping, or paused breathing during sleep, are associated with a significantly greater risk for problems with cognitive and memory problems, results from a large study showed.

Data from a representative sample of US adults show that those who reported sleep apnea symptoms were about 50% more likely to also report cognitive issues versus their counterparts without such symptoms.

“For clinicians, these findings suggest a potential benefit of considering sleep apnea as a possible contributing or exacerbating factor in individuals experiencing memory or cognitive problems. This could prompt further evaluation for sleep apnea, particularly in at-risk individuals,” said study investigator Dominique Low, MD, MPH, Department of Neurology, Boston Medical Center.

The findings were released ahead of the study’s scheduled presentation at the annual meeting of the American Academy of Neurology.
 

Need to Raise Awareness

The findings are based on 4257 adults who participated in the 2017-2018 National Health and Nutrition Examination Survey and completed questionnaires covering sleep, memory, cognition, and decision-making abilities.

Those who reported snorting, gasping, or breathing pauses during sleep were categorized as experiencing sleep apnea symptoms. Those who reported memory trouble, periods of confusion, difficulty concentrating, or decision-making problems were classified as having memory or cognitive symptoms.

Overall, 1079 participants reported symptoms of sleep apnea. Compared with people without sleep apnea, those with symptoms were more likely to have cognitive problems (33% vs 20%) and have greater odds of having memory or cognitive symptoms, even after adjusting for age, gender, race, and education (adjusted odds ratio, 2.02; P < .001).

“While the study did not establish a cause-and-effect relationship, the findings suggest the importance of raising awareness about the potential link between sleep and cognitive function. Early identification and treatment may improve overall health and potentially lead to a better quality of life,” Dr. Low said.

Limitations of the study include self-reported data on sleep apnea symptoms and cognitive issues sourced from one survey.
 

Consistent Data

Reached for comment, Matthew Pase, PhD, with the Turner Institute for Brain and Mental Health, Monash University, Melbourne, Australia, said the results are similar to earlier work that found a link between obstructive sleep apnea and cognition.

For example, in a recent study, the presence of mild to severe OSA, identified using overnight polysomnography in five community-based cohorts with more than 5900 adults, was associated with poorer cognitive test performance, Dr. Pase said.

“These and other results underscore the importance of healthy sleep for optimal brain health. Future research is needed to test if treating OSA and other sleep disorders can reduce the risk of cognitive impairment,” Dr. Pase said.

Yet, in its latest statement on the topic, the US Preventive Services Task Force concluded there remains insufficient evidence to weigh the balance of benefits and harms of screening for OSA among asymptomatic adults and those with unrecognized symptoms.

The study had no specific funding. Dr. Low and Dr. Pase had no relevant disclosures.
 

A version of this article appeared on Medscape.com.

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Is Melatonin a Valuable Resource or Children’s Health Risk?

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Changed
Fri, 03/22/2024 - 15:46

For Courtney Stinson, ensuring her daughter’s comfort is a constant battle against the challenges of congenital myopathy. At 9 years old, she relies on a ventilator to breathe, has multiple respiratory treatments daily, and is under the constant care of rotating skilled caregivers. Last year alone, she endured 36 doctor appointments.

To ease her daughter’s struggles with sleep, and after consulting a pediatrician, Ms. Stinson turned to melatonin, a hormone naturally produced by the body to manage sleep. She gave her daughter a low dose of melatonin and saw significant improvement in her ability to settle down, especially when her mind raced.

“She would have such a hard time sleeping when everything is swirling in her head,” said Ms. Stinson, a mother of two who lives in Milan, Michigan. “It’s really been helpful when her brain is moving 100 miles an hour.”

Melatonin is sold without a prescription as a sleep aid in the form of a supplement. For some parents, especially those whose children have complex needs, melatonin can be a valuable resource — but the rise in melatonin across otherwise healthy populations has had its consequences, too, according to pediatric sleep experts. 

Recent data from the CDC illustrates one of these drawbacks: a significant surge in accidental melatonin ingestion among young children over the past 2 decades.

Between 2012 and 2021, poison center calls related to pediatric melatonin exposures skyrocketed by 530%, while emergency department visits for unsupervised melatonin ingestion by infants and young children surged by 420% from 2009 to 2020, according to the CDC report.

Between 2019 and 2022, an estimated 10,930 emergency room visits were linked to 295 cases of children under the age of 6 ingesting melatonin. These incidents accounted for 7.1% of all emergency department visits for medication exposures in this age group, according to the report.

The share of U.S. adults using melatonin increased from 0.4% during 1999 to 2000 to 2.1% during 2017 to 2018.

Doctors say the escalating number of melatonin-related incidents underscores the need for increased awareness and safety measures to protect young children from unintentional overdose, which can cause nausea, vomiting, diarrhea, dizziness, and confusion.

“I do think there is a safe way to use it in certain children, but it should only be used under the guidance of a physician,” said Laura Sterni, MD, director of the Johns Hopkins Pediatric Sleep Center. “There are dangers to using it without that guidance.”
 

Almost 1 in 5 Children Use Melatonin 

Nearly 1 in 5 school-age children and preteens take melatonin for sleep, according to research published last year in JAMA Pediatrics, which also found that 18% of children between 5 and 9 take the supplement.

The American Academy of Sleep Medicine issued a warning in 2022 advising parents to approach the sleep aid with caution. 

“While melatonin can be useful in treating certain sleep-wake disorders, like jet lag, there is much less evidence it can help healthy children or adults fall asleep faster,” M. Adeel Rishi, MD, vice chair of the Academy of Sleep Medicine’s Public Safety Committee, warned on the academy’s site. “Instead of turning to melatonin, parents should work on encouraging their children to develop good sleep habits, like setting a regular bedtime and wake time, having a bedtime routine, and limiting screen time as bedtime approaches.”
 

 

 

What’s the Best Way to Give Kids Melatonin?

Melatonin has been found to work well for children with attention deficit hyperactive disorder (ADHD), autism spectrum disorder, or other conditions like blindness that can hinder the development of a normal circadian rhythm. 

But beyond consulting a pediatrician, caregivers whose children are otherwise healthy should consider trying other approaches to sleep disruption first, Dr. Sterni said, and things like proper sleep hygiene and anxiety should be addressed first. 

“Most sleep problems in children really should be managed with behavioral therapy alone,” she said. “To first pull out a medication to treat that I think is the wrong approach.”

Sterni also recommends starting with the lowest dose possible, which is 0.5 milligrams, with the help of pediatrician. It should be taken 1 to 2 hours before bedtime and 2 hours after their last meal, she said. 

But she notes that because melatonin is sold as a supplement and is not regulated by the FDA, it is impossible to know the exact amount in each dose.

According to JAMA, out of 25 supplements of melatonin, most of the products contained up to 50% more melatonin than what was listed.
 

Dangers of Keeping It Within Reach 

One of the biggest dangers for children is that melatonin is often sold in the form of gummies or chewable tablets — things that appeal to children, said Jenna Wheeler, MD, a pediatric critical care doctor at Orlando Health Arnold Palmer Hospital for Children. 

Because it is sold as a supplement, there are no child-safe packaging requirements. 

“From a critical care standpoint, just remember to keep it up high, not on the nightstand or in a drawer,” Dr. Wheeler said. “A child may eat the whole bottle, thinking, ‘This is just like fruits snacks.’ ”

She noted that the amount people need is often lower than what they buy at the store, and that regardless of whether it is used in proper amounts, it is not meant to be a long-term supplement — for adults or for children.

“Like with anything that’s out there, it’s all about how it’s used,” Dr. Wheeler said. “The problem is when kids get into it accidentally or when it’s not used appropriately.”
 

A version of this article appeared on WebMD.com.

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For Courtney Stinson, ensuring her daughter’s comfort is a constant battle against the challenges of congenital myopathy. At 9 years old, she relies on a ventilator to breathe, has multiple respiratory treatments daily, and is under the constant care of rotating skilled caregivers. Last year alone, she endured 36 doctor appointments.

To ease her daughter’s struggles with sleep, and after consulting a pediatrician, Ms. Stinson turned to melatonin, a hormone naturally produced by the body to manage sleep. She gave her daughter a low dose of melatonin and saw significant improvement in her ability to settle down, especially when her mind raced.

“She would have such a hard time sleeping when everything is swirling in her head,” said Ms. Stinson, a mother of two who lives in Milan, Michigan. “It’s really been helpful when her brain is moving 100 miles an hour.”

Melatonin is sold without a prescription as a sleep aid in the form of a supplement. For some parents, especially those whose children have complex needs, melatonin can be a valuable resource — but the rise in melatonin across otherwise healthy populations has had its consequences, too, according to pediatric sleep experts. 

Recent data from the CDC illustrates one of these drawbacks: a significant surge in accidental melatonin ingestion among young children over the past 2 decades.

Between 2012 and 2021, poison center calls related to pediatric melatonin exposures skyrocketed by 530%, while emergency department visits for unsupervised melatonin ingestion by infants and young children surged by 420% from 2009 to 2020, according to the CDC report.

Between 2019 and 2022, an estimated 10,930 emergency room visits were linked to 295 cases of children under the age of 6 ingesting melatonin. These incidents accounted for 7.1% of all emergency department visits for medication exposures in this age group, according to the report.

The share of U.S. adults using melatonin increased from 0.4% during 1999 to 2000 to 2.1% during 2017 to 2018.

Doctors say the escalating number of melatonin-related incidents underscores the need for increased awareness and safety measures to protect young children from unintentional overdose, which can cause nausea, vomiting, diarrhea, dizziness, and confusion.

“I do think there is a safe way to use it in certain children, but it should only be used under the guidance of a physician,” said Laura Sterni, MD, director of the Johns Hopkins Pediatric Sleep Center. “There are dangers to using it without that guidance.”
 

Almost 1 in 5 Children Use Melatonin 

Nearly 1 in 5 school-age children and preteens take melatonin for sleep, according to research published last year in JAMA Pediatrics, which also found that 18% of children between 5 and 9 take the supplement.

The American Academy of Sleep Medicine issued a warning in 2022 advising parents to approach the sleep aid with caution. 

“While melatonin can be useful in treating certain sleep-wake disorders, like jet lag, there is much less evidence it can help healthy children or adults fall asleep faster,” M. Adeel Rishi, MD, vice chair of the Academy of Sleep Medicine’s Public Safety Committee, warned on the academy’s site. “Instead of turning to melatonin, parents should work on encouraging their children to develop good sleep habits, like setting a regular bedtime and wake time, having a bedtime routine, and limiting screen time as bedtime approaches.”
 

 

 

What’s the Best Way to Give Kids Melatonin?

Melatonin has been found to work well for children with attention deficit hyperactive disorder (ADHD), autism spectrum disorder, or other conditions like blindness that can hinder the development of a normal circadian rhythm. 

But beyond consulting a pediatrician, caregivers whose children are otherwise healthy should consider trying other approaches to sleep disruption first, Dr. Sterni said, and things like proper sleep hygiene and anxiety should be addressed first. 

“Most sleep problems in children really should be managed with behavioral therapy alone,” she said. “To first pull out a medication to treat that I think is the wrong approach.”

Sterni also recommends starting with the lowest dose possible, which is 0.5 milligrams, with the help of pediatrician. It should be taken 1 to 2 hours before bedtime and 2 hours after their last meal, she said. 

But she notes that because melatonin is sold as a supplement and is not regulated by the FDA, it is impossible to know the exact amount in each dose.

According to JAMA, out of 25 supplements of melatonin, most of the products contained up to 50% more melatonin than what was listed.
 

Dangers of Keeping It Within Reach 

One of the biggest dangers for children is that melatonin is often sold in the form of gummies or chewable tablets — things that appeal to children, said Jenna Wheeler, MD, a pediatric critical care doctor at Orlando Health Arnold Palmer Hospital for Children. 

Because it is sold as a supplement, there are no child-safe packaging requirements. 

“From a critical care standpoint, just remember to keep it up high, not on the nightstand or in a drawer,” Dr. Wheeler said. “A child may eat the whole bottle, thinking, ‘This is just like fruits snacks.’ ”

She noted that the amount people need is often lower than what they buy at the store, and that regardless of whether it is used in proper amounts, it is not meant to be a long-term supplement — for adults or for children.

“Like with anything that’s out there, it’s all about how it’s used,” Dr. Wheeler said. “The problem is when kids get into it accidentally or when it’s not used appropriately.”
 

A version of this article appeared on WebMD.com.

For Courtney Stinson, ensuring her daughter’s comfort is a constant battle against the challenges of congenital myopathy. At 9 years old, she relies on a ventilator to breathe, has multiple respiratory treatments daily, and is under the constant care of rotating skilled caregivers. Last year alone, she endured 36 doctor appointments.

To ease her daughter’s struggles with sleep, and after consulting a pediatrician, Ms. Stinson turned to melatonin, a hormone naturally produced by the body to manage sleep. She gave her daughter a low dose of melatonin and saw significant improvement in her ability to settle down, especially when her mind raced.

“She would have such a hard time sleeping when everything is swirling in her head,” said Ms. Stinson, a mother of two who lives in Milan, Michigan. “It’s really been helpful when her brain is moving 100 miles an hour.”

Melatonin is sold without a prescription as a sleep aid in the form of a supplement. For some parents, especially those whose children have complex needs, melatonin can be a valuable resource — but the rise in melatonin across otherwise healthy populations has had its consequences, too, according to pediatric sleep experts. 

Recent data from the CDC illustrates one of these drawbacks: a significant surge in accidental melatonin ingestion among young children over the past 2 decades.

Between 2012 and 2021, poison center calls related to pediatric melatonin exposures skyrocketed by 530%, while emergency department visits for unsupervised melatonin ingestion by infants and young children surged by 420% from 2009 to 2020, according to the CDC report.

Between 2019 and 2022, an estimated 10,930 emergency room visits were linked to 295 cases of children under the age of 6 ingesting melatonin. These incidents accounted for 7.1% of all emergency department visits for medication exposures in this age group, according to the report.

The share of U.S. adults using melatonin increased from 0.4% during 1999 to 2000 to 2.1% during 2017 to 2018.

Doctors say the escalating number of melatonin-related incidents underscores the need for increased awareness and safety measures to protect young children from unintentional overdose, which can cause nausea, vomiting, diarrhea, dizziness, and confusion.

“I do think there is a safe way to use it in certain children, but it should only be used under the guidance of a physician,” said Laura Sterni, MD, director of the Johns Hopkins Pediatric Sleep Center. “There are dangers to using it without that guidance.”
 

Almost 1 in 5 Children Use Melatonin 

Nearly 1 in 5 school-age children and preteens take melatonin for sleep, according to research published last year in JAMA Pediatrics, which also found that 18% of children between 5 and 9 take the supplement.

The American Academy of Sleep Medicine issued a warning in 2022 advising parents to approach the sleep aid with caution. 

“While melatonin can be useful in treating certain sleep-wake disorders, like jet lag, there is much less evidence it can help healthy children or adults fall asleep faster,” M. Adeel Rishi, MD, vice chair of the Academy of Sleep Medicine’s Public Safety Committee, warned on the academy’s site. “Instead of turning to melatonin, parents should work on encouraging their children to develop good sleep habits, like setting a regular bedtime and wake time, having a bedtime routine, and limiting screen time as bedtime approaches.”
 

 

 

What’s the Best Way to Give Kids Melatonin?

Melatonin has been found to work well for children with attention deficit hyperactive disorder (ADHD), autism spectrum disorder, or other conditions like blindness that can hinder the development of a normal circadian rhythm. 

But beyond consulting a pediatrician, caregivers whose children are otherwise healthy should consider trying other approaches to sleep disruption first, Dr. Sterni said, and things like proper sleep hygiene and anxiety should be addressed first. 

“Most sleep problems in children really should be managed with behavioral therapy alone,” she said. “To first pull out a medication to treat that I think is the wrong approach.”

Sterni also recommends starting with the lowest dose possible, which is 0.5 milligrams, with the help of pediatrician. It should be taken 1 to 2 hours before bedtime and 2 hours after their last meal, she said. 

But she notes that because melatonin is sold as a supplement and is not regulated by the FDA, it is impossible to know the exact amount in each dose.

According to JAMA, out of 25 supplements of melatonin, most of the products contained up to 50% more melatonin than what was listed.
 

Dangers of Keeping It Within Reach 

One of the biggest dangers for children is that melatonin is often sold in the form of gummies or chewable tablets — things that appeal to children, said Jenna Wheeler, MD, a pediatric critical care doctor at Orlando Health Arnold Palmer Hospital for Children. 

Because it is sold as a supplement, there are no child-safe packaging requirements. 

“From a critical care standpoint, just remember to keep it up high, not on the nightstand or in a drawer,” Dr. Wheeler said. “A child may eat the whole bottle, thinking, ‘This is just like fruits snacks.’ ”

She noted that the amount people need is often lower than what they buy at the store, and that regardless of whether it is used in proper amounts, it is not meant to be a long-term supplement — for adults or for children.

“Like with anything that’s out there, it’s all about how it’s used,” Dr. Wheeler said. “The problem is when kids get into it accidentally or when it’s not used appropriately.”
 

A version of this article appeared on WebMD.com.

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