Eszopiclone for Sleep Apnea
(CALM-OSA Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether the sleep medication eszopiclone can help individuals with obstructive sleep apnea (OSA) adhere to their CPAP therapy and enhance cognitive function. Researchers believe eszopiclone might facilitate staying asleep with a CPAP machine, potentially improving mental sharpness. Participants will receive either eszopiclone or a placebo, both in conjunction with CPAP therapy. The trial seeks individuals recently diagnosed with OSA, experiencing 10 or more breathing interruptions per hour during sleep. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants an opportunity to contribute to potentially groundbreaking treatment advancements.
Is there any evidence suggesting that eszopiclone is likely to be safe for humans?
Research has shown that eszopiclone is generally safe for use. One study demonstrated that eszopiclone improved sleep quality without worsening sleep apnea, meaning it did not increase the frequency of breathing interruptions during sleep. Another study found that eszopiclone helped individuals stay asleep longer without frequent awakenings.
The FDA has already approved eszopiclone for treating insomnia, indicating a history of safe use. However, like any medication, it can cause side effects. Some individuals might experience dizziness or a metallic taste in their mouth, but these effects are usually mild.
Overall, evidence suggests that eszopiclone is well-tolerated and safe for treating sleep problems, including those related to sleep apnea.12345Why do researchers think this study treatment might be promising?
Unlike the standard treatments for sleep apnea, which typically involve the use of devices like CPAP machines to maintain open airways during sleep, eszopiclone introduces a unique pharmacological approach. Eszopiclone is a hypnotic agent that could potentially enhance sleep quality and continuity by acting on the brain’s GABA receptors, which are linked to promoting sleep. Researchers are excited about eszopiclone because it offers a different mechanism that might improve sleep without solely relying on mechanical interventions, possibly addressing some limitations of current therapies.
What evidence suggests that eszopiclone might be an effective treatment for sleep apnea?
Research has shown that eszopiclone, which participants in this trial may receive, can help people with obstructive sleep apnea (OSA) sleep better. Studies indicate that taking eszopiclone before bed can increase total sleep time by over an hour and help individuals stay asleep longer. It also makes it easier to remain asleep despite breathing issues. Importantly, eszopiclone does not worsen the apnea-hypopnea index (AHI), which measures breathing interruptions. This suggests it could be a safe option for improving sleep in OSA without exacerbating breathing problems.36789
Who Is on the Research Team?
Audrey Zinchuk,, MD, MHS
Principal Investigator
Yale University
Are You a Good Fit for This Trial?
This trial is for individuals with obstructive sleep apnea (OSA) who have an Apnea-Hypopnea Index (AHI) of 10 or higher per hour. Participants should be able to use CPAP therapy and are being evaluated for their adherence and cognitive function while on this treatment.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive CPAP therapy with either eszopiclone or placebo, monitored through split-night polysomnography
Follow-up
Participants are monitored for safety and effectiveness after treatment, including cognitive and cardiovascular assessments
What Are the Treatments Tested in This Trial?
Interventions
- Eszopiclone
Trial Overview
The study is testing whether a drug called eszopiclone can help people with OSA stick to using CPAP better and improve their brain functions, compared to a placebo. It's random, meaning people get put into the drug or placebo group by chance.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Participants will receive eszopiclone the night of the laboratory split-night polysomnography (PSG, sleep monitoring with and without CPAP therapy). Following polysomnography, participants continue with eszopiclone and CPAP therapy
Participants will receive placebo the night of the laboratory split-night polysomnography (PSG, sleep monitoring with and without CPAP therapy). Following polysomnography, participants continue with placebo and CPAP therapy
Find a Clinic Near You
Who Is Running the Clinical Trial?
Yale University
Lead Sponsor
ResMed Foundation
Collaborator
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Citations
Eszopiclone increases the respiratory arousal threshold and ...
Compared with the placebo visit, 3 mg of eszopiclone prior to the 8-h PSG significantly increased total sleep time by over 1 h (Table 1).
The Effect of Eszopiclone on the Arousal Threshold in ...
The purpose of this study is to find out whether taking eszopiclone (Lunesta) changes the breathing effort required to briefly wake people with obstructive ...
A pilot study evaluating acute use of eszopiclone in ...
Conclusions. In this pilot study, eszopiclone did not worsen AHI, and it improved sleep maintenance and efficiency. Further study is warranted to determine ...
The Arousal Threshold as a Drug Target to Improve ...
Eszopiclone increases the respiratory arousal threshold and lowers the apnoea/hypopnoea index in obstructive sleep apnoea patients with a low arousal threshold.
Eszopiclone Improves Overnight Polysomnography and ...
Our data showed that eszopiclone significantly shortened sleep latency, improved sleep efficiency, expanded total sleep time, and enhanced sleep continuity ( ...
An evaluation of the efficacy and safety of eszopiclone over ...
A double-blind placebo-controlled study of eszopiclone found significant, sustained improvement in sleep and daytime function.
Safety and Efficacy of Eszopiclone With Mild to Moderate ...
Frequency and duration of apnea and hypopnea episodes, oxygen saturation, objective sleep parameters and safety information will be collected in this study.
Eszopiclone (Lunesta): a new nonbenzodiazepine hypnotic ...
Secondary analyses indicated that the eszopiclone 2 mg group had significantly less waking after sleep onset; significantly fewer and shorter daytime naps; and ...
Eszopiclone and Zolpidem Do Not Affect the Prevalence of the ...
Data from one small trial showed that treatment with the non benzodiazepine sedative hypnotic (NBSH) eszopiclone improved the apnea-hypopnea index (AHI) in all ...
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