Using a sleep medication to help people with obstructive sleep apnea tolerate CPAP
Continuous Positive Airway Pressure, Arousability and Links to Mechanisms in Obstructive Sleep Apnea
The trial will test whether giving the sleep medicine eszopiclone to people with obstructive sleep apnea (AHI ≥10/hour) helps them stick with CPAP and improves thinking skills.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Yale University Academic / other |
| Locations | 1 site (North Haven, Connecticut) |
| Trial ID | NCT07332442 on ClinicalTrials.gov |
What this trial studies
This randomized, placebo-controlled Phase 3 trial gives adults with newly diagnosed obstructive sleep apnea either eszopiclone or placebo while they begin CPAP therapy to determine if raising the arousal threshold improves outcomes. Primary outcomes are CPAP adherence and change in executive function measured by the Flanker Inhibitory Control test, with exploratory cardiovascular assessment by flow-mediated vasodilation. The study also measures sleep duration and depth, CPAP pressure and tolerance, hypoxia, patient symptoms, and biomarkers of neuronal damage, oxidative stress, and sympathetic activation to understand possible mechanisms. Enrollment and visits occur at Yale Centers for Sleep Medicine in North Haven, Connecticut.
Who should consider this trial
Good fit: Adults with a new clinical diagnosis of obstructive sleep apnea (AHI or REI ≥10/hour) who can give informed consent and do not have contraindications to eszopiclone or use of other sedative medications are ideal candidates.
Not a fit: People with central sleep disorders, significant neurological, neuromuscular, or pulmonary disorders, current use of other sedatives or heavy alcohol use, known hypersensitivity to eszopiclone, or a history of complex sleep behaviors are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, adding a short-acting hypnotic could improve CPAP adherence and associated cognitive and vascular outcomes by reducing disruptive awakenings.
How similar studies have performed: Small prior studies suggest hypnotics can raise arousal threshold and modify respiratory events, but large randomized trials showing improved CPAP adherence and cognition are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Able to provide informed consent. * Clinically confirmed new diagnosis of OSA: 1. Polysomnography AHI ≥ 10 per hour of sleep and/or 2. Home sleep apnea testing, respiratory even index, REI ≥ 10 per hour of recording Exclusion Criteria: * Known non-OSA related conditions associated with sleep-disordered breathing (e.g., a central disorder of hypersomnolence, neurological, neuromuscular, or pulmonary disorder) * Use of sleep-inducing medications (e.g., other non-benzodiazepine sedative hypnotic-drugs \[e.g., zoldpidem\], benzodiazepines, non-selective antihistamines, trazodone, opiates, barbituates) * Known hypersensitivity reaction to eszopiclone * Contraindications to its use based on medical history or function (e.g., dizziness at baseline or established mobility problems or imbalance) * History of complex sleep behaviors (e.g., NREM or REM parasomnias) * Concomitant use of ≥ 2 servings of alcohol per night or other CNS depressant for 2 weeks prior or throughout the study * Sleep opportunity of less than 7 hours * Severe active depression or other mental health disorders (e.g., schizophrenia, bipolar disorder, personality disorder). * History of sleep-walking, sleep-driving, and engaging in other activities while not fully awake * History of motor vehicle accidents related to sleepiness and/or motor vehicle "near misses" (e.g. sleepiness during driving or lane changes) * Severe hepatic impairment (liver function tests 2 X the upper limit of normal) * Unstable medical condition (e.g., decompensated heart failure, end-stage chronic obstructive pulmonary disease, end-stage renal disease) * Females of childbearing potential who are pregnant, breastfeeding, or intend to become pregnant, and women who are in the process of egg donation .
Where this trial is running
North Haven, Connecticut
- Yale Centers for Sleep Medicine — North Haven, Connecticut, United States (Recruiting)
Study contacts
- Principal investigator: Audrey Zinchuk,, MD, MHS — Yale University
- Study coordinator: Andrey Zinchuk, MD, MHS
- Email: andrey.zinchuk@yale.edu
- Phone: 475-655-6199
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.