Using a sleep medication to help people with obstructive sleep apnea tolerate CPAP

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.