Recruiting
Phase 3

Ezbopiclone with CPAP

Sponsor:

Yale University

Code:

NCT07332442

Conditions

Sleep Apnea

Obstructive Sleep Apnea

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Eszopiclone

Placebo

Study Details

Brief summary:

The study design is a randomized, controlled clinical trial to test the hypothesis that arousal threshold (ArTH) will affect how individuals with obstructive sleep apnea (OSA, Apnea-Hypopnea Index (AHI) of 10/hour of higher) respond to CPAP therapy regarding adherence and cognitive function (executive function). Investigators hypothesize that raising ArTH with eszopiclone will improve adherence to CPAP and neurocognitive function with CPAP therapy. Investigators also hypothesize that a lower baseline ArTH is associated with worse CPAP adherence, while a higher baseline ArTH is associated with improved neurocognitive outcomes with CPAP therapy.

Conditions

Sleep Apnea

Obstructive Sleep Apnea

Study ID

NCT07332442

Start date

May 18, 2026

Status verified date

Jun, 2026

Completion date

Jun, 2030

Anticipated

Primary completion date

Jan, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 .

Study Design

Enrollment

250 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Eszopiclone

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

placebo comparator: Placebo

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

Interventions

Eszopiclone

3mg for < 65 and 2mg for ≥ 65 years

Placebo

Matched placebo

Primary outcome measure

  • CPAP adherence [ Time Frame: Daily over 3 months ]
  • Flanker inhibitory control and attention test [ Time Frame: Baseline, 1-, 2- and 3-months ]

Central Contacts and Locations

Central contacts

Andrey Zinchuk, MD, MHS

475-655-6199andrey.zinchuk@yale.edu

Iouri Kreinin, MD

iouri.kreinin@yale.edu

Locations

Yale Centers for Sleep Medicine

Recruiting

North Haven, Connecticut, United States, 06347

More Information

Sponsor

Yale University

Last update posted

Jun 3, 2026

Last verified

Jun, 2026

Keywords

  • Continuous Positive Airway Pressure (CPAP)
  • sleep apnea
  • hypnotic
  • mechanism
  • arousability

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Yale University on 2026-06-03.