Find Obstructive Sleep Apnea Clinical Trials Near You
Continuous Positive Airway Pressure, Arousability and Links to Mechanisms in Obstructive Sleep Apnea
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Able to provide informed consent.
• Clinically confirmed new diagnosis of OSA:
‣ Polysomnography AHI ≥ 10 per hour of sleep and/or
⁃ Home sleep apnea testing, respiratory even index, REI ≥ 10 per hour of recording
Locations
United States
Connecticut
Yale Centers for Sleep Medicine
RECRUITING
North Haven
Contact Information
Primary
Andrey Zinchuk, MD, MHS
andrey.zinchuk@yale.edu
475-655-6199
Backup
Iouri Kreinin, MD
iouri.kreinin@yale.edu
Time Frame
Start Date:2026-05-18
Estimated Completion Date:2030-06
Participants
Target number of participants:250
Treatments
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