Continuous Positive Airway Pressure, Arousability and Links to Mechanisms in Obstructive Sleep Apnea
NCT07332442 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 250
Last updated 2026-05-06
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
Interventions
- DRUG
-
Eszopiclone
3mg for \< 65 and 2mg for ≥ 65 years
- DRUG
-
Matched placebo
Sponsors & Collaborators
-
National Heart, Lung, and Blood Institute (NHLBI)
collaborator NIH -
ResMed Foundation
collaborator OTHER -
Yale University
lead OTHER
Principal Investigators
-
Audrey Zinchuk,, MD, MHS · Yale University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- BASIC_SCIENCE
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-05-31
- Primary Completion
- 2030-01-31
- Completion
- 2030-06-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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