Clinical Trial

Continuous Positive Airway Pressure, Arousability and Links to Mechanisms in Obstructive Sleep Apnea

Study acronym: CALM-OSA
Recruiting Phase 3
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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.
Protocol Amendment History 1 change
critical Recruitment opened 2026-05-07
Trial Details
NCT Number NCT07332442
Lead Sponsor Yale University
Collaborators: National Heart, Lung, and Blood Institute (NHLBI), ResMed Foundation
Conditions Sleep Apnea, Obstructive Sleep Apnea
Enrollment 250 participants
Start Date 2026-05-18
Primary Completion 2030-01 (estimated)
Study Completion 2030-06 (estimated)
Updated on ClinicalTrials.gov 2026-06-03