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

Study acronym: CALM-OSA
StatusRecruiting
PhasePhase 3
Started2026-05-18
View on ClinicalTrials.gov ↗

Amendment history

2026-06-01
Study Status v2
Start dateestimated 2026-05→confirmed 2026-05-18
2026-05-05
Study Status, Eligibility, Contacts/Locations v1
Recruitment opened
Start date2026-02→2026-05
Eligibility criteria+192 characters
[...] ing, 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 uppe [...] ho are pregnant, breastfeeding, or intend to become pregnant, and women who are in the process of egg donation .
Study sitesdetails revised at 1 of 1 site
2026-01-08
Original filing
Yale University
487 trials monitored
See 35 trials at risk
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.
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