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

Part of paid clinical trials in North Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT07332442
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Eszopiclone — DRUG
    3mg for \< 65 and 2mg for ≥ 65 years
  • Placebo — DRUG
    Matched placebo

Study Details

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.

Key Dates

Start date
May 18, 2026
Status verified
Jun 2026
Primary completion
Jan 31, 2030
Completion
Jun 30, 2030

Study Design

Enrollment
250 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

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

Primary Outcome Measure

CPAP adherence [ Time Frame: Daily over 3 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Yale Centers for Sleep MedicineNorth HavenConnecticut06347-

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By research site
Yale Centers for Sleep Medicine· North Haven, CT

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