Actively Recruiting
Continuous Positive Airway Pressure, Arousability and Links to Mechanisms in Obstructive Sleep Apnea
Led by Yale University · Updated on 2026-06-03
250
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
Sponsors
Y
Yale University
Lead Sponsor
N
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying adults with obstructive sleep apnea (OSA) who have an Apnea-Hypopnea Index (AHI) of 10 or higher per hour of sleep. The study aims to find out if raising the arousal threshold (ArTH) using eszopiclone affects how well people stick to continuous positive airway pressure (CPAP) therapy and improve cognitive functions like attention and executive control. The study also explores how baseline arousal threshold levels may relate to CPAP adherence and neurocognitive outcomes. Participants will be randomly assigned to receive either eszopiclone or a placebo on the night of a split-night polysomnography test, which monitors sleep with and without CPAP therapy. After this laboratory night, they will continue to take eszopiclone or placebo along with CPAP therapy over three months. The eszopiclone dose is 3 mg for those under 65 years and 2 mg for those 65 and older. The study uses a quadruple masking design to compare the effects. During the study, participants will have daily CPAP adherence tracked for three months and undergo several cognitive tests including the Flanker Inhibitory Control test at baseline and monthly intervals. Researchers will also measure cardiovascular function, sleep quality, hypoxia levels, and biomarkers related to neuronal damage and stress at various times. Safety and tolerance to treatment will be monitored, with assessments continuing through the study duration of up to three months.
CONDITIONS
Brief Title
Continuous Positive Airway Pressure, Arousability and Links to Mechanisms in Obstructive Sleep Apnea
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to provide informed consent
- New clinical diagnosis of obstructive sleep apnea confirmed by
- Polysomnography showing Apnea-Hypopnea Index (AHI) of 10 or higher per hour of sleep and/or
- Home sleep apnea testing with a respiratory event index (REI) of 10 or higher per hour of recording
- Adults aged 18 years or older
You will not qualify if you...
- Known sleep-disordered breathing conditions not related to OSA such as central hypersomnolence, neurological, neuromuscular, or pulmonary disorders
- Use of sleep-inducing medications like benzodiazepines, non-benzodiazepine sedatives, antihistamines, trazodone, opiates, or barbiturates
- Known allergy or hypersensitivity to eszopiclone
- Medical history or conditions that contraindicate eszopiclone use, including dizziness or mobility problems
- History of complex sleep behaviors such as parasomnias (NREM or REM)
- Use of two or more servings of alcohol per night or other CNS depressants within two weeks before or during the study
- Less than 7 hours of sleep opportunity
- Severe active depression or serious mental health disorders like schizophrenia, bipolar disorder, or personality disorders
- History of sleepwalking, sleep-driving, or other activities while not fully awake
- History of motor vehicle accidents related to sleepiness or near misses
- Severe liver impairment (liver tests twice above normal limits)
- Unstable medical conditions such as decompensated heart failure, end-stage lung or kidney disease
- Women who are pregnant, breastfeeding, intend to become pregnant, or undergoing egg donation
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 months
Participants receive either eszopiclone or a placebo on the night of a polysomnography sleep study and continue with the assigned drug along with CPAP therapy.
Daily adherence monitoring and assessments at baseline, 1, 2, and 3 months
Trial Site Locations
Total: 1 location
1
Yale Centers for Sleep Medicine
North Haven, Connecticut, United States, 06347
Actively Recruiting
Research Team
A
Andrey Zinchuk, MD, MHS
I
Iouri Kreinin, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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