NCT07332442 Continuous Positive Airway Pressure, Arousability and Links to Mechanisms in Obstructive Sleep Apnea
| NCT ID | NCT07332442 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Yale University |
| Condition | Sleep Apnea |
| Study Type | INTERVENTIONAL |
| Enrollment | 250 participants |
| Start Date | 2026-05-18 |
| Primary Completion | 2030-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 250 participants in total. It began in 2026-05-18 with a primary completion date of 2030-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * Able to provide informed consent. * Clinically confirmed new diagnosis of OSA: 1. Polysomnography AHI ≥ 10 per hour of sleep and/or 2. Home sleep apnea testing, respiratory even index, REI ≥ 10 per hour of recording Exclusion Criteria: * Known non-OSA related conditions associated with sleep-disordered breathing (e.g., a central disorder of hypersomnolence, neurological, neuromuscular, or pulmonary disorder) * Use of sleep-inducing medications (e.g., other non-benzodiazepine sedative hypnotic-drugs \[e.g., zoldpidem\], benzodiazepines, non-selective antihistamines, trazodone, opiates, barbituates) * Known hypersensitivity reaction to eszopiclone * Contraindications to its use based on medical history or function (e.g., dizziness at baseline or established mobility problems or imbalance) * History of complex sleep behaviors (e.g., NREM or REM parasomnias) * Concomitant use of ≥ 2 servings of alcohol per night or other CNS depressant for 2 weeks prior or throughout the study * Sleep opportunity of less than 7 hours * Severe active depression or other mental health disorders (e.g., schizophrenia, bipolar disorder, personality disorder). * History of sleep-walking, sleep-driving, 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 upper limit of normal) * Unstable medical condition (e.g., decompensated heart failure, end-stage chronic obstructive pulmonary disease, end-stage renal disease) * Females of childbearing potential who are pregnant, breastfeeding, or intend to become pregnant, and women who are in the process of egg donation .
Contact & Investigator
Audrey Zinchuk,, MD, MHS
PRINCIPAL INVESTIGATOR
Yale University
Frequently Asked Questions
Who can join the NCT07332442 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Sleep Apnea. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07332442 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 250 participants.
Is NCT07332442 currently recruiting?
Yes, NCT07332442 is actively recruiting participants. Contact the research team at andrey.zinchuk@yale.edu for enrollment information.
Where is the NCT07332442 trial being conducted?
This trial is being conducted at North Haven, United States.
Who is sponsoring the NCT07332442 clinical trial?
NCT07332442 is sponsored by Yale University. The principal investigator is Audrey Zinchuk,, MD, MHS at Yale University. The trial plans to enroll 250 participants.