Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT07332442

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

Led by Yale University · Updated on 2026-05-06

250

Participants Needed

1

Research Sites

213 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

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Able to provide informed consent
  • New clinical diagnosis of obstructive sleep apnea confirmed by sleep test showing AHI or REI of 10 or more per hour
Not Eligible

You will not qualify if you...

  • Known non-OSA related sleep-disordered breathing conditions such as central hypersomnolence or neurological, neuromuscular, or pulmonary disorders
  • Use of sleep-inducing medications like benzodiazepines, zolpidem, non-selective antihistamines, trazodone, opiates, or barbiturates
  • Known allergy or hypersensitivity to eszopiclone
  • Medical history or conditions that contraindicate eszopiclone use, including dizziness or balance problems
  • History of complex sleep behaviors such as parasomnias
  • Consuming two or more servings of alcohol per night or other CNS depressants within two weeks before or during the study
  • Sleeping less than 7 hours per night
  • Severe active depression or major mental health disorders like schizophrenia or bipolar disorder
  • History of sleep-walking, sleep-driving, or other activities while not fully awake
  • History of sleepiness-related motor vehicle accidents or near misses
  • Severe liver impairment with elevated liver function tests
  • Unstable medical conditions such as decompensated heart failure or end-stage lung or kidney disease
  • Women of childbearing potential who are pregnant, breastfeeding, planning pregnancy, or donating eggs

AI-Screening

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Trial Site Locations

Total: 1 location

1

Yale Centers for Sleep Medicine

North Haven, Connecticut, United States, 06347

Actively Recruiting

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Research Team

A

Andrey Zinchuk, MD, MHS

CONTACT

I

Iouri Kreinin, MD

CONTACT

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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