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

RecruitingPhase 3

Sponsor: Yale University

Conditions: Sleep Apnea, Obstructive Sleep Apnea

Interventions: Eszopiclone, Placebo

Countries: United States

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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 .

Locations (1)

North Haven, Connecticut, United States