Continuous Positive Airway Pressure, Arousability and Links to Mechanisms in Obstructive Sleep Apnea
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorYale University
About this trial
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
Qualifiers
Able to provide informed consent.
Polysomnography AHI ≥ 10 per hour of sleep and/or
Home sleep apnea testing, respiratory even index, REI ≥ 10 per hour of recording
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Eszopiclone
- Placebo
Treatment groups
250 Participants
are divided into 2 treatment groupsSponsors and collaborators
Yale University
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
ResMed Foundation
Collaborator
Source ClinicalTrials.gov