Continuous Positive Airway Pressure, Arousability and Links to Mechanisms in Obstructive Sleep Apnea
Recruiting
Phase 3
Interventional Study
Sleep Apnea
Obstructive Sleep Apnea
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Basic Science
- Participants needed
- 250 (estimated)
- Sponsor
- Yale University · Other
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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…
Trial Locations
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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…
Contacts