The Recovery in Stroke Using PAP Study
Recruiting now · Not applicable
Conditions studied: Ischemic Stroke, Obstructive Sleep Apnea
In brief
The proposed study is a randomized controlled trial among an anicipated 180 participants with acute ischemic stroke and mod/severe OSA diagnosed by ambulatory polysomnography (PSG) comparing PAP treatment with usual care concerning the primary outcome of functional recovery.
Key facts
- Study ID
- NCT04130503
- Run by
- Yale University
- People needed
- 360
- Starts
- 2019-09-01
- Expected to finish
- 2025-10-01
- Last updated by the study team
- 2025-09-05
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Having an acute ischemic stroke with brain imaging within 48 hours of symptoms onset;
- Being within 5 days of neurologic symptoms onset;
- Moderate (15 =< overall AHI < 30) /severe (overall AHI >= 30) OSA, thus with an obstructive apnea-hypopnea index AHI >= 15.
You may not qualify if…
- Past use of prescribed PAP for OSA;
- Suspected sleep disorder other than OSA (e.g., narcolepsy) (because such patients should be referred for a formal PSG in a sleep laboratory);
- Life expectancy is less than 6 months (e.g., hospice patients);
- Patients who require mechanical ventilation (because such patients could not participate in the intervention protocol);
- Non-English language patients (because the intervention strategy involves forming a relationship between the patient and research staff);
- Central sleep apnea with > 50% of respiratory events classified as central apnea;
- Resting oxygen saturation < 90%.
- Inability to provide their own informed consent. To enhance the generalizability of our study, all stroke severity will be included. However, we will exclude patients who cannot provide their own consent. This is because patients will need to participate actively in the protocol with a behavioral intervention. An assessment of the patient's competence to provide consent will be made based on published recommendations.
Where it is running
- Yale University — New Haven, Connecticut, United States (enrolling)
Full record on ClinicalTrials.gov
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