Status:
RECRUITING
The Recovery in Stroke Using PAP Study
Lead Sponsor:
Yale University
Collaborating Sponsors:
Hartford HealthCare
National Institute of Nursing Research (NINR)
Conditions:
Ischemic Stroke
Obstructive Sleep Apnea
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 treat...
Detailed Description
This study has 4 aims: 3 main aims and an additional exploratory aim. Specific aim 1 or Aim A: Test whether PAP treatment for OSA in ischemic stroke improves stroke severity, post-stroke symptoms, po...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
September 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2025
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT04130503
Start Date
September 1 2019
End Date
October 1 2025
Last Update
September 5 2025
Active Locations (1)
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1
Yale University
New Haven, Connecticut, United States, 06519