NCT04130503Recruiting
The Recovery in Stroke Using PAP Study
Source: ClinicalTrials.gov · Last updated 5 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 360 (estimated)
- First submitted
- 16 Oct 2019
- Start date
- 1 Sept 2019
- Primary completion date
- 31 Oct 2025
- Lead sponsor
- Yale University
- Diseases
- Stroke
- NCT number
- NCT04130503
What you commit to
- Study type: Interventional
- Planned participants: 360
- From 1 Sept 2019 to the primary completion date, 31 Oct 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Lab values
- Suspected sleep disorder other than OSA (e.g., narcolepsy) (because such patients should be referred for a formal PSG in a sleep laboratory);
Other
- Past use of prescribed PAP for OSA;
- 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%.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Yale University Coordinator of this site? Confirm its status | New Haven | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.