Tests PAP breathing device in stroke patients with sleep apnea
Tests a breathing machine against usual care in adults with stroke and sleep apnea.
Plain-language title generated from the registry record
Registry title: The Recovery in Stroke Using PAP Study
Key facts
- Where
- New Haven, United StatesSee the site
Where in United States
- Yale UniversityNew Haven, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Yale University
- Trial code
- NCT04130503
- Record updated
- 5 September 2025
- Original description
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.Read full original descriptionShow less
The Recovery in Stroke Using PAP Study
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.
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: 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; Suspected sleep disorder other than OSA (e.g., narcolepsy) (because such patients should be referred for a formal PSG in a sleep laboratory); 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%.