The Recovery in Stroke Using PAP Study
Yale University
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 treatment with usual care concerning the primary outcome of functional recovery.
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, post-stroke functional recovery (primary outcome), and quality of life. Specific aim 2 or Aim D: Determine whether acute vs. subacute initiation of PAP in ischemic stroke results in greater improvement in post-stroke outcomes (stroke severity, symptoms, stroke recovery, quality of life). Specific Aim 3 or Aim B: Conduct in-depth qualitative interviews with 25-30 stroke patients, family members, an…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 Criteria: * 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 venti…
Interventions
- DevicePAP
Positive airway pressure (PAP) treatment of obstructive sleep apnea (OSA).
- BehavioralHLE
All patients (randomized and non-randomized) will receive a healthy lifestyle education (HLE) intervention focused on secondary stroke prevention.
Location
- Yale UniversityNew Haven, Connecticut