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NCT04130503

The Recovery in Stroke Using PAP Study

Recruiting
NAAges 18+InterventionalTreatment
Yale University
~360 participants
Updated 2025-09-05 on ClinicalTrials.gov
What's tested:PAPHLE

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Modified Rankin Scale (mRS)
Measured over 6 months
+1 more outcome measured

Conditions

Ischemic Stroke
Obstructive Sleep Apnea

Explore related trials

Ischemic StrokeObstructive Sleep Apnea

Where it's being run

1 sites across 1 states
Connecticut1

Study leadership

  • Klar Yaggi, MD, MPH · PRINCIPAL_INVESTIGATOR · Yale University

Who to contact

Radu Radulescu, MD
[email protected]
2033614037
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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.

What this trial measures

  • Modified Rankin Scale (mRS)6 months

    The Modified Rankin Scale is a widely used measure of functional status and is sensitive to the full range of impairment from mild to severe. This objective examination scale with be video recorded by field staff and subsequently scored by the study neurologist blinded to randomization arm. The Modified Rankin Score (mRS) is a 6 point disability scale with possible scores ranging from 0 to 6. The higher the score, the more severe the disability. A score of 6 indicates the patient has expired (during the hospital stay or after discharge from the hospital).

  • Change in Katz ScaleRandomization date, 3 months, 6 months

    The Katz Index of Independence in Activities of Daily Living (KatzADL), is the most appropriate instrument to assess functional status as a measurement of the client's ability to perform Activities of Daily Living independently. The Index ranks adequacy of performance in the 6 functions of bathing, dressing, toileting, transferring, continence, and feeding. Clients are scored yes/no for independence in each of the 6 functions. A score of 6 indicates full function, 4 indicates moderate impairment, and 2 or less indicates severe functional impairment