The Recovery in Stroke Using PAP Study

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.

Conditions

Ischemic Stroke, Obstructive Sleep Apnea

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Study Overview

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Study Details

Study overview

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.

The Recovery in Stroke Using PAP Study

The Recovery in Stroke Using PAP Study

Condition
Ischemic Stroke
Intervention / Treatment

-

Contacts and Locations

New Haven

Yale University, New Haven, Connecticut, United States, 06519

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Yale University,

Klar Yaggi, MD, MPH, PRINCIPAL_INVESTIGATOR, Yale University

Study Record Dates

2024-12-31