Recruiting

PAP

Sponsor:

Yale University

Code:

NCT04130503

Conditions

Ischemic Stroke

Obstructive Sleep Apnea

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

PAP

HLE

Study Details

Brief 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.

Conditions

Ischemic Stroke

Obstructive Sleep Apnea

Study ID

NCT04130503

Start date

Sep 1, 2019

Status verified date

Aug, 2025

Completion date

Oct, 2025

Anticipated

Primary completion date

Oct, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 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.

Study Design

Enrollment

360 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: PAP treatment- Acute

Acute intervention patients will start PAP within 1-week poststroke symptom onset, and subacute patients will start PAP 1-month post-symptom onset. Both groups will continue PAP therapy through the duration of the study, reinforced with technical assistance and behavioral support.

All patients (randomized and non-randomized) will receive a healthy lifestyle education (HLE) intervention focused on secondary stroke prevention, as well as interim contacts occurring at 1 week, 1 month, and 3 months, post-randomization, where outcome measures and safety assessments will occur.

active comparator: Usual Care (HLE)

All patients (randomized and non-randomized) will receive a healthy lifestyle education (HLE) intervention focused on secondary stroke prevention, as well as interim contacts occurring at 1 week, 1 month, and 3 months, post-randomization, where outcome measures and safety assessments will occur.

experimental: PAP treatment- Subacute

Acute intervention patients will start PAP within 1-week poststroke symptom onset, and subacute patients will start PAP 1-month post-symptom onset. Both groups will continue PAP therapy through the duration of the study, reinforced with technical assistance and behavioral support.

All patients (randomized and non-randomized) will receive a healthy lifestyle education (HLE) intervention focused on secondary stroke prevention, as well as interim contacts occurring at 1 week, 1 month, and 3 months, post-randomization, where outcome measures and safety assessments will occur.

other: Exploratory arm

Non-randomized comparison/exploratory group of subjects with ischemic stroke and Apnea-Hypopnea Index (AHI) <15 (approximately 120 participants) and approximately 60 subjects with ICH (who do not need legally authorized representative for consent - most likely mild form of ICH) and any level of AHI.

Interventions

PAP

Positive airway pressure (PAP) treatment of obstructive sleep apnea (OSA).

HLE

All patients (randomized and non-randomized) will receive a healthy lifestyle education (HLE) intervention focused on secondary stroke prevention.

Primary outcome measure

  • Modified Rankin Scale (mRS) [ Time Frame: 6 months ]
  • Change in Katz Scale [ Time Frame: Randomization date, 3 months, 6 months ]

Central Contacts and Locations

Central contacts

Radu Radulescu, MD

2033614037radu.radulescu@yale.edu

Locations

Yale University

Recruiting

New Haven, Connecticut, United States, 06519

Contacts

Klar Yaggi, MD

203-209-4274henry.yaggi@yale.edu

More Information

Sponsor

Yale University

Last update posted

Sep 5, 2025

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Yale University on 2025-09-05.