Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06722755

Stroke and CPAP Outcome Study 3 Randomized Controlled Trial

Led by University of Washington · Updated on 2026-03-30

250

Participants Needed

2

Research Sites

171 weeks

Total Duration

On this page

Sponsors

U

University of Washington

Lead Sponsor

N

National Heart, Lung, and Blood Institute (NHLBI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

The SCOUTS 3 study aims to test the effectiveness of an intensive CPAP (Continuous Positive Airway Pressure) therapy support program compared to usual care in stroke patients with obstructive sleep apnea (OSA) during inpatient rehabilitation (IPR). The study is a multicenter randomized controlled trial (RCT) involving recruitment of about 250 participants across two institutions and randomization of about 200 participants. It compares an intensive support (IS) program for CPAP use with standard support (SS) to evaluate the effectiveness of the IS intervention in increasing CPAP usage during and after stroke rehabilitation. The Intensive Support (IS) group will receive a multicomponent intensive behavioral adherence program, which includes a CPAP technical support intervention, Motivational Enhancement Therapy (MET), and a Mobile Health intervention. Outcomes measured include CPAP adherence as measured by average nightly use in minutes between randomization and 3 months and the modified Rankin Scale (mRS-9Q) to evaluate stroke recovery.

CONDITIONS

Official Title

Stroke and CPAP Outcome Study 3 Randomized Controlled Trial

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Acute ischemic infarction or intraparenchymal hemorrhage confirmed by head CT or brain MRI within the past 30 days
  • Ability to provide consent in English or Spanish by participant or legally authorized representative
Not Eligible

You will not qualify if you...

  • Unable to provide informed consent in English or Spanish by participant or legal representative
  • Currently incarcerated
  • Known pregnancy
  • Current use of mechanical ventilation, tracheostomy, or supplemental oxygen over 4 liters per minute
  • Use of positive airway pressure within 14 days before stroke
  • History of pneumothorax, bullous emphysema, or serious conditions limiting CPAP use
  • Stroke caused by tumors, vascular malformations, or subarachnoid hemorrhage
  • Use of sedative drugs like benzodiazepines, barbiturates, general anesthesia, or conscious sedation within 48 hours before sleep apnea testing
  • Expected inpatient rehabilitation stay less than 5 nights
  • Other health conditions limiting OSA testing or CPAP use as judged by study team
  • Recent cranial or spinal surgery with possible cerebrospinal fluid leak or pneumocephalus within past 3 months
  • Significant risk of aspiration that could cause harm from CPAP use as judged by the site principal investigator

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 2 locations

1

Rancho Research Institute

Downey, California, United States, 90242

Actively Recruiting

2

University of Washington - Harborview Medical Center

Seattle, Washington, United States, 98104

Actively Recruiting

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Research Team

M

Morgan Aurelio, DNP, MPH, ARNP-CNM

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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