Home › Obstructive Sleep Apnea › NCT06722755

Stroke and CPAP Outcome Study 3 Randomized Controlled Trial

Optimizing Adherence to the Treatment of Sleep Apnea Among Patients With Stroke Undergoing Inpatient Rehabilitation

Who can join

Ages 18 and older · All sexes

Inclusion criteria include:

1. Age 18 years or older
2. Head CT or brain MRI demonstrating an acute ischemic infarction or intraparenchymal hemorrhage within past 30 days
3. Person providing consent (patient or legally authorized representative (LAR)) able to be consented in English or Spanish.

Exclusion criteria include:

1. Unable to obtain informed consent from participant or LAR in English or Spanish
2. Incarcerated
3. Known pregnancy-determined by reviewing clinical data
4. Current mechanical ventilation, tracheostomy, or supplemental oxygen use \> 4L/min
5. Use of positive airway pressure within 14 days prior to stroke
6. History of pneumothorax, bullous emphysema or other serious co-morbid conditions which limit CPAP use
7. Stroke related to tumors, vascular malformations or subarachnoid hemorrhage
8. Active use of sedative drugs that can interfere with testing for obstructive sleep apnea (OSA) including any benzodiazepine, barbiturate, general anesthesia, or conscious sedation within the prior 48 hours of the planned portable sleep apnea study
9. Anticipated inpatient rehabilitation length of stay \< 5 nights
10. Co-morbid conditions that limit OSA testing or CPAP use in the judgement of the study team
11. Recent cranial or spinal surgery with known or possible CSF leak or pneumocephalus within past 3 months
12. Patients at significant risk of aspiration that could render the patient at risk of harm from use of CPAP, in the opinion of the site PI.

About the study

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.

What is being tested

• CPAP device (device)
• CPAP technical support (behavioral)
• Phone follow-up for adherence feedback and self-management skills (behavioral)
• myAir (behavioral)
• Tailored messages (behavioral)
• Written Materials (behavioral)

Sponsor: University of Washington · Participants: 250 · Started: Jan 15, 2025

Contact the study team

• Belqeis Abatiyow, BS · Phone: 2067446067
• Sandeep Khot, MD, MPH · Phone: 2067448028

Official record on ClinicalTrials.gov — NCT06722755

Locations in the U.S.

Conditions

• Obstructive Sleep Apnea
• Sleep Apnea

From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.