NCT06722755Recruiting
Stroke and CPAP Outcome Study 3 Randomized Controlled Trial
Optimizing Adherence to the Treatment of Sleep Apnea Among Patients With Stroke Undergoing Inpatient Rehabilitation
Source: ClinicalTrials.gov · Last updated 13 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 250 (estimated)
- First submitted
- 21 Nov 2024
- Start date
- 15 Jan 2025
- Primary completion date
- Apr 2028
- Lead sponsor
- University of Washington
- Diseases
- Stroke
- NCT number
- NCT06722755
What you commit to
- Study type: Interventional
- Planned participants: 250
- From 15 Jan 2025 to the primary completion date, Apr 2028
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of positive airway pressure within 14 days prior to stroke
- 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
- Recent cranial or spinal surgery with known or possible CSF leak or pneumocephalus within past 3 months
Other illness
- History of pneumothorax, bullous emphysema or other serious co-morbid conditions which limit CPAP use
- Stroke related to tumors, vascular malformations or subarachnoid hemorrhage
- Co-morbid conditions that limit OSA testing or CPAP use in the judgement of the study team
Other
- Unable to obtain informed consent from participant or LAR in English or Spanish
- Incarcerated
- Known pregnancy-determined by reviewing clinical data
- Current mechanical ventilation, tracheostomy, or supplemental oxygen use \> 4L/min
- Anticipated inpatient rehabilitation length of stay \< 5 nights
- 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.
Who the study is looking for
- Age 18 years or older
- Head CT or brain MRI demonstrating an acute ischemic infarction or intraparenchymal hemorrhage within past 30 days
- Person providing consent (patient or legally authorized representative (LAR)) able to be consented in English or Spanish.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Rancho Research Institute Coordinator of this site? Confirm its status | Downey | United States | Recruiting |
| University of Washington - Harborview Medical Center Coordinator of this site? Confirm its status | Seattle | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.