NCT06722755 · University of Washington
Stroke and CPAP Outcome Study 3 Randomized Controlled Trial
(SCOUTS3)
What this study 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).
View original scientific description
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.
Interventions
DEVICE
CPAP device
Eligible participants with OSA will be started on automatically-adjusting CPAP.
BEHAVIORAL
CPAP technical support
Trained personnel will conduct mask selection and fitting, provide continual troubleshooting, and train participants on CPAP.
BEHAVIORAL
Phone follow-up for adherence feedback and self-management skills
The research coordinator will call participants approximately monthly to provide any needed support.
BEHAVIORAL
myAir
Study personnel will assist participants in registering for and using the myAir (ResMed) self-tracking app. This app also provides a library of how-to videos and provides email updates to participants.
BEHAVIORAL
Tailored messages
Tailored text messages will be sent to participants. Two-way texting messaging will also be available between the study team and participants.
BEHAVIORAL
Written Materials
A binder of written educational materials will be provided to participants.
BEHAVIORAL
Motivational Enhancement Therapy (MET)
A trained sleep coach will conduct up to 5 MET sessions with participants and 2 sessions with a CPAP partner during the study time period.
Primary outcome measures
CPAP Adherence
Time frame: 3 months
Average nightly minutes of CPAP use over the 90-day period is passively transmitted from a modem in each CPAP device via cellular service and securely accessed via the ResMed program, AirView. Alternatively, data cards can be obtained and downloaded.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- 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
- Use of positive airway pressure within 14 days prior to stroke
- History of pneumothorax, bullous emphysema or other serious co-morbid conditions which limit CPAP use
- Stroke related to tumors, vascular malformations or subarachnoid hemorrhage
- 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
- Anticipated inpatient rehabilitation length of stay \< 5 nights
- Co-morbid conditions that limit OSA testing or CPAP use in the judgement of the study team
- Recent cranial or spinal surgery with known or possible CSF leak or pneumocephalus within past 3 months
- 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.
Where
- Downey, California
- Seattle, Washington
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 30, 2026 · Source of record for eligibility and locations