Stroke and CPAP Outcome Study 3 Randomized Controlled Trial
Optimizing Adherence to the Treatment of Sleep Apnea Among Patients With Stroke Undergoing Inpatient Rehabilitation
University of Washington
250 participants
Jan 15, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria3
- 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 Criteria12
- 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.
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Interventions
Eligible participants with OSA will be started on automatically-adjusting CPAP.
Trained personnel will conduct mask selection and fitting, provide continual troubleshooting, and train participants on CPAP.
The research coordinator will call participants approximately monthly to provide any needed support.
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.
Tailored text messages will be sent to participants. Two-way texting messaging will also be available between the study team and participants.
A binder of written educational materials will be provided to participants.
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.
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT06722755