NCT06722755 Stroke and CPAP Outcome Study 3 Randomized Controlled Trial
| NCT ID | NCT06722755 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Washington |
| Condition | Stroke Patients |
| Study Type | INTERVENTIONAL |
| Enrollment | 250 participants |
| Start Date | 2025-01-15 |
| Primary Completion | 2028-04 |
Trial Parameters
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Brief 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 Criteria
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 w
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