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 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 250 participants in total. It began in 2025-01-15 with a primary completion date of 2028-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Contact & Investigator
Sandeep Khot, MD, MPH
PRINCIPAL INVESTIGATOR
University of Washington
Frequently Asked Questions
Who can join the NCT06722755 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Stroke Patients. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06722755 currently recruiting?
Yes, NCT06722755 is actively recruiting participants. Contact the research team at mca1@uw.edu for enrollment information.
Where is the NCT06722755 trial being conducted?
This trial is being conducted at Downey, United States, Seattle, United States.
Who is sponsoring the NCT06722755 clinical trial?
NCT06722755 is sponsored by University of Washington. The principal investigator is Sandeep Khot, MD, MPH at University of Washington. The trial plans to enroll 250 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.