Intensive CPAP therapy for stroke patients with sleep apnea
Optimizing Adherence to the Treatment of Sleep Apnea Among Patients With Stroke Undergoing Inpatient Rehabilitation
This study is testing if extra support for using CPAP therapy can help stroke patients with sleep apnea recover better than standard care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Washington Academic / other |
| Locations | 2 sites (Downey, California and 1 other locations) |
| Trial ID | NCT06722755 on ClinicalTrials.gov |
What this trial studies
The SCOUTS 3 study evaluates the effectiveness of an intensive support program for Continuous Positive Airway Pressure (CPAP) therapy compared to standard care in stroke patients with obstructive sleep apnea (OSA) during their rehabilitation. This multicenter randomized controlled trial will recruit approximately 250 participants across two institutions, focusing on increasing CPAP adherence through a multicomponent behavioral intervention. Participants will be monitored for CPAP usage over a three-month period, with outcomes measured electronically. The study aims to determine if enhanced support can improve recovery outcomes for stroke patients with OSA.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have experienced an acute stroke within the past 30 days and have been diagnosed with obstructive sleep apnea.
Not a fit: Patients who are currently on mechanical ventilation, have serious co-morbid conditions, or have a history of certain respiratory issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve CPAP adherence and recovery outcomes for stroke patients with obstructive sleep apnea.
How similar studies have performed: Other studies have shown promising results with similar behavioral interventions for CPAP adherence, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Downey, California and 1 other locations
- Rancho Research Institute — Downey, California, United States (Recruiting)
- University of Washington - Harborview Medical Center — Seattle, Washington, United States (Recruiting)
Study contacts
- Principal investigator: Sandeep Khot, MD, MPH — University of Washington
- Study coordinator: Morgan Aurelio, DNP, MPH, ARNP-CNM
- Email: mca1@uw.edu
- Phone: 206-543-7589
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.