Intensive CPAP therapy for stroke patients with sleep apnea

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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: Belqeis Abatiyow, BS
• Email: babatiyo@uw.edu
• Phone: 2067446067

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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• CPAP pressure equations versus sleep‑lab manual titration in Thai adults with obstructive sleep apnea

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.