Stroke and CPAP Outcome Study 3 Randomized Controlled Trial

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Washington

About this trial

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

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • CPAP device
  • CPAP technical support
  • Phone follow-up for adherence feedback and self-management skills
  • myAir
  • Tailored messages
  • Written Materials
  • Motivational Enhancement Therapy (MET)

Treatment groups

250 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of Washington

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator