NCT06722755

Stroke and CPAP Outcome Study 3 Randomized Controlled Trial

Optimizing Adherence to the Treatment of Sleep Apnea Among Patients With Stroke Undergoing Inpatient Rehabilitation

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Within an investigator-initiated, phase 2 multicenter randomized controlled trial, we will test the effect of the multicomponent behavioral adherence intervention on 3-months of CPAP use among stroke patients with obstructive sleep apnea (OSA) and continuous positive airway pressure (CPAP) therapy initiated during inpatient rehabilitation (IPR). The study will be conducted at 2 IPR centers, University of Washington (UW) in Seattle, WA., and Rancho Los Amigos National Rehabilitation Center (RLANRC) in Los Angeles, CA. Over a \~3-year period, adult patients recovering from acute stroke within the past 30 days will be recruited upon IPR admission to these centers and tested for OSA through a simple, portable cardiorespiratory study with automated software. Eligible participants with OSA will be randomized to CPAP plus: either the adapted adherence intervention or control. All randomized subjects will be treated with auto-titrating CPAP or aCPAP. CPAP use will be measured electronically. Both groups will continue CPAP for a 3-month treatment period. We anticipate enrolling approximately 250 participants over the \~3 years of recruitment to randomize 200 eligible participants. The primary endpoint will be the average nightly minutes of CPAP use over the 90-day period, objectively measured, and the secondary outcome will be the Modified Rankin Scale-9 questions assessed at 3 months by phone.

Conditions

• Stroke Patients
• CPAP
• OSA - Obstructive Sleep Apnea

Interventions

Type	Name	Description
DEVICE	CPAP device	Eligible participants with OSA will be started on automatically-adjusting CPAP.
BEHAVIORAL	CPAP technical support	Trained personnel will conduct mask selection and fitting, provide continual troubleshooting, and train participants on CPAP.
BEHAVIORAL	Phone follow-up for adherence feedback and self-management skills	The research coordinator will call participants approximately monthly to provide any needed support.
BEHAVIORAL	myAir	Study personnel will assist participants in registering for and using the myAir (ResMed) self-tracking app. This app also provides a library of how-to videos and provides email updates to participants.
BEHAVIORAL	Tailored messages	Tailored text messages will be sent to participants. Two-way texting messaging will also be available between the study team and participants.
BEHAVIORAL	Written Materials	A binder of written educational materials will be provided to participants.
BEHAVIORAL	Motivational Enhancement Therapy (MET)	A trained sleep coach will conduct up to 5 MET sessions with participants and 2 sessions with a CPAP partner during the study time period.

Timeline

• Start date: 2025-01-15
• Primary completion: 2028-04-01
• Completion: 2028-05-01
• First posted: 2024-12-09
• Last updated: 2026-03-30

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study