Stroke and CPAP Outcome Study 3 Randomized Controlled Trial

Not Applicable

Not yet recruiting

• Conditions: Stroke Patients; CPAP; OSA - Obstructive Sleep Apnea

• Registration Number: NCT06722755
• Lead Sponsor: University of Washington

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.

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-21
• Study First Submitted QC: 2024-12-03
• Last Update Submitted: 2024-12-03
• Study First Posted: 2024-12-09
• Last Update Posted: 2024-12-09
• Study Start: 2025-01-01
• Primary Completion: 2028-05-01
• Study Completion: 2028-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
CPAP Adherence	3 months	Average nightly minutes of CPAP use over the 90-day period is passively transmitted from a modem in each CPAP device via cellular service and securely accessed via the ResMed program, AirView. Alternatively, data cards can be obtained and downloaded.

Secondary Outcome Measures

Name	Time	Method
Stroke recovery measure	3 months	Functional disability (mRS-9Q) will be measured at \~90 days by phone \[range 0-5; higher scores indicate lower level of function in neurological disease\]

Trial Locations

Locations (2)

Rancho Research Institute; 🇺🇸 Downey, California, United States

University of Washington - Harborview Medical Center; 🇺🇸 Seattle, Washington, United States