Stroke and CPAP Outcome Study 3 Randomized Controlled Trial

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.

Conditions

• Stroke Patients
• CPAP
• OSA - Obstructive Sleep Apnea

Interventions

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.

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• University of Washington

  lead OTHER

Principal Investigators

• Sandeep Khot, MD, MPH · University of Washington

• Devin Brown, MD, MS · University of Michigan

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-01-15

Primary Completion

2028-04-30

Completion

2028-05-31

FDA Device

Yes

Countries

• United States

Study Locations