Stroke and CPAP Outcome Study 3 Randomized Controlled Trial

ConditionsStroke Patients CPAP OSA - Obstructive Sleep Apnea

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

CPAP device
Device
Eligible participants with OSA will be started on automatically-adjusting CPAP.
CPAP technical support
Behavioral
Trained personnel will conduct mask selection and fitting, provide continual troubleshooting, and train participants on CPAP.
Phone follow-up for adherence feedback and self-management skills
Behavioral
The research coordinator will call participants approximately monthly to provide any needed support.
myAir
Behavioral
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.
Tailored messages
Behavioral
Tailored text messages will be sent to participants. Two-way texting messaging will also be available between the study team and participants.
Written Materials
Behavioral
A binder of written educational materials will be provided to participants.
Motivational Enhancement Therapy (MET)
Behavioral
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.

Treatment groups

250 Participants

are divided into 2 treatment groups

Group A: Intensive SupportExperimental treatment 7 interventions

Group B: Standard SupportActive comparator 1 intervention

Trial outcomes

Primary outcomes

CPAP Adherence

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.

Time frame

3 months

Secondary outcomes

Stroke recovery measure

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

Time frame

3 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Washington

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Source ClinicalTrials.gov

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