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Stroke and CPAP Outcome Study 3 Randomized Controlled Trial (SCOUTS3 Trial)

N/A

Waitlist Available

Led By Devin Brown, MD, MS

Research Sponsored by University of Washington

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

1. Age 18 years or older

2. Head CT or brain MRI demonstrating an acute ischemic infarction or intraparenchymal hemorrhage within past 30 days

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

No Placebo-Only Group

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.

Eligible Conditions

Obstructive Sleep Apnea
CPAP
Stroke

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

CPAP Adherence

Secondary study objectives

Stroke recovery measure

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intensive SupportExperimental Treatment7 Interventions

The Intensive Support (IS) group will receive the multicomponent intensive behavioral adherence program, which includes a CPAP technical support intervention, Motivational Enhancement Therapy (MET), and a Mobile Health intervention. Participants assigned to the IS group will also receive the 3 basic supportive treatments, including OSA and CPAP education, respiratory therapy and nursing support during inpatient rehabilitation, and referral to a DME company after inpatient rehabilitation discharge if needed.

Group II: Standard SupportActive Control1 Intervention

Participants assigned to the control group will receive only the 3 basic supportive treatments, including OSA and CPAP education, respiratory therapy and nursing support during inpatient rehabilitation, and referral to a DME company after study completion if needed. CPAP will be set up by the respiratory therapist (or similar personnel) on the inpatient rehabilitation (IPR) unit with standard mask fitting and troubleshooting, if available. Assistance with mask placement will be provided by IPR nurses and respiratory therapy, as needed. The control interventions mimic usual care, which typically entails a setup by respiratory therapy and support for CPAP placement and device maintenance by IPR nurses.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Motivational Enhancement Therapy (MET)

2008

Completed Phase 3

~1510

Written Materials

2010

N/A

~1190