Stroke and CPAP Outcome Study 3 Randomized Controlled Trial

Part of paid clinical trials in Downey, California.

Sponsor
University of Washington
Study ID
NCT06722755
Status
Recruiting
Apply to this trial

Conditions

  • CPAP
  • OSA - Obstructive Sleep Apnea
  • Stroke Patients

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Jan 15, 2025
Status verified
Mar 2026
Primary completion
Apr 30, 2028
Completion
May 31, 2028

Study Design

Enrollment
250 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Intensive Support
    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.
  • Active Comparator: Standard Support
    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.

Primary Outcome Measure

CPAP Adherence [ Time Frame: 3 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Rancho Research InstituteDowneyCalifornia90242
Jason Garcia
562-385-6939
University of Washington - Harborview Medical CenterSeattleWashington98104
Morgan Aurelio, DNP, MPH, ARNP-CNM
[email protected]
206-543-7589

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By research site
Rancho Research Institute· Downey, CAUniversity of Washington - Harborview Medical Center· Seattle, WA

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