Recruiting

CPAP

Sponsor:

University of Washington

Code:

NCT06722755

Conditions

Stroke Patients

CPAP

OSA - Obstructive Sleep Apnea

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CPAP device

CPAP technical support

Phone follow-up for adherence feedback and self-management skills

myAir

Tailored messages

Study Details

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.

Conditions

Stroke Patients

CPAP

OSA - Obstructive Sleep Apnea

Study ID

NCT06722755

Start date

Jan 15, 2025

Status verified date

Mar, 2026

Completion date

May, 2028

Anticipated

Primary completion date

Apr, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion criteria include:

1. Age 18 years or older
2. Head CT or brain MRI demonstrating an acute ischemic infarction or intraparenchymal hemorrhage within past 30 days
3. Person providing consent (patient or legally authorized representative (LAR)) able to be consented in English or Spanish.

Exclusion criteria include:

1. Unable to obtain informed consent from participant or LAR in English or Spanish
2. Incarcerated
3. Known pregnancy-determined by reviewing clinical data
4. Current mechanical ventilation, tracheostomy, or supplemental oxygen use > 4L/min
5. Use of positive airway pressure within 14 days prior to stroke
6. History of pneumothorax, bullous emphysema or other serious co-morbid conditions which limit CPAP use
7. Stroke related to tumors, vascular malformations or subarachnoid hemorrhage
8. Active use of sedative drugs that can interfere with testing for obstructive sleep apnea (OSA) including any benzodiazepine, barbiturate, general anesthesia, or conscious sedation within the prior 48 hours of the planned portable sleep apnea study
9. Anticipated inpatient rehabilitation length of stay < 5 nights
10. Co-morbid conditions that limit OSA testing or CPAP use in the judgement of the study team
11. Recent cranial or spinal surgery with known or possible CSF leak or pneumocephalus within past 3 months
12. Patients at significant risk of aspiration that could render the patient at risk of harm from use of CPAP, in the opinion of the site PI.

Study Design

Enrollment

250 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

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.

Interventions

CPAP device

Eligible participants with OSA will be started on automatically-adjusting CPAP.

CPAP technical support

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

The research coordinator will call participants approximately monthly to provide any needed support.

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.

Tailored messages

Tailored text messages will be sent to participants. Two-way texting messaging will also be available between the study team and participants.

Written Materials

A binder of written educational materials will be provided to participants.

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.

Primary outcome measure

  • CPAP Adherence [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Belqeis Abatiyow, BS

2067446067babatiyo@uw.edu

Sandeep Khot, MD, MPH

2067448028skhot@uw.edu

Locations

Rancho Research Institute

Recruiting

Downey, California, United States, 90242

Contacts

Jason Garcia

562-385-6939

University of Washington - Harborview Medical Center

Recruiting

Seattle, Washington, United States, 98104

Contacts

Belqeis Abatiyow, BS

2067446067babatiyo@uw.edu

More Information

Sponsor

University of Washington

Last update posted

Aug 13, 2026

Last verified

Mar, 2026

Keywords

  • behavioral therapy
  • continuous positive airway pressure
  • stroke recovery
  • self determination
  • sleep apnea

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Washington on 2026-08-13.