Stroke and CPAP Outcome Study 3 Randomized Controlled Trial

NCT06722755 | Recruiting DMC FDA Device

• 2 other identifiers: STUDY00021430R01HL164394-01A1
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 2

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months

Secondary Outcomes (1)

• Stroke recovery measure

  3 months

Study Arms (2)

Intensive Support

EXPERIMENTAL

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.

Device: CPAP device; Behavioral: CPAP technical support; Behavioral: Phone follow-up for adherence feedback and self-management skills; Behavioral: myAir; Behavioral: Tailored messages; Behavioral: Written Materials; Behavioral: Motivational Enhancement Therapy (MET)

Standard Support

ACTIVE COMPARATOR

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.

Device: CPAP device

Interventions

CPAP device DEVICE

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

Intensive Support; Standard Support

CPAP technical support BEHAVIORAL

Trained personnel will conduct mask selection and fitting, provide continual troubleshooting, and train participants on CPAP.

Intensive 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.

Intensive Support

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.

Intensive Support

Written Materials BEHAVIORAL

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

Intensive Support

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.

Intensive Support

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

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

Intensive Support

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• Use of positive airway pressure within 14 days prior to stroke
• History of pneumothorax, bullous emphysema or other serious co-morbid conditions which limit CPAP use
• Stroke related to tumors, vascular malformations or subarachnoid hemorrhage
• 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
• Anticipated inpatient rehabilitation length of stay \< 5 nights
• Co-morbid conditions that limit OSA testing or CPAP use in the judgement of the study team
• Recent cranial or spinal surgery with known or possible CSF leak or pneumocephalus within past 3 months
• 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.

Sponsors & Collaborators

• University of Washington: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (2)

Rancho Research Institute

Downey, California, 90242, United States

RECRUITING

University of Washington - Harborview Medical Center

Seattle, Washington, 98104, United States

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Sleep Apnea Syndromes

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Sandeep Khot, MD, MPH

  University of Washington

  PRINCIPAL INVESTIGATOR

• Devin Brown, MD, MS

  University of Michigan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Morgan Aurelio, DNP, MPH, ARNP-CNM

CONTACT

206-543-7589; mca1@uw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Neurology

Study Record Dates

• First Submitted: November 21, 2024
• First Posted: December 9, 2024
• Study Start: January 15, 2025
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)