Stroke and CPAP Outcome Study 3

NCT06029959 | Completed Results FDA Device

• 2 other identifiers: STUDY000169071R01HL164394-01A1
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

A problem with breathing during sleep, called obstructive sleep apnea (OSA), likely increases the risk of stroke and is common in people who have had a stroke, present in about 2/3 of stroke survivors. There is also evidence that OSA predicts worse outcome after stroke. The question being addressed in the Stroke and CPAP Outcome Study 3 (SCOUTS3) is how to improve use of continuous positive airway pressure (CPAP) therapy to treat OSA when started during intensive stroke rehabilitation.

Conditions

Ischemic Stroke; Intra Cerebral Hemorrhage; Obstructive Sleep Apnea; Adherence, Treatment; Motivation

Keywords

behavioral therapy; continuous positive airway pressure; rehabilitation therapy; stroke recovery; self determination

Outcome Measures

Primary Outcomes (1)

• CPAP Adherence

  Mean hours of nightly CPAP use during and after inpatient rehabilitation over 3 months

  From CPAP initiation after study enrollment and sleep apnea testing to 90 days from CPAP initiation

Study Arms (1)

SCOUTS3 Optimization Arm

EXPERIMENTAL

In a single-arm study, participants from acute ischemic stroke or intraparenchymal hemorrhage within the past 30 days will be tested for OSA with a single-night portable OSA test during inpatient rehabilitation (IPR). Eligible participants will then be started on continuous positive airway pressure (CPAP) therapy and exposed to a multicomponent CPAP adherence intervention, beginning during IPR and extending for 3 months. Participants' CPAP use will be monitored, and input regarding the intervention will be sought from the participants, CPAP partners, and the research team implementing the intervention. Data from an initial group of study participants will be reviewed in meetings with the study team and a patient advisory board, and adaptations will be devised and then implemented within the next batch of study participants. Through this iterative process that includes input from important stakeholders, the behavioral intervention will be adapted for use among stroke patients.

Device: Continuous positive airway pressure (CPAP); Behavioral: CPAP technical support intervention; Behavioral: Motivational Enhancement Therapy (MET); Behavioral: Mobile Health intervention

Interventions

Continuous positive airway pressure (CPAP) DEVICE

Eligible participants with a diagnosis of OSA will be set up with autotitrating CPAP by the study's sleep technologist. The CPAP device includes an auto-titrator that adjusts the delivered pressure between 5 to 15 cm of water to eliminate obstructive events.

SCOUTS3 Optimization Arm

CPAP technical support intervention BEHAVIORAL

SCOUTS 3 sleep technologists (ST) will make mask type/size or device adjustments, as needed, and provide training to participants and CPAP partners to improve skills involved with mask placement and device maintenance. For participants with non-acceptance of CPAP over the first night, a standardized desensitization program will be implemented. Persistent problems with CPAP use or mask fit, or any high residual respiratory events will be discussed between the sleep technologist and the study's board-certified sleep medicine physician.

SCOUTS3 Optimization Arm

Motivational Enhancement Therapy (MET) BEHAVIORAL

In-person Motivational Enhancement Therapy (MET) sessions by a trained sleep coach will occur within a week of starting CPAP and, with permission, conducted with a CPAP partner, when available. The MET session recordings will be uploaded into the HIPAA compliant Lyssn platform for evaluation, including feedback to the sleep coach. The goal will be 5 total MET sessions, either in-person or by phone, spanning the inpatient and then outpatient settings.

SCOUTS3 Optimization Arm

Mobile Health intervention BEHAVIORAL

Study participants will be assisted in registering for and trained on the ResMed myAir app. Participants will also receive mobile health messages based on Self-Determination Theory.

SCOUTS3 Optimization Arm

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) able to be consented in English or Spanish

You may not qualify if:

• Unable to obtain informed consent from participant or surrogate
• Incarcerated
• Known pregnancy
• Current mechanical ventilation, tracheostomy or supplemental oxygen use \> 4L/min
• Current use of positive airway pressure or use 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)
• Anticipated inpatient rehabilitation length of stay \< 3 nights

Sponsors & Collaborators

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

Study Sites (1)

University of Washington

Seattle, Washington, 98122, United States

Location

Related Links

• NIH Reporter

MeSH Terms

Conditions

Ischemic Stroke; Cerebral Hemorrhage; Sleep Apnea, Obstructive; Treatment Adherence and Compliance

Interventions

Continuous Positive Airway Pressure; Motivational Interviewing

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Intracranial Hemorrhages; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy; Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: Sandeep Khot, MD
• Organization: University of Washington

skhot@uw.edu

206-744-3251

Study Officials

• Sandeep Khot, MD, MPH

  University of Washington

  PRINCIPAL INVESTIGATOR

• Devin Brown, MD, MS

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, School of Medicine

Study Record Dates

• First Submitted: September 1, 2023
• First Posted: September 8, 2023
• Study Start: October 1, 2023
• Primary Completion: September 30, 2024
• Study Completion: January 1, 2025
• Last Updated: October 8, 2025
• Results First Posted: October 8, 2025

Record last verified: 2025-09

Locations

US (1)