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Completed

NCT Number: NCT06029959

Stroke and CPAP Outcome Study 3

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.

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Key information

Conditions

Ischemic Stroke Adherence, Treatment Apnea Behavior Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebral Hemorrhage Cerebrovascular Disorders Dyssomnias Health Behavior Hemorrhage Intra Cerebral Hemorrhage Intracranial Hemorrhages Motivation Nervous System Diseases Obstructive Sleep Apnea Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders Stroke Treatment Adherence and Compliance Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Washington

Seattle, Washington, 98122, United States

About this study

In an initial single-arm study, participants with stroke will be tested for OSA and treated with auto-titrating CPAP during inpatient stroke rehabilitation and continued for a 3-month treatment period. Multiple behavioral interventions will be used to improve CPAP use, including intensive CPAP technical support, motivational enhancement therapy, and phone and mobile health automated support. The multicomponent behavioral intervention will be optimized to improve CPAP adherence with the engagement and input of stroke survivors.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

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.

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.

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.

Primary outcomes

  1. CPAP Adherence

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

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

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Optimizing Adherence to the Treatment of Sleep Apnea Among Patients With Stroke Undergoing Inpatient Rehabilitation

Acronym: SCOUTS3

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Sep 8, 2023
Registry last updated
Oct 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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