Stroke and CPAP Outcome Study 3

Part of paid clinical trials in Seattle, Washington.

Sponsor
University of Washington
Study ID
NCT06029959
Status
Completed

Conditions

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

Eligibility Criteria

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

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.
  • 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.

Study Details

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.

Key Dates

Start date
Oct 1, 2023
Status verified
Sep 2025
Primary completion
Sep 30, 2024
Completion
Jan 1, 2025

Study Design

Enrollment
36 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: SCOUTS3 Optimization Arm
    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.

Primary Outcome Measure

CPAP Adherence [ Time Frame: From CPAP initiation after study enrollment and sleep apnea testing to 90 days from CPAP initiation ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of WashingtonSeattleWashington98122-

Find similar trials in Seattle, WA

By condition
Stroke
By specialty
NeurologyBrain disorders
By research site
University of Washington· Seattle, WA

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