NCT06029959

Stroke and CPAP Outcome Study 3

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

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

Interventions

Type	Name	Description
DEVICE	Continuous positive airway pressure (CPAP)	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.
BEHAVIORAL	CPAP technical support intervention	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.
BEHAVIORAL	Motivational Enhancement Therapy (MET)	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.
BEHAVIORAL	Mobile Health intervention	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.

Timeline

• Start date: 2023-10-01
• Primary completion: 2024-09-30
• Completion: 2025-01-01
• First posted: 2023-09-08
• Last updated: 2025-10-08
• Results posted: 2025-10-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study