Stroke and CPAP Outcome Study 3

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

Interventions

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.

Sponsors & Collaborators

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

  collaborator NIH

• University of Washington

  lead OTHER

Principal Investigators

• Sandeep Khot, MD, MPH · University of Washington

• Devin Brown, MD, MS · University of Michigan

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-10-01

Primary Completion

2024-09-30

Completion

2025-01-01

FDA Device

Yes

Countries

• United States

Study Locations