Stroke and CPAP Outcome Study 3

University of Washington36 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Ischemic Stroke Intra Cerebral Hemorrhage Obstructive Sleep Apnea

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 interventionBEHAVIORAL

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 interventionBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

CPAP Adherence

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

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