Stroke and CPAP Outcome Study 3

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Device: Continuous positive airway pressure (CPAP)
* Behavioral: CPAP technical support intervention
* Behavioral: Motivational Enhancement Therapy (MET)
* Behavioral: Mobile Health intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SCOUTS3 Optimization Arm<br>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. | Device: Continuous positive airway pressure (CPAP)<br>* 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.<br>Behavioral: CPAP technical support intervention<br>* 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.<br>Behavioral: Motivational Enhancement Therapy (MET)<br>* 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.<br>Behavioral: Mobile Health intervention<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CPAP Adherence | Mean hours of nightly CPAP use during and after inpatient rehabilitation over 3 months | From CPAP initiation after study enrollment and sleep apnea testing to 90 days from CPAP initiation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stroke Severity | National Institutes of Health Stroke Scale (NIHSS) [range 0-42; higher scores indicate greater neurologic impairment] | From in-person assessment at enrollment to the end of inpatient rehabilitation | 
| Functional Disability | Modified Rankin Score-9 Questions (mRS-9Q) [range 0-5; higher scores indicate lower level of function in neurological disease] | From in-person assessment at enrollment to follow-up timepoint of 90 +/- 14 days after enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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behavioral therapy, continuous positive airway pressure, rehabilitation therapy, stroke recovery, self determination