SCOUTS3: Stroke and CPAP Outcome Study 3

Sponsor

University of Washington (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06029959

Collaborator

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

Enrollment

Location

Arm

57.4

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Ischemic Stroke Intra Cerebral Hemorrhage Obstructive Sleep Apnea Adherence, Treatment Motivation	Device: Continuous positive airway pressure (CPAP) Behavioral: CPAP technical support intervention Behavioral: Motivational Enhancement Therapy (MET) Behavioral: Mobile Health intervention	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Sep 18, 2023

Anticipated Primary Completion Date :

Apr 30, 2028

Anticipated Study Completion Date :

Jun 30, 2028

Arms and Interventions

Arm	Intervention/Treatment
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.	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.

Arm

Intervention/Treatment

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.

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.

Outcome Measures

Primary Outcome Measures

CPAP Adherence [From CPAP initiation after study enrollment and sleep apnea testing to 90 days from CPAP initiation]
Mean hours of nightly CPAP use during and after inpatient rehabilitation over 3 months

Secondary Outcome Measures

Stroke Severity [From in-person assessment at enrollment to the end of inpatient rehabilitation]
National Institutes of Health Stroke Scale (NIHSS)
Functional Disability [From in-person assessment at enrollment to follow-up timepoint of 90 +/- 14 days after enrollment]
Modified Rankin Score-9 Questions (mRS-9Q)

Other Outcome Measures

CPAP partner burden [At follow-up timepoint of 90 +/- 14 days after enrollment]
Zarit Burden Interview

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age 18 years or older
Admitted to inpatient rehabilitation unit at University of Washington (UW)
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