Stroke and CPAP Outcome Study 3 (SCOUTS3)

University of Washington

Status: Completed

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

Treatments: Device: Continuous positive airway pressure (CPAP); Behavioral: Mobile Health intervention; Behavioral: CPAP technical support intervention; Behavioral: Motivational Enhancement Therapy (MET)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06029959

1R01HL164394-01A1 (U.S. NIH Grant/Contract)

STUDY00016907

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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36 participants in 1 patient group

SCOUTS3 Optimization Arm

Experimental group

Description:

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.

Treatment:

Behavioral: Motivational Enhancement Therapy (MET)

Behavioral: CPAP technical support intervention

Behavioral: Mobile Health intervention

Device: Continuous positive airway pressure (CPAP)