Stroke and CPAP Outcome Study 3

Not Applicable

Recruiting

• Conditions: Ischemic Stroke; Obstructive Sleep Apnea; Motivation; Adherence, Treatment; Intra Cerebral Hemorrhage
• Interventions: Device: Continuous positive airway pressure (CPAP); Behavioral: CPAP technical support intervention; Behavioral: Motivational Enhancement Therapy (MET); Behavioral: Mobile Health intervention

• Registration Number: NCT06029959
• Lead Sponsor: University of Washington

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.

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 Timeline

• Study First Submitted: 2023-09-01
• Study First Submitted QC: 2023-09-01
• Study First Posted: 2023-09-08
• Study Start: 2023-09-28
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-27
• Last Update Posted: 2023-11-29
• Primary Completion: 2024-06-30
• Study Completion: 2028-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SCOUTS3 Optimization Arm	CPAP technical support intervention	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.
SCOUTS3 Optimization Arm	Continuous positive airway pressure (CPAP)	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.
SCOUTS3 Optimization Arm	Motivational Enhancement Therapy (MET)	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.
SCOUTS3 Optimization Arm	Mobile Health intervention	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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) \[range 0-5; higher scores indicate lower level of function in neurological disease\]
Stroke Severity	From in-person assessment at enrollment to the end of inpatient rehabilitation	National Institutes of Health Stroke Scale (NIHSS) \[range 0-42; higher scores indicate greater neurologic impairment\]

Trial Locations

Locations (1)

University of Washington; 🇺🇸 Seattle, Washington, United States