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Stroke and CPAP Outcome Study 3 (SCOUTS3)

Primary Purpose

Ischemic Stroke, Intra Cerebral Hemorrhage, Obstructive Sleep Apnea

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Continuous positive airway pressure (CPAP)
CPAP technical support intervention
Motivational Enhancement Therapy (MET)
Mobile Health intervention
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Stroke focused on measuring behavioral therapy, continuous positive airway pressure, rehabilitation therapy, stroke recovery, self determination

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of WashingtonRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SCOUTS3 Optimization Arm

Arm 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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Stroke Severity
National Institutes of Health Stroke Scale (NIHSS) [range 0-42; higher scores indicate greater neurologic impairment]
Functional Disability
Modified Rankin Score-9 Questions (mRS-9Q) [range 0-5; higher scores indicate lower level of function in neurological disease]

Full Information

First Posted
September 1, 2023
Last Updated
September 24, 2023
Sponsor
University of Washington
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT06029959
Brief Title
Stroke and CPAP Outcome Study 3
Acronym
SCOUTS3
Official Title
Optimizing Adherence to the Treatment of Sleep Apnea Among Patients With Stroke Undergoing Inpatient Rehabilitation
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 18, 2023 (Anticipated)
Primary Completion Date
April 30, 2028 (Anticipated)
Study Completion Date
June 30, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke, Intra Cerebral Hemorrhage, Obstructive Sleep Apnea, Adherence, Treatment, Motivation
Keywords
behavioral therapy, continuous positive airway pressure, rehabilitation therapy, stroke recovery, self determination

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SCOUTS3 Optimization Arm
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
Continuous positive airway pressure (CPAP)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
CPAP technical support intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Motivational Enhancement Therapy (MET)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Mobile Health intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
CPAP Adherence
Description
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
Secondary Outcome Measure Information:
Title
Stroke Severity
Description
National Institutes of Health Stroke Scale (NIHSS) [range 0-42; higher scores indicate greater neurologic impairment]
Time Frame
From in-person assessment at enrollment to the end of inpatient rehabilitation
Title
Functional Disability
Description
Modified Rankin Score-9 Questions (mRS-9Q) [range 0-5; higher scores indicate lower level of function in neurological disease]
Time Frame
From in-person assessment at enrollment to follow-up timepoint of 90 +/- 14 days after enrollment
Other Pre-specified Outcome Measures:
Title
CPAP partner burden
Description
Zarit Burden Interview (ZBI) [range 0-28; higher scores indicate greater caregiver burden]
Time Frame
At follow-up timepoint of 90 +/- 14 days after enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sandeep Khot, MD, MPH
Phone
206-744-3251
Email
skhot@uw.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandeep Khot, MD, MPH
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Devin Brown, MD, MS
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sandeep Khot, MD, MPH
Email
skhot@uw.edu

12. IPD Sharing Statement

Links:
URL
http://reporter.nih.gov/search/b05ZXayvqUCz6wIm20U-rw/project-details/10658404
Description
NIH Reporter

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Stroke and CPAP Outcome Study 3

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