Ischemic StrokeSCOUTS3NCT06029959
Stroke and CPAP Outcome Study 3
A study testing Continuous positive airway pressure (CPAP), CPAP technical support intervention and Motivational Enhancement Therapy (MET) in people with Ischemic Stroke and Intra Cerebral Hemorrhage, run by University of Washington at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke, Intra Cerebral Hemorrhage, Obstructive Sleep Apnea
- What is being tested?
- Continuous positive airway pressure (CPAP), CPAP technical support intervention and Motivational Enhancement Therapy (MET)
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2023to 1 Jan 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Optimizing Adherence to the Treatment of Sleep Apnea Among Patients With Stroke Undergoing Inpatient Rehabilitation
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.
Read the 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.
- Conditions
- Ischemic Stroke, Intra Cerebral Hemorrhage, Obstructive Sleep Apnea, Adherence, Treatment, Motivation
- Being tested
- Continuous positive airway pressure (CPAP), CPAP technical support intervention, Motivational Enhancement Therapy (MET), Mobile Health intervention
- Keywords
- behavioral therapy, continuous positive airway pressure, rehabilitation therapy, stroke recovery, self determination
- Medical subject headings
- Ischemic Stroke, Cerebral Hemorrhage, Sleep Apnea, Obstructive, Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous positive airway pressure (CPAP)Device
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.
CPAP technical support interventionBehavioural
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.
Motivational Enhancement Therapy (MET)Behavioural
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.
Mobile Health interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| SCOUTS3 Optimization Arm | Experimental | 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. Receives: Device: Continuous positive airway pressure (CPAP); Behavioral: CPAP technical support intervention; Behavioral: Motivational Enhancement Therapy (MET); Behavioral: Mobile Health intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
CPAP Adherence
Mean hours of nightly CPAP use during and after inpatient rehabilitation over 3 months
Measured: From CPAP initiation after study enrollment and sleep apnea testing to 90 days from CPAP initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2023
- Study start1 Oct 2023
- Primary completion30 Sep 2024
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Sandeep Khot, University of Washington
- Investigators
- Sandeep Khot, MD, MPH, Principal investigator, University of WashingtonDevin Brown, MD, MS, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06029959
- Sponsor's protocol ID
- STUDY00016907
- Other IDs
- 1R01HL164394-01A1
- Acronym
- SCOUTS3
- Status last verified
- Sep 2025
- First submitted
- 1 Sep 2023
- Last updated
- 8 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Adherence to the Treatment of Sleep Apnea Among Patients With Stroke Undergoing Inpatient Rehabilitation
- ClinicalTrials.gov ID
- NCT06029959
- Acronym / sponsor ID
- SCOUTS3 / STUDY00016907
- Conditions
- Ischemic Stroke, Intra Cerebral Hemorrhage, Obstructive Sleep Apnea, Adherence, Treatment, Motivation
- Keywords
- behavioral therapy, continuous positive airway pressure, rehabilitation therapy, stroke recovery, self determination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 8 Sep 2023 (actual)
- Results
- Posted 8 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SCOUTS3 Optimization Arm | Experimental | Device: Continuous positive airway pressure (CPAP), Behavioral: CPAP technical support intervention, Behavioral: Motivational Enhancement Therapy (MET), Behavioral: Mobile Health interventionIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | SCOUTS3 Optimization Arm |
| CPAP technical support interventionSCOUTS 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. | Behavioural | SCOUTS3 Optimization Arm |
| 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. | Behavioural | SCOUTS3 Optimization Arm |
| Mobile Health interventionStudy 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. | Behavioural | SCOUTS3 Optimization Arm |
Primary outcome
CPAP Adherence
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- NIH ReporterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandeep Khot, MD, MPH principal investigator
University of Washington
Devin Brown, MD, MS principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous positive airway pressure (CPAP), CPAP technical support intervention and Motivational Enhancement Therapy (MET) in people with Ischemic Stroke and Intra Cerebral Hemorrhage, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CPAP Adherence (time frame: From CPAP initiation after study enrollment and sleep apnea testing to 90 days from CPAP initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2025.