Stroke PatientsSCOUTS3NCT06722755
Stroke and CPAP Outcome Study 3 Randomized Controlled Trial
A study testing CPAP device, CPAP technical support and Phone follow-up for adherence feedback and self-management skills in people with Stroke Patients and CPAP, run by University of Washington at 2 sites in United States.
Trial summary
The SCOUTS 3 study aims to test the effectiveness of an intensive CPAP (Continuous Positive Airway Pressure) therapy support program compared to usual care in stroke patients with obstructive sleep apnea (OSA) during inpatient rehabilitation (IPR). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke Patients, CPAP, OSA - Obstructive Sleep Apnea
- What is being tested?
- CPAP device, CPAP technical support and Phone follow-up for adherence feedback and self-management skills
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Jan 2025to May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 (LAR)) able to be consented in English or Spanish.
Who cannot join
- Unable to obtain informed consent from participant or LAR in English or Spanish
- Incarcerated
- Known pregnancy-determined by reviewing clinical data
- Current mechanical ventilation, tracheostomy, or supplemental oxygen use > 4L/min
- Use of positive airway pressure within 14 days prior to stroke
- History of pneumothorax, bullous emphysema or other serious co-morbid conditions which limit CPAP use
Show all 12Show 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) including any benzodiazepine, barbiturate, general anesthesia, or conscious sedation within the prior 48 hours of the planned portable sleep apnea study
- Anticipated inpatient rehabilitation length of stay < 5 nights
- Co-morbid conditions that limit OSA testing or CPAP use in the judgement of the study team
- Recent cranial or spinal surgery with known or possible CSF leak or pneumocephalus within past 3 months
- Patients at significant risk of aspiration that could render the patient at risk of harm from use of CPAP, in the opinion of the site PI.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Rancho Research Institute
Downey, California, 90242
Jason Garcia, 562-385-6939
- Recruiting
University of Washington - Harborview Medical Center
Seattle, Washington, 98104
Belqeis Abatiyow, BS, 2067446067, babatiyo@uw.edu
About this study
Official title: Optimizing Adherence to the Treatment of Sleep Apnea Among Patients With Stroke Undergoing Inpatient Rehabilitation
The SCOUTS 3 study aims to test the effectiveness of an intensive CPAP (Continuous Positive Airway Pressure) therapy support program compared to usual care in stroke patients with obstructive sleep apnea (OSA) during inpatient rehabilitation (IPR).
The study is a multicenter randomized controlled trial (RCT) involving recruitment of about 250 participants across two institutions and randomization of about 200 participants. It compares an intensive support (IS) program for CPAP use with standard support (SS) to evaluate the effectiveness of the IS intervention in increasing CPAP usage during and after stroke rehabilitation. The Intensive Support (IS) group will receive a multicomponent intensive behavioral adherence program, which includes a CPAP technical support intervention, Motivational Enhancement Therapy (MET), and a Mobile Health intervention. Outcomes measured include CPAP adherence as measured by average nightly use in minutes between randomization and 3 months and the modified Rankin Scale (mRS-9Q) to evaluate stroke recovery.
Read the detailed description
Within an investigator-initiated, phase 2 multicenter randomized controlled trial, we will test the effect of the multicomponent behavioral adherence intervention on 3-months of CPAP use among stroke patients with obstructive sleep apnea (OSA) and continuous positive airway pressure (CPAP) therapy initiated during inpatient rehabilitation (IPR). The study will be conducted at 2 IPR centers, University of Washington (UW) in Seattle, WA., and Rancho Los Amigos National Rehabilitation Center (RLANRC) in Los Angeles, CA. Over a ~3-year period, adult patients recovering from acute stroke within the past 30 days will be recruited upon IPR admission to these centers and tested for OSA through a simple, portable cardiorespiratory study with automated software. Eligible participants with OSA will be randomized to CPAP plus: either the adapted adherence intervention or control. All randomized subjects will be treated with auto-titrating CPAP or aCPAP. CPAP use will be measured electronically. Both groups will continue CPAP for a 3-month treatment period. We anticipate enrolling approximately 250 participants over the ~3 years of recruitment to randomize 200 eligible participants. The primary endpoint will be the average nightly minutes of CPAP use over the 90-day period, objectively measured, and the secondary outcome will be the Modified Rankin Scale-9 questions assessed at 3 months by phone.
- Conditions
- Stroke Patients, CPAP, OSA - Obstructive Sleep Apnea
- Being tested
- CPAP device, CPAP technical support, Phone follow-up for adherence feedback and self-management skills, myAir, Tailored messages
- Keywords
- behavioral therapy, continuous positive airway pressure, stroke recovery, self determination, sleep apnea
- Medical subject headings
- Sleep Apnea, Obstructive, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAP deviceDevice
Eligible participants with OSA will be started on automatically-adjusting CPAP.
CPAP technical supportBehavioural
Trained personnel will conduct mask selection and fitting, provide continual troubleshooting, and train participants on CPAP.
Phone follow-up for adherence feedback and self-management skillsBehavioural
The research coordinator will call participants approximately monthly to provide any needed support.
myAirBehavioural
Study personnel will assist participants in registering for and using the myAir (ResMed) self-tracking app. This app also provides a library of how-to videos and provides email updates to participants.
Tailored messagesBehavioural
Tailored text messages will be sent to participants. Two-way texting messaging will also be available between the study team and participants.
Written MaterialsBehavioural
A binder of written educational materials will be provided to participants.
Motivational Enhancement Therapy (MET)Behavioural
A trained sleep coach will conduct up to 5 MET sessions with participants and 2 sessions with a CPAP partner during the study time period.
| Study group | Role | What they receive |
|---|---|---|
| Intensive Support | Experimental | The Intensive Support (IS) group will receive the multicomponent intensive behavioral adherence program, which includes a CPAP technical support intervention, Motivational Enhancement Therapy (MET), and a Mobile Health intervention. Participants assigned to the IS group will also receive the 3 basic supportive treatments, including OSA and CPAP education, respiratory therapy and nursing support during inpatient rehabilitation, and referral to a DME company after inpatient rehabilitation discharge if needed. Receives: Device: CPAP device; Behavioral: CPAP technical support; Behavioral: Phone follow-up for adherence feedback and self-management skills; Behavioral: myAir; Behavioral: Tailored messages; Behavioral: Written Materials; Behavioral: Motivational Enhancement Therapy (MET) |
| Standard Support | Active comparator | Participants assigned to the control group will receive only the 3 basic supportive treatments, including OSA and CPAP education, respiratory therapy and nursing support during inpatient rehabilitation, and referral to a DME company after study completion if needed. CPAP will be set up by the respiratory therapist (or similar personnel) on the inpatient rehabilitation (IPR) unit with standard mask fitting and troubleshooting, if available. Assistance with mask placement will be provided by IPR nurses and respiratory therapy, as needed. The control interventions mimic usual care, which typically entails a setup by respiratory therapy and support for CPAP placement and device maintenance by IPR nurses. Receives: Device: CPAP device |
What is being measured
The primary outcome is the main question the study is designed to answer.
CPAP Adherence
Average nightly minutes of CPAP use over the 90-day period is passively transmitted from a modem in each CPAP device via cellular service and securely accessed via the ResMed program, AirView. Alternatively, data cards can be obtained and downloaded.
Measured: 3 months
Secondary outcomes (1)
Stroke recovery measure
Functional disability (mRS-9Q) will be measured at ~90 days by phone [range 0-5; higher scores indicate lower level of function in neurological disease]
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start15 Jan 2025
- Primary completionApr 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke PatientsStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 250 participants (estimated)
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
- NCT06722755
- Sponsor's protocol ID
- STUDY00021430
- Other IDs
- R01HL164394-01A1
- Acronym
- SCOUTS3
- Status last verified
- Mar 2026
- First submitted
- 21 Nov 2024
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. 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
- NCT06722755
- Acronym / sponsor ID
- SCOUTS3 / STUDY00021430
- Conditions
- Stroke Patients, CPAP, OSA - Obstructive Sleep Apnea
- Keywords
- behavioral therapy, continuous positive airway pressure, stroke recovery, self determination, sleep apnea
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 15 Jan 2025 (actual)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 9 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The SCOUTS 3 study aims to test the effectiveness of an intensive CPAP (Continuous Positive Airway Pressure) therapy support program compared to usual care in stroke patients with obstructive sleep apnea (OSA) during inpatient rehabilitation (IPR).
The study is a multicenter randomized controlled trial (RCT) involving recruitment of about 250 participants across two institutions and randomization of about 200 participants. It compares an intensive support (IS) program for CPAP use with standard support (SS) to evaluate the effectiveness of the IS intervention in increasing CPAP usage during and after stroke rehabilitation. The Intensive Support (IS) group will receive a multicomponent intensive behavioral adherence program, which includes a CPAP technical support intervention, Motivational Enhancement Therapy (MET), and a Mobile Health intervention. Outcomes measured include CPAP adherence as measured by average nightly use in minutes between randomization and 3 months and the modified Rankin Scale (mRS-9Q) to evaluate stroke recovery.
Detailed description
Within an investigator-initiated, phase 2 multicenter randomized controlled trial, we will test the effect of the multicomponent behavioral adherence intervention on 3-months of CPAP use among stroke patients with obstructive sleep apnea (OSA) and continuous positive airway pressure (CPAP) therapy initiated during inpatient rehabilitation (IPR). The study will be conducted at 2 IPR centers, University of Washington (UW) in Seattle, WA., and Rancho Los Amigos National Rehabilitation Center (RLANRC) in Los Angeles, CA. Over a ~3-year period, adult patients recovering from acute stroke within the past 30 days will be recruited upon IPR admission to these centers and tested for OSA through a simple, portable cardiorespiratory study with automated software. Eligible participants with OSA will be randomized to CPAP plus: either the adapted adherence intervention or control. All randomized subjects will be treated with auto-titrating CPAP or aCPAP. CPAP use will be measured electronically. Both groups will continue CPAP for a 3-month treatment period. We anticipate enrolling approximately 250 participants over the ~3 years of recruitment to randomize 200 eligible participants. The primary endpoint will be the average nightly minutes of CPAP use over the 90-day period, objectively measured, and the secondary outcome will be the Modified Rankin Scale-9 questions assessed at 3 months by phone.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive Support | Experimental | Device: CPAP device, Behavioral: CPAP technical support, Behavioral: Phone follow-up for adherence feedback and self-management skills, Behavioral: myAir, Behavioral: Tailored messages, Behavioral: Written Materials, Behavioral: Motivational Enhancement Therapy (MET)The Intensive Support (IS) group will receive the multicomponent intensive behavioral adherence program, which includes a CPAP technical support intervention, Motivational Enhancement Therapy (MET), and a Mobile Health intervention. Participants assigned to the IS group will also receive the 3 basic supportive treatments, including OSA and CPAP education, respiratory therapy and nursing support during inpatient rehabilitation, and referral to a DME company after inpatient rehabilitation discharge if needed. |
| Standard Support | Active comparator | Device: CPAP deviceParticipants assigned to the control group will receive only the 3 basic supportive treatments, including OSA and CPAP education, respiratory therapy and nursing support during inpatient rehabilitation, and referral to a DME company after study completion if needed. CPAP will be set up by the respiratory therapist (or similar personnel) on the inpatient rehabilitation (IPR) unit with standard mask fitting and troubleshooting, if available. Assistance with mask placement will be provided by IPR nurses and respiratory therapy, as needed. The control interventions mimic usual care, which typically entails a setup by respiratory therapy and support for CPAP placement and device maintenance by IPR nurses. |
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 (LAR)) able to be consented in English or Spanish.
Key exclusion criteria (12 listed)
- Unable to obtain informed consent from participant or LAR in English or Spanish
- Incarcerated
- Known pregnancy-determined by reviewing clinical data
- Current mechanical ventilation, tracheostomy, or supplemental oxygen use > 4L/min
- Use of positive airway pressure 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 |
|---|---|---|
| CPAP deviceEligible participants with OSA will be started on automatically-adjusting CPAP. | Device | Intensive Support, Standard Support |
| CPAP technical supportTrained personnel will conduct mask selection and fitting, provide continual troubleshooting, and train participants on CPAP. | Behavioural | Intensive Support |
| Phone follow-up for adherence feedback and self-management skillsThe research coordinator will call participants approximately monthly to provide any needed support. | Behavioural | Intensive Support |
| myAirStudy personnel will assist participants in registering for and using the myAir (ResMed) self-tracking app. This app also provides a library of how-to videos and provides email updates to participants. | Behavioural | Intensive Support |
| Tailored messagesTailored text messages will be sent to participants. Two-way texting messaging will also be available between the study team and participants. | Behavioural | Intensive Support |
| Written MaterialsA binder of written educational materials will be provided to participants. | Behavioural | Intensive Support |
| Motivational Enhancement Therapy (MET)A trained sleep coach will conduct up to 5 MET sessions with participants and 2 sessions with a CPAP partner during the study time period. | Behavioural | Intensive Support |
Primary outcome
CPAP Adherence
Time frame: 3 months
Average nightly minutes of CPAP use over the 90-day period is passively transmitted from a modem in each CPAP device via cellular service and securely accessed via the ResMed program, AirView. Alternatively, data cards can be obtained and downloaded.
1 secondary outcome
Stroke recovery measure
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Sandeep Khot, MD, MPH principal investigator
University of Washington
Devin Brown, MD, MS principal investigator
University of Michigan
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPAP device, CPAP technical support and Phone follow-up for adherence feedback and self-management skills in people with Stroke Patients and CPAP, run by University of Washington at 2 sites 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 12 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: looking for participants now, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Belqeis Abatiyow, BS (2067446067, babatiyo@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CPAP Adherence (time frame: 3 months). 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 13 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.