Intensive CPAP Support for Stroke Patients with Sleep Apnea

(SCOUTS3 Trial)

Recruiting at 1 trial location

Overseen By Jason Garcia

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Washington

Must not be taking: Sedatives, Benzodiazepines

Disqualifiers: Pregnancy, Mechanical ventilation, Pneumothorax, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 12 weeks

250 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how well an intensive CPAP support program aids stroke patients with sleep apnea, compared to standard care. Participants will be divided into two groups: one receiving regular CPAP support and the other receiving additional assistance with CPAP use, motivation, and mobile health tools. The study aims to determine if the extra support improves the frequency and effectiveness of CPAP device use during and after rehabilitation. Ideal participants are stroke patients who have experienced a stroke within the last 30 days and can provide consent in English or Spanish. As an unphased trial, this study presents a unique opportunity to contribute to innovative research that could enhance stroke recovery and improve quality of life.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are actively using sedative drugs like benzodiazepines or barbiturates, you may need to stop them 48 hours before certain tests.

What prior data suggests that the CPAP device is safe for stroke patients with sleep apnea?

Research has shown that CPAP (Continuous Positive Airway Pressure) is a safe treatment for sleep apnea in both stroke survivors and those without a stroke history. Studies have found that using CPAP can reduce the risk of another stroke and improve survival rates for stroke patients. Simply put, people using CPAP tend to live longer.

Research also indicates that CPAP aids recovery after a stroke. Patients using CPAP demonstrated improvements in brain function, meaning their cognitive abilities improved after starting treatment. Another study confirmed that CPAP effectively treats sleep apnea in stroke patients.

Overall, CPAP is well-tolerated, with most people using it without serious issues. No major risks have been reported, making it a reliable option for those dealing with sleep apnea after a stroke. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores an intensive support method to enhance CPAP therapy for stroke patients with sleep apnea. While standard care includes basic CPAP setup and education, the intensive approach adds a multicomponent behavioral adherence program. This includes Motivational Enhancement Therapy and a Mobile Health intervention, which aim to improve patient adherence and outcomes. By integrating these additional support layers, the trial seeks to determine if these enhancements can lead to better health results and greater CPAP usage among patients.

What evidence suggests that this CPAP support program is effective for stroke patients with sleep apnea?

Research has shown that CPAP (Continuous Positive Airway Pressure) therapy can aid recovery in stroke patients with obstructive sleep apnea (OSA). One study found that CPAP use was linked to better treatment adherence and possibly improved recovery in stroke patients. Another study discovered that CPAP use reduced the risk of death from any cause in individuals who had a stroke or a transient ischemic attack (mini-stroke). In this trial, participants in the Intensive Support group will receive an intensive support program designed to encourage CPAP use by offering additional assistance, such as technical support and motivational therapy. Regular CPAP use might lead to better recovery and health outcomes for stroke patients. Meanwhile, the Standard Support group will receive basic supportive treatments, similar to usual care. ^{1 2 6 7 8}

Who Is on the Research Team?

Sandeep Khot, MD, MPH

Principal Investigator

University of Washington

Devin Brown, MD, MS

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This trial is for stroke patients with obstructive sleep apnea who are currently in inpatient rehabilitation. Participants should be willing to use a CPAP device and engage with various support programs aimed at improving adherence to the therapy.

Inclusion Criteria

I can give consent in English or Spanish.

I've had a stroke or brain bleed shown on a scan in the last 30 days.

Exclusion Criteria

I can give consent in English or Spanish.

Co-morbid conditions that limit OSA testing or CPAP use in the judgement of the study team

Incarcerated

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive CPAP therapy with either intensive support or standard support during inpatient rehabilitation

12 weeks

Ongoing inpatient visits

Follow-up

Participants are monitored for CPAP adherence and stroke recovery outcomes

4 weeks

1 visit (phone)

What Are the Treatments Tested in This Trial?

Interventions

• CPAP device

Trial Overview The SCOUTS 3 study tests an intensive CPAP therapy support program against usual care. It involves motivational talks, written materials, phone follow-ups, technical assistance, tailored messages, and myAir app usage to see if these help increase CPAP use during stroke recovery.

How Is the Trial Designed?

Group I: Intensive Support Experimental Treatment 7 Interventions

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.

Group II: Standard Support Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

In a study involving 44 stroke patients with obstructive sleep apnea (OSA), treatment with continuous positive airway pressure (CPAP) significantly improved stroke-related impairment as measured by the Canadian Neurological scale, indicating enhanced motor recovery during rehabilitation.

While CPAP treatment led to improvements in sleepiness and some aspects of motor function, it did not show benefits for neurocognitive outcomes, suggesting that while CPAP is safe and effective for certain recovery aspects, it may not address cognitive impairments in stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of continuous positive airway pressure on outcomes of rehabilitation in stroke patients with obstructive sleep apnea. Ryan, CM., Bayley, M., Green, R., et al.[2022]

In a study of 29 acute stroke patients, the algorithms in positive airway pressure (PAP) devices showed a strong correlation with traditional polysomnography for detecting sleep apnea, indicating they can effectively identify respiratory events.

The high accuracy of PAP devices (with an area under the curve above 0.90) suggests they can serve as a practical alternative for diagnosing sleep apnea in acute stroke settings, where full polysomnography is not feasible.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnostic Accuracy of Positive Airway Pressure Device for Sleep Apnea Detection in Acute Stroke Patients. Camilo, MR., Machado, LA., Castilho, CM., et al.[2020]

In a randomized controlled trial involving 36 stroke patients, continuous positive airway pressure (CPAP) treatment for four weeks significantly improved cognitive functions, particularly attention and executive functioning, compared to standard rehabilitation alone.

Despite the cognitive benefits observed with CPAP, there were no measurable improvements in neurological status, activities of daily living, or secondary outcomes like sleepiness and mood, indicating that while CPAP helps cognition, it may not enhance overall functional recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Continuous Positive Airway Pressure on Cognitive and Functional Outcome of Stroke Patients with Obstructive Sleep Apnea: A Randomized Controlled Trial. Aaronson, JA., Hofman, WF., van Bennekom, CA., et al.[2022]

In a study of 166 patients with ischemic stroke, those with moderate to severe obstructive sleep apnea (OSA) who did not tolerate CPAP treatment had a significantly higher risk of mortality (hazards ratio of 2.69) compared to those with milder OSA or those who tolerated CPAP.

Long-term CPAP treatment in patients with moderate to severe OSA and ischemic stroke is associated with a reduced risk of mortality, indicating its potential importance in improving survival outcomes for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous positive airway pressure treatment reduces mortality in patients with ischemic stroke and obstructive sleep apnea: a 5-year follow-up study. Martínez-García, MA., Soler-Cataluña, JJ., Ejarque-Martínez, L., et al.[2022]

In a study of 51 ischemic stroke patients, 67% were found to have significant sleep-disordered breathing (SDB), with 49% exhibiting severe SDB (AHI ≥ 20 events/hour), which is notably higher than the prevalence in control subjects.

Despite the high prevalence of SDB, only a small number of patients (4 out of 34) accepted and complied with CPAP treatment, and those receiving CPAP showed no significant improvement in their apnea-hypopnea index over 3 months, indicating challenges in CPAP acceptance and effectiveness in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevalence of sleep-disordered breathing and continuous positive airway pressure compliance: results in chinese patients with first-ever ischemic stroke. Hui, DS., Choy, DK., Wong, LK., et al.[2019]

In a trial involving 50 stroke patients, starting continuous positive airway pressure (CPAP) therapy on the first night after a stroke significantly reduced the apnea-hypopnea index, indicating improved sleep-related breathing disorders.

Patients using CPAP showed a trend towards better recovery as measured by the National Institutes of Health Stroke Scale, especially those with excellent adherence to CPAP, suggesting potential benefits for stroke recovery without increasing nursing workload.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous positive airway pressure ventilation for acute ischemic stroke: a randomized feasibility study. Minnerup, J., Ritter, MA., Wersching, H., et al.[2022]

In a study of 101 patients who had an ischemic stroke, those treated with CPAP for moderate to severe sleep-disordered breathing showed a significant reduction in the risk of stroke recurrence and mortality, with an odds ratio of 0.13.

The study found that effective CPAP treatment was linked to better cardiovascular survival over a 2-year follow-up, highlighting its potential as a crucial intervention for improving outcomes in stroke patients with sleep-disordered breathing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of CPAP Treatment of Sleep Apnea on Clinical Prognosis After Ischemic Stroke: An Observational Study. Haba-Rubio, J., Vujica, J., Franc, Y., et al.[2020]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06722755

NCT06722755 | Stroke and CPAP Outcome Study 3 ... The SCOUTS 3 study aims to test the effectiveness of an intensive CPAP (Continuous Positive Airway Pressure) therapy support program compared to usual care ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4918984/

Effect of Continuous Positive Airway Pressure on Stroke ... Among the 13 subjects who were assigned to active CPAP and completed the study, 12/13 patients (92%) had evidence of sleep apnea on download of data from the ...

3. withpower.com withpower.com/trial/phase-sleep-apnea-obstructive-2025-8fac3

Intensive CPAP Support for Stroke Patients with Sleep Apnea The SCOUTS 3 study aims to test the effectiveness of an intensive CPAP (Continuous Positive Airway Pressure) therapy support program compared to usual care ...

4. ahajournals.org ahajournals.org/doi/10.1161/STROKEAHA.119.024795

Intensive Continuous Positive Airway Pressure Adherence ... Continuous positive airway pressure (CPAP) for the treatment of obstructive sleep apnea may improve stroke recovery, but adherence is poor.

5. sciencedirect.com sciencedirect.com/science/article/pii/S1052305724006475

Stroke recurrence and all-cause mortality in CPAP-treated ... In this registry-based study, we found that CPAP was associated with a reduction in all-cause mortality in post-stroke/TIA patients with sleep-disordered ...

6. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2025.1624631/full

Continuous positive airway pressure in acute ischemic ... This study aimed to assess the impact of CPAP on hospitalization outcomes for AIS-OSA patients using data from the National Inpatient Sample ( ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT00368628

Continuous Positive Airway Pressure for the Treatment of ... Among patients without stroke, continuous positive airway pressure (CPAP) is a safe and effective treatment for sleep apnea. This feasibility pilot study is a ...

8. jcsm.aasm.org jcsm.aasm.org/doi/10.5664/jcsm.10680

Effectiveness and feasibility of continuous positive airway ... This study indicates that CPAP is a feasible treatment for patients with stroke and sleep apnea, and CPAP is beneficial for neurological improvement in these ...