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

Trial Summary

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 data supports the effectiveness of the CPAP treatment for stroke patients with sleep apnea?

Research shows that using CPAP (a machine that helps keep your airway open while you sleep) can improve recovery in stroke patients with sleep apnea, helping them regain motor skills and cognitive functions. It also suggests that CPAP treatment can reduce the risk of death in these patients over time. ^{1 2 3 4 5}

Is CPAP safe for humans?

CPAP (continuous positive airway pressure) is generally considered safe for humans and is commonly used to treat sleep apnea, including in patients who have had a stroke. Studies have shown that it can be used effectively without major safety concerns. ^{1 2 3 4 6}

How does CPAP treatment differ from other treatments for sleep apnea in stroke patients?

CPAP (continuous positive airway pressure) treatment is unique because it provides a steady stream of air through a mask to keep the airways open during sleep, which is particularly beneficial for stroke patients with sleep apnea. Unlike other treatments, CPAP can be initiated immediately after a stroke and may improve recovery by enhancing motor and cognitive functions. ^{1 2 3 6 7}

What is the purpose of this trial?

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.

Research Team

Sandeep Khot, MD, MPH

Principal Investigator

University of Washington

Devin Brown, MD, MS

Principal Investigator

University of Michigan

Eligibility Criteria

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.

I haven't taken sedatives like benzodiazepines or barbiturates in the last 48 hours.

I expect to stay in rehab for less than 5 nights.

Timeline

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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 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 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 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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Effect of CPAP Treatment of Sleep Apnea on Clinical Prognosis After Ischemic Stroke: An Observational Study. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Influence of continuous positive airway pressure on outcomes of rehabilitation in stroke patients with obstructive sleep apnea. [2022]

3. United States 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. [2019]

4. United States 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. [2022]

5. United States 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. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Diagnostic Accuracy of Positive Airway Pressure Device for Sleep Apnea Detection in Acute Stroke Patients. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Continuous positive airway pressure ventilation for acute ischemic stroke: a randomized feasibility study. [2022]