CPAP Treatment for Stroke

(SCOUTS3 Trial)

Overseen By Sandeep Khot, MD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Washington

Must not be taking: Sedatives

Disqualifiers: Pregnancy, Mechanical ventilation, Tumors, others

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

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 91

Duration: 3 months

36 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does exclude people actively using sedative drugs that can interfere with testing for sleep apnea.

What data supports the effectiveness of CPAP treatment for stroke?

The research articles provided do not directly address the effectiveness of CPAP treatment for stroke. However, CPAP is known to help with breathing issues, which can be beneficial in managing conditions like sleep apnea. While not directly related to stroke, improving breathing and oxygen levels could potentially support overall recovery and health in stroke patients. ^{1 2 3 4 5}

Is CPAP therapy generally safe for humans?

CPAP therapy is commonly used to treat sleep apnea and is generally considered safe for humans. It may help reduce the risk of heart problems and improve blood pressure, but some people find it uncomfortable to use. ^{6 7 8 9 10}

How is CPAP treatment different from other treatments for stroke?

CPAP treatment is unique for stroke patients as it focuses on managing sleep apnea, which can occur after a stroke, by keeping the airways open during sleep. This approach is different from other stroke treatments that typically focus on restoring blood flow or protecting brain cells. ^{7 10 11 12 13}

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 adults who've had a recent stroke, confirmed by CT or MRI within the last 30 days. They must be able to give consent in English or Spanish. It's not for those with strokes from tumors, certain lung conditions, using sedatives that affect sleep tests, on mechanical breathing support, pregnant women, or anyone unable to use CPAP.

Inclusion Criteria

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

I or my legal representative can give consent in English or Spanish.

Exclusion Criteria

You are currently using a positive airway pressure machine or have used one in the 14 days before having a stroke.

I have a lung condition that makes it hard to use CPAP.

I expect to stay in rehab for less than 3 nights.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Inpatient Rehabilitation

Participants are tested for OSA with a single-night portable OSA test during inpatient rehabilitation and started on CPAP therapy

Duration of inpatient rehabilitation

Inpatient stay

Treatment

Participants receive CPAP therapy and a multicomponent adherence intervention for 3 months

3 months

Multiple visits (in-person and virtual)

Follow-up

Participants are monitored for CPAP adherence and functional outcomes

90 days

Follow-up assessment at 90 +/- 14 days

Treatment Details

Interventions

• Continuous positive airway pressure (CPAP)
• CPAP technical support intervention
• Mobile Health intervention
• Motivational Enhancement Therapy (MET)

Trial Overview SCOUTS3 aims to improve outcomes after stroke by increasing the effectiveness of CPAP therapy during intensive rehabilitation for obstructive sleep apnea (OSA). The study includes motivational enhancement and mobile health interventions alongside technical support for CPAP users.

Participant Groups

Group I: SCOUTS3 Optimization Arm Experimental Treatment 4 Interventions

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.

Continuous positive airway pressure (CPAP) is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as CPAP for:

• Obstructive Sleep Apnea (OSA)

Approved in United States as CPAP for:

• Obstructive Sleep Apnea (OSA)
• Central Sleep Apnea (CSA)

Approved in Canada as CPAP for:

• Obstructive Sleep Apnea (OSA)

Approved in Japan as CPAP for:

• Obstructive Sleep Apnea (OSA)

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 131 patients with brain trauma, those treated with an ICP-oriented protocol (keeping ICP below 20 mm Hg) showed better outcomes if they were pressure-passive (MABP/ICP slope ≥ 0.13), indicating that this approach may be beneficial for certain patients.

Conversely, patients treated with a CPP-oriented protocol (maintaining CPP above 70 mm Hg) had worse outcomes if they experienced even short durations of CPP insults, suggesting that maintaining higher CPP is critical for those who are pressure-active (MABP/ICP slope < 0.13).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pressure reactivity as a guide in the treatment of cerebral perfusion pressure in patients with brain trauma. Howells, T., Elf, K., Jones, PA., et al.[2022]

Stroke is a leading cause of death, primarily caused by thrombotic and embolic arterial blockages, highlighting the need for better identification and management of stroke-prone patients.

Current treatments for acute cerebral ischemia focus on preventing further brain damage in still viable areas, with ongoing research into various therapeutic strategies to improve outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medical management of acute cerebral ischemia in the elderly. Biller, J., Love, BB.[2013]

Effective management of ischemic stroke in the intensive care unit involves critical interventions such as airway control and tailored blood pressure goals based on the type of stroke treatment.

Preventing common complications like aspiration pneumonia and deep venous thrombosis is crucial for improving patient outcomes in the ICU after an ischemic stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurocritical Care Aspects of Ischemic Stroke Management. Qaryouti, D., Greene-Chandos, D.[2022]

Thrombolytic therapy, specifically recombinant tissue plasminogen activator (rt-PA), is currently the only approved treatment for acute ischemic stroke, but its effectiveness is limited by a narrow time window for administration.

While additional neuroprotective medications are not yet approved, there are various management strategies available to improve patient outcomes, including preventing complications and supporting recovery, which should be tailored to individual patient circumstances.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of acute ischemic stroke: selecting the right treatment for the right patient. Adams, HP.[2017]

In a study of 285 patients with acute head injuries, implementing protocol-driven neurocritical care significantly improved outcomes for severely head-injured patients, with favorable outcomes increasing from 40.4% to 59.6%.

While overall outcomes did not show a significant increase for all patients, those with raised intracranial pressure (ICP) and those needing complex interventions also experienced high rates of favorable outcomes, suggesting that specialized care can be beneficial even for patients not undergoing surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Specialist neurocritical care and outcome from head injury. Patel, HC., Menon, DK., Tebbs, S., et al.[2022]

In a study of 54 patients with sleep apnoea/hypopnoea syndrome, the average nightly usage of CPAP therapy was only 4.7 hours, which is less than the recommended duration for effective treatment.

There was no correlation between the severity of sleep apnoea and the amount of CPAP used, and patients who experienced side effects from the therapy tended to use it significantly less, highlighting the importance of monitoring and addressing side effects to improve compliance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Compliance with CPAP therapy in patients with the sleep apnoea/hypopnoea syndrome. Engleman, HM., Martin, SE., Douglas, NJ.[2019]

In a study of 178 patients with sleep apnea after acute ischemic stroke, both nasal continuous positive airway pressure (nCPAP) and high-flow nasal cannula (HFNC) significantly reduced rates of pulmonary infection and endotracheal intubation compared to usual care, improving early prognosis.

HFNC was found to be more comfortable than nCPAP, making it a potentially better alternative for patients who struggle with adherence to CPAP therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of ventilation modalities on the early prognosis of patients with poststroke sleep apnea. Li, Z., Pang, M., Zhang, J., et al.[2023]

In a meta-analysis of 18 studies involving 4146 patients, CPAP therapy did not significantly reduce the risk of cardiovascular events compared to control groups, suggesting its efficacy in this area is unclear.

However, CPAP therapy was associated with significantly lower daytime sleepiness and reduced 24-hour systolic and diastolic blood pressure, indicating potential benefits in improving sleep quality and cardiovascular health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of CPAP therapy on cardiovascular events and mortality in patients with obstructive sleep apnea: a meta-analysis. Guo, J., Sun, Y., Xue, LJ., et al.[2022]

Continuous positive airway pressure (CPAP) therapy is an effective treatment for obstructive sleep apnea, which can lead to reduced sympathetic nervous system activity and lower blood pressure.

CPAP therapy also improves inflammatory and metabolic parameters, contributing to a decreased risk of cardiovascular issues in patients with obstructive sleep apnea.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Beneficial effect of continuous positive airway pressure therapy in obstructive sleep apnea syndrome]. Magyar, MT.[2015]

In a study of 4275 patients with obstructive sleep apnea (OSA), those treated with continuous positive airway pressure (CPAP) showed a lower incidence of stroke (3.41 vs 5.43 per 1000 person-years) compared to those who did not receive CPAP treatment.

While CPAP treatment suggested a protective effect against stroke (hazard ratio of 0.68), the results were not statistically significant, indicating that further research is needed to confirm these findings and assess the quality and duration of CPAP use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous positive pressure therapy usage and incident stroke in patients with obstructive sleep apnea: A nationwide population-based cohort study. Chang, ET., Chen, W., Wang, LY., et al.[2021]

In a pilot study involving 12 acute stroke patients, CPAP was well tolerated, with 84% acceptance and an average usage of 5.2 hours, indicating its potential for managing respiratory issues in this population.

While CPAP showed some benefits in reducing respiratory disturbances and blood pressure variability, caution is advised due to significant decreases in cerebral blood flow velocity at higher CPAP pressures, suggesting potential risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptance, effectiveness and safety of continuous positive airway pressure in acute stroke: a pilot study. Scala, R., Turkington, PM., Wanklyn, P., et al.[2016]

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]

Persistent low blood oxygen levels during sleep can hinder the effectiveness of neurorehabilitation in stroke patients, highlighting the need for integrated clinical approaches.

In cases of sleep apnea, combining continuous positive airway pressure therapy with neuroprotective treatments may enhance recovery and is crucial for preventing further strokes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Cellex in the therapy of patients with complex and central apnea in the early recovery period of ischemic stroke]. Lavrick, SY., Borisov, AS., Shprakh, VV.[2021]

References

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

Pressure reactivity as a guide in the treatment of cerebral perfusion pressure in patients with brain trauma. [2022]

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

Medical management of acute cerebral ischemia in the elderly. [2013]

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

Neurocritical Care Aspects of Ischemic Stroke Management. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Treatment of acute ischemic stroke: selecting the right treatment for the right patient. [2017]

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

Specialist neurocritical care and outcome from head injury. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Compliance with CPAP therapy in patients with the sleep apnoea/hypopnoea syndrome. [2019]

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

Effect of ventilation modalities on the early prognosis of patients with poststroke sleep apnea. [2023]

8. Germany pubmed.ncbi.nlm.nih.gov

Effect of CPAP therapy on cardiovascular events and mortality in patients with obstructive sleep apnea: a meta-analysis. [2022]

9. Hungary pubmed.ncbi.nlm.nih.gov

[Beneficial effect of continuous positive airway pressure therapy in obstructive sleep apnea syndrome]. [2015]

10. England pubmed.ncbi.nlm.nih.gov

Continuous positive pressure therapy usage and incident stroke in patients with obstructive sleep apnea: A nationwide population-based cohort study. [2021]

11. England pubmed.ncbi.nlm.nih.gov

Acceptance, effectiveness and safety of continuous positive airway pressure in acute stroke: a pilot study. [2016]

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

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

13. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Cellex in the therapy of patients with complex and central apnea in the early recovery period of ischemic stroke]. [2021]