CPAP for Sleep Apnea After Stroke

(Sleep SMART Trial)

Recruiting at 135 trial locations

Overseen By Shraddha Mainali, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

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: Unknown

Duration: 6 months

3062 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to determine whether treatment of obstructive sleep apnea (OSA) with positive airway pressure starting shortly after acute ischemic stroke (1) reduces recurrent stroke, acute coronary syndrome, and all-cause mortality 6 months after the event, and (2) improves stroke outcomes at 3 months in patients who experienced an ischemic stroke.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.

What data supports the effectiveness of the treatment CPAP for sleep apnea after stroke?

Research shows that using CPAP (a machine that helps keep your airway open while you sleep) can improve recovery in stroke patients who have sleep apnea, a condition where breathing stops and starts during sleep. Studies suggest that treating sleep apnea with CPAP can lead to better motor, functional, and cognitive recovery after a stroke. ^{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. However, it may be poorly tolerated by some stroke patients, meaning they might find it uncomfortable or difficult to use. ^{1 2 6 7 8}

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

CPAP (Continuous Positive Airway Pressure) is unique because it provides a steady stream of air through a mask to keep airways open, which is particularly important for stroke patients who often experience sleep apnea. Unlike other treatments, CPAP is initiated immediately after a stroke to potentially improve recovery and long-term outcomes, although it may not be well-tolerated by all patients. ^{1 7 9 10 11}

Research Team

Ronald Chervin, MD, MS

Principal Investigator

University of Michigan

Devin Brown, MD, MS

Principal Investigator

University of Michigan

Eligibility Criteria

This trial is for individuals who've had a TIA with an ABCD2 score of at least 4 or an ischemic stroke within the last two weeks. It's not suitable for those with certain physical anomalies, severe lung disease, recent major skull surgery, high oxygen needs, current infections requiring isolation, pregnant women, mechanical ventilation users (unless resolved), prior CPAP use within a month before the stroke, history of spontaneous pneumothorax or massive epistaxis.

Inclusion Criteria

TIA with ABCD2 ≥4 or ischemic stroke, within the prior 14 days

Exclusion Criteria

You have a physical abnormality or skin condition that makes it impossible to use the CPAP device.

You have a serious lung condition called bullous lung disease.

recent hemicraniectomy or suboccipital craniectomy (i.e. those whose bone has not yet been replaced), or any other recent bone removal procedure for relief of intracranial pressure

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive CPAP treatment or usual care for obstructive sleep apnea for 6 months

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of stroke outcomes and quality of life

3 months

Treatment Details

Interventions

• CPAP

Trial Overview The study tests if using CPAP to treat obstructive sleep apnea soon after an ischemic stroke can reduce further strokes or heart issues and death from any cause six months later. It also checks if it helps improve recovery three months post-stroke. Participants are randomly chosen to receive either CPAP treatment or no such intervention in multiple centers.

Participant Groups

Group I: Intervention Arm: CPAP with Usual Care. Experimental Treatment 1 Intervention

6 months of CPAP plus usual medical therapy.

Group II: Control Arm: Usual Care. Active Control 1 Intervention

6 months of usual medical therapy alone.

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

University of Cincinnati

Collaborator

Trials

442

Recruited

639,000+

FusionHealth LLC

Collaborator

Trials

1

Recruited

3,100+

Medical University of South Carolina

Collaborator

Trials

994

Recruited

7,408,000+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials

1,403

Recruited

655,000+

Findings from Research

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 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]

Continuous positive airway pressure (CPAP) treatment is feasible for stroke patients with sleep apnea, with an average usage of 4.47 hours per night reported in the studies analyzed.

CPAP may improve neurological function in these patients, but the results should be viewed cautiously due to significant variability across the studies, as indicated by the heterogeneity in the data.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness and feasibility of continuous positive airway pressure in patients with stroke and sleep apnea: a meta-analysis of randomized trials. Fu, S., Peng, X., Li, Y., et al.[2023]

Approximately two-thirds of stroke patients develop obstructive sleep apnea (OSA), which is associated with poorer recovery outcomes compared to those without OSA.

Identifying and treating OSA with positive airway pressure after a stroke is crucial for improving patient morbidity, cognitive recovery, and long-term survival rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A sleeping beast: Obstructive sleep apnea and stroke. McKee, Z., Auckley, DH.[2019]

In a study of 995 stroke patients, the respiratory event index from sleep apnea tests was found to have the strongest correlation with functional recovery after stroke, indicating its potential as a key measure for treatment targeting.

The oxygen desaturation index was linked to a higher risk of recurrent ischemic strokes, suggesting that monitoring this measure could help identify patients at greater risk and guide preventive strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Do apneas and hypopneas best reflect risk for poor outcomes after stroke? Brown, DL., Shafie-Khorassani, F., Kim, S., et al.[2021]

In a study of 238 patients with ischemic stroke and obstructive sleep-disordered breathing, starting CPAP treatment three months post-stroke did not show a significant benefit in preventing new cardiovascular or cerebrovascular events over two years.

The study involved non-sleepy patients, and the low event rate and small sample size may have contributed to the lack of observed benefits, suggesting that earlier intervention or including sleepy patients might be necessary for clearer results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

SAS CARE 2 - a randomized study of CPAP in patients with obstructive sleep disordered breathing following ischemic stroke or transient ischemic attack. Bernasconi, C., Ott, SR., Fanfulla, F., et al.[2022]

In a study involving 19 acute ischemic stroke patients, nasal expiratory positive airway pressure (EPAP) did not significantly reduce the apnea-hypopnea index (AHI), indicating it may not be an effective alternative to continuous positive airway pressure (CPAP) for treating obstructive sleep apnea (OSA) after stroke.

The results showed a nonsignificant reduction in AHI of -5.73 events/h, suggesting that further research is needed to find more effective treatments for OSA in stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Expiratory Positive Airway Pressure for Sleep Apnea after Stroke: A Randomized, Crossover Trial. Wheeler, NC., Wing, JJ., O'Brien, LM., et al.[2021]

In a study of 30 patients with acute ischemic stroke, 73% were found to have sleep apnea, with a median apnea-hypopnea index (AHI) of 23, indicating significant severity of sleep apnea in this population.

The majority of patients (100% median sleep time) slept in the supine position, especially those with more severe strokes, suggesting that positional therapy could be a beneficial intervention for managing sleep apnea in stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High prevalence of supine sleep in ischemic stroke patients. Brown, DL., Lisabeth, LD., Zupancic, MJ., et al.[2021]

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 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]

Over half of stroke survivors experience sleep apnoea in the acute phase, with moderate to severe cases persisting in up to a third of patients during the chronic phase, highlighting the need for better diagnosis and treatment.

Treating sleep apnoea during the acute phase of stroke may improve recovery and long-term outcomes, but challenges in detection and a lack of clear treatment guidelines hinder effective management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep apnoea and ischaemic stroke: current knowledge and future directions. Baillieul, S., Dekkers, M., Brill, AK., et al.[2022]

References

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

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

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

Effectiveness and feasibility of continuous positive airway pressure in patients with stroke and sleep apnea: a meta-analysis of randomized trials. [2023]

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

A sleeping beast: Obstructive sleep apnea and stroke. [2019]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Do apneas and hypopneas best reflect risk for poor outcomes after stroke? [2021]

6. Netherlands pubmed.ncbi.nlm.nih.gov

SAS CARE 2 - a randomized study of CPAP in patients with obstructive sleep disordered breathing following ischemic stroke or transient ischemic attack. [2022]

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

Expiratory Positive Airway Pressure for Sleep Apnea after Stroke: A Randomized, Crossover Trial. [2021]

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

High prevalence of supine sleep in ischemic stroke patients. [2021]

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

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

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

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

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

Sleep apnoea and ischaemic stroke: current knowledge and future directions. [2022]