CPAP for Sleep Apnea After Stroke

(Sleep SMART Trial)

Recruiting at 119 trial locations

Overseen By Dawn Meyer, PhD

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether using CPAP, a machine that keeps the airway open during sleep, can benefit individuals who have recently experienced a stroke and also have sleep apnea. Researchers aim to determine if starting CPAP treatment soon after a stroke can reduce the risk of another stroke or heart problems and enhance recovery. Participants will receive either CPAP along with their regular medical care or just their usual care. Individuals who have had an ischemic stroke in the past week and exhibit noticeable stroke symptoms may be suitable for this trial. As an unphased trial, this study provides a unique opportunity to contribute to understanding how CPAP might aid stroke recovery.

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 prior data suggests that CPAP is safe for treating sleep apnea after stroke?

Research has shown that CPAP (Continuous Positive Airway Pressure) is generally safe for people with obstructive sleep apnea (OSA). Studies have found that CPAP use can enhance recovery after a stroke by improving brain function and overall health.

CPAP is a common treatment for sleep apnea and is widely used, indicating that most people tolerate it well. It keeps the airways open during sleep, helping to prevent complications in people with OSA. Importantly, studies have not reported any major safety concerns when CPAP is used after a stroke.

Overall, CPAP is considered a practical and helpful option for stroke patients with sleep apnea, aiding recovery without significant side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using CPAP (Continuous Positive Airway Pressure) for sleep apnea in stroke patients because it offers a unique approach compared to traditional treatments like lifestyle changes or oral appliances. Unlike these methods, CPAP delivers a constant airflow to keep airways open, which may help improve oxygen levels and reduce the risk of further strokes. This technique is particularly promising because it directly addresses the breathing interruptions that can exacerbate stroke recovery, potentially offering better outcomes for patients with sleep apnea after a stroke.

What evidence suggests that CPAP is effective for sleep apnea after stroke?

This trial will compare CPAP (Continuous Positive Airway Pressure) with usual care for patients with sleep apnea after a stroke. Research has shown that CPAP can aid recovery in these patients. Studies have found that CPAP treatment improves brain function and movement. It also lowers the risk of another stroke and reduces mortality rates in stroke patients with sleep apnea. CPAP is considered a beneficial treatment for enhancing patient health. Overall, evidence suggests CPAP effectively aids recovery and prevents further health issues after a stroke. ^{1 2 4 6 7}

Who Is on the Research Team?

Ronald Chervin, MD, MS

Principal Investigator

University of Michigan

Devin Brown, MD, MS

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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 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 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]

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 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]

Citations

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

Effect of Continuous Positive Airway Pressure on Stroke ... Treatment with continuous positive airway pressure (CPAP) among patients diagnosed with OSA is associated with improved functional and motor outcome after ...

2. ahajournals.org ahajournals.org/doi/10.1161/STROKEAHA.120.031709

Trials in Sleep Apnea and Stroke Overall, the data indicate that CPAP might be beneficial for neurological recovery and other nonvascular outcomes, and this justifies the need ...

3. 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 ...

4. 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 ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10476038/

Effectiveness and feasibility of continuous positive airway ... Conclusions: CPAP treatment is feasible in patients with stroke and sleep apnea and may improve neurological outcomes in these patients. However, this finding ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06029959

NCT06029959 | Stroke and CPAP Outcome Study 3 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 ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0012369224006652

Sleep Apnea and Stroke: A Narrative Review Randomized controlled trials have shown that treatment of poststroke OSA using CPAP improves nonvascular outcomes such as cognition and neurologic recovery.