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Treatment of sleep apnea to improve recovery after stroke

Sleep for Stroke Management and Recovery Trial

Not applicable Interventional University of Michigan · NCT03812653

This study tests if treating sleep apnea right after a stroke can help prevent more strokes and other serious health issues in people recovering from their first stroke.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment3062 (estimated)
Ages18 Years and up
SexAll
SponsorUniversity of Michigan Academic / other
Locations116 sites (Birmingham, Alabama and 115 other locations)
Trial IDNCT03812653 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate whether treating obstructive sleep apnea (OSA) with positive airway pressure shortly after an ischemic stroke can reduce the risk of recurrent strokes, acute coronary syndrome, and all-cause mortality after six months. It employs a prospective, randomized, open-label, blinded-endpoint design, comparing six months of OSA treatment to usual care. The trial will involve 3,062 participants across 110 sites within the NINDS-funded StrokeNet clinical trials network over a five-year period.

Who should consider this trial

Good fit: Ideal candidates are individuals who have experienced an ischemic stroke within the past seven days and have a NIH Stroke Scale Score of 1 or higher.

Not a fit: Patients who are unable to perform basic activities of daily living prior to the stroke or those with severe comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve recovery outcomes and reduce the risk of further cardiovascular events in stroke patients with sleep apnea.

How similar studies have performed: Other studies have shown promising results in treating sleep apnea in stroke patients, indicating that this approach may be effective.

Eligibility criteria

Show full inclusion / exclusion criteria 
Current Inclusion Criteria, as of 6/28/2024:

1. Ischemic stroke within the prior 7 days.
2. NIH Stroke Scale Score ≥1 at the time of enrollment

Previous Inclusion Criteria, prior to 6/28/2024:

1. Ischemic stroke or TIA with ABCD ≥4, within prior 14 days.

Exclusion Criteria (for entire time period):

1. pre-event inability to perform all of own basic ADLs
2. unable to obtain informed consent from subject or legally authorized representative
3. incarcerated
4. known pregnancy
5. current mechanical ventilation (can enroll later if this resolves) or tracheostomy
6. current use of positive airway pressure, or use within one month prior to stroke
7. anatomical or dermatologic anomaly that makes use of CPAP interface unfeasible
8. severe bullous lung disease
9. history of prior spontaneous pneumothorax or current pneumothorax
10. hypotension requiring current treatment with pressors (can enroll later if this resolves)
11. other specific medical circumstances that conceivably, in the opinion of the site PI, could render the patient at risk of harm from use of CPAP
12. massive epistaxis or previous history of massive epistaxis
13. cranial surgery or head trauma within the past 6 months, with known or possible CSF leak or pneumocephalus
14. 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
15. current receipt of oxygen supplementation \>4 liters per minute
16. current contact, droplet, respiratory/airborne precautions

Where this trial is running

Birmingham, Alabama and 115 other locations

+66 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Ischemic StrokeSleep ApneaSleep Apnea, ObstructiveStrokeCPAPTelemedicineHome Sleep Apnea TestRandomized Clinical Trial
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.