Summary

for people ages 18 years and up (full criteria)
at La Jolla, California and other locations
study started
estimated completion
Dawn Meyer, PhD

Description

Summary

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 or high risk TIA (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.

Details

Sleep SMART has a prospective, randomized, open-label, blinded-endpoint (PROBE) design. It is a multi-site, parallel-group superiority trial that compares 6 months of OSA treatment to usual care. The study includes two trials: a prevention study with an embedded recovery trial. 3062 subjects will be randomized over 5 years at 110 sites within the NINDS-funded StrokeNet clinical trials network.

Keywords

Ischemic Stroke Sleep Apnea Sleep Apnea, Obstructive TIA Stroke CPAP Telemedicine Home Sleep Apnea Test Randomized Clinical Trial Multicenter Trial Apnea Sleep Apnea Syndromes

Eligibility

You can join if…

Open to people ages 18 years and up

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

You CAN'T join if...

  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

Locations

  • UCSD Health La Jolla accepting new patients
    La Jolla California 92103 United States
  • UCSD Medical Center - Hillcrest Hospital not yet accepting patients
    San Diego California 92103 United States

Lead Scientist

  • Dawn Meyer, PhD
    Associate Clinical Professor, Neurosciences. Authored (or co-authored) 20 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of Michigan
ID
NCT03812653
Study Type
Interventional
Last Updated