for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
completion around
Principal Investigator
by Wade Smith, MD, PhD
Headshot of Wade Smith
Wade Smith



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.


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.


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


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


    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


  • UCSF Helen Diller Medical Center at Parnassus Heights accepting new patients
    San Francisco California 94143 United States
  • Kaiser Permanente Los Angeles accepting new patients
    Los Angeles California 94612 United States
  • John Muir Medical Center- Walnut Creek Campus accepting new patients
    Walnut Creek California 94598 United States

Lead Scientist at UCSF

  • Wade Smith, MD, PhD
    Dr. Smith is a neurologist with training in Neurocritical Care and Vascular Neurology. He cares for patients with acute stroke and subarachnoid hemorrhage among all neurovascular conditions. His research interests are in developing methods to rapidly triage stroke patients to appropriate immediate care using biometrics, endovascular stroke therapy and cerebral concussion.


accepting new patients
Start Date
Completion Date
University of Michigan
Study Type
Expecting 3062 study participants
Last Updated