Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Orange, California and other locations
Dates
study started
completion around
Principal Investigator
by Masaki Nagamine, MD

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, Obstructive Sleep Apnea

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

  • UC Irvine accepting new patients
    Orange California 92868 United States
  • Orange County Global Medical Center accepting new patients
    Santa Ana California 92705 United States
  • Rancho Los Amigos National Rehabilitation Center accepting new patients
    Downey California 90242 United States
  • Ronald Reagan UCLA Medical Center accepting new patients
    Los Angeles California 90095 United States
  • UCLA Kaiser Fontana accepting new patients
    Ontario California 91761 United States

Lead Scientist at UC Irvine

  • Masaki Nagamine, MD
    Assistant Health Sciences Professor, Neurology, School of Medicine. Authored (or co-authored) 6 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of Michigan
ID
NCT03812653
Study Type
Interventional
Participants
Expecting 3062 study participants
Last Updated