Sleep for Stroke Management and Recovery Trial
a study on Ischemic Stroke Sleep Apnea Sleep Disorders Stroke CPAP Telehealth
Summary
- Eligibility
- for people ages 18 years and up (full criteria)
- Location
- at Orange, California and other locations
- Dates
- study startedcompletion around
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 (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, Stroke, CPAP, Telemedicine, Home Sleep Apnea Test, Randomized Clinical Trial, Multicenter Trial, Apnea, Sleep Apnea Syndromes, Obstructive Sleep Apnea
Eligibility
For people ages 18 years and up
Current Inclusion Criteria, as of 6/28/2024:
- Ischemic stroke within the prior 7 days.
- NIH Stroke Scale Score ≥1 at the time of enrollment
Previous Inclusion Criteria, prior to 6/28/2024:
- Ischemic stroke or TIA with ABCD ≥4, within prior 14 days.
Exclusion Criteria (for entire time period):
- pre-event inability to perform all of own basic ADLs
- unable to obtain informed consent from subject or legally authorized representative
- incarcerated
- known pregnancy
- current mechanical ventilation (can enroll later if this resolves) or tracheostomy
- current use of positive airway pressure, or use within one month prior to stroke
- anatomical or dermatologic anomaly that makes use of CPAP interface unfeasible
- severe bullous lung disease
- history of prior spontaneous pneumothorax or current pneumothorax
- hypotension requiring current treatment with pressors (can enroll later if this resolves)
- 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
- massive epistaxis or previous history of massive epistaxis
- cranial surgery or head trauma within the past 6 months, with known or possible CSF leak or pneumocephalus
- 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
- current receipt of oxygen supplementation >4 liters per minute
- 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
terminated
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
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
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