Sleep for Stroke Management And Recovery Trial (Sleep SMART)

Neurology
Masaki Nagamine
Sleep for Stroke Management And Recovery Trial (Sleep SMART)
Brain - Neurologic/ Psychologic
Stroke

Study Description

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.

Experimental: Intervention Arm: CPAP with Usual Care (6 months of CPAP plus usual medical therapy).

vs.

No Intervention: Control Arm: Usual Care (6 months of usual medical therapy alone).

Eligibility

  1. TIA with ABCD2 greater than or equal to 4 or ischemic stroke, within the prior 14 days.
  1. Pre-event inability to perform all of own basic ADLs.
  2. Unable to obtain informed consent from subject or legally authorized representative

incarcerated.

  1. Known pregnancy.
  2. 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.

  1. History of prior spontaneous pneumothorax or current pneumothorax.
  2. 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.

  1. Massive epistaxis or previous history of massive epistaxis.
  2. Cranial surgery or head trauma within the past 6 months, with known or possible CSF leak or pneumocephalus.
  3. 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.
  4. Current receipt of oxygen supplementation >4 liters per minute
  5. Current contact, droplet, respiratory/airborne precautions
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