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Sleep for Stroke Management and Recovery Trial
Overall Recruitment Status: Active, currently enrolling
 
Official Title
Sleep for Stroke Management and Recovery Trial
 
Region Sponsors
California - Northern
University of Michigan
 
Acronym NCT No.
Sleep SMART NCT03812653
 
Study Type Phase
INTERVENTIONAL
n/a
 
Purpose
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.
 
Detailed Description
 
 
 
Inclusion Criteria
  • 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
  • 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
 
Keywords and/or Specific Medical Conditions
  • Brain Diseases
  • Respiratory
  • Cardiovascular Diseases
  • Respiratory Tract Diseases
  • Central Nervous System Diseases
  • Signs and Symptoms
  • Cerebrovascular Disorders
  • Sleep Apnea
  • Dyssomnias
  • Sleep Apnea Syndromes
  • Intrinsic
  • Sleep Disorders
  • Ischemic Stroke
  • Sleep Wake Disorders
  • Nervous System Diseases
  • Stroke
  • Neurology/Neurological Disorders
  • Vascular Diseases
  • Obstructive
  • Apnea
  • Respiration Disorders
 
KP Clinical Facility
  • Oakland Medical Center
  • Oakland Medical Center-Alameda
 
Clinical Area
  • Neurology/Neurological Disorders


Principal Investigator:
Sheila Chan
Contact Information:
- CTP Collaborate Team
-CTPCollaborate@kp.org
-All Kaiser Permanente Northern California Medical Centers


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