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Active, currently enrolling

Sleep for Stroke Management and Recovery Trial

NCT No.: NCT03812653

Study Type: INTERVENTIONAL

Phase: n/a

Region: California - Northern

Acronym: Sleep SMART

Official Title

Sleep for Stroke Management and Recovery Trial

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

Sex

Male & Female

Age Limit

Eligibility Criteria

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
  • Cardiovascular Diseases
  • Central Nervous System Diseases
  • Cerebrovascular Disorders
  • Dyssomnias
  • Intrinsic
  • Ischemic Stroke
  • Nervous System Diseases
  • Neurology/Neurological Disorders
  • Obstructive
  • Respiration Disorders
  • Respiratory
  • Respiratory Tract Diseases
  • Signs and Symptoms
  • Sleep Apnea
  • Sleep Apnea Syndromes
  • Sleep Disorders
  • Sleep Wake Disorders
  • Stroke
  • Vascular Diseases
  • Apnea

Sponsors

  • University of Michigan

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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