Research & Innovation

StrokeNet Sleep SMART

Clinical Trials

StrokeNet Sleep SMART

Sleep for Stroke Management and Recovery Trial

Physician & Study Coordinator

Physician

Daniel Ackerman, MD

Daniel Ackerman, MD

Study Coordinator

Susan Hahn
484-526-7825
Susan.Hahn2@sluhn.org

Close

Synopsis

Synopsis: This research is being done to figure out whether treatment for sleep apnea, in people who have had a stroke or TIA, improves recovery from stroke, and helps prevent future stroke, heart problems, and death.

The intervention being tested is called continuous positive airway pressure (CPAP). The U.S. Food and Drug Administration (FDA) has approved CPAP for the treatment of obstructive sleep apnea.

 

Sleep apnea is a disorder in which breathing stops or nearly stops repeatedly while you sleep. This condition affects most (about 75 out of 100) stroke and TIA patients. Sleep apnea occurs when the throat narrows or closes off, repeatedly, during sleep. This causes you to stop breathing, or take breaths that are too small, because air flow is blocked. This can happen many times per hour, while you sleep. Each time, your body’s oxygen levels can decrease, and your brain may wake you up – though too briefly for you to remember it – so that you can breathe again. Even though the effects on the brain and body can be dramatic, people often don’t realize that they have sleep apnea.

 

In stroke and TIA patients especially, sleep apnea often goes unnoticed because the typical symptoms, snoring and daytime sleepiness, may not occur. People with sleep apnea may have worse outcomes after stroke. We think CPAP treatment may improve outcomes after stroke. However, we do not know if CPAP treatment has a good or bad effect on stroke recovery or stroke prevention.

Close

Inclusion Criteria

1. TIA with ABCD2 ≥4 or ischemic stroke, within the prior 14 days.

Close

Exclusion Criteria
  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

Close