A Study to Evaluate Sleep for Stroke Management and Recovery

Overview

About this study

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 or high risk TIA (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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • TIA with ABCD2 ≥ 4 or ischemic stroke, within the 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.
  • 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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Eugene Scharf, M.D.

Open for enrollment

Contact information:

Amy Headlee CCRP

(507) 422-0406

Headlee.Amy@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20462965

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