Sleep for Stroke Management and Recovery Trial

About

Brief Summary

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.

Primary Purpose

Prevention

Study Type

Interventional

Phase

N/A

Eligibility

Gender

All

Healthy Volunteers

No

Minimum Age

18 Years

Maximum Age

N/A

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 (for entire time period):

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