Sleep for Stroke Management and Recovery Trial
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Scottsdale/Phoenix, Arizona: 20-011568
NCT ID: NCT03812653
About this study
The primary objectives of this study are to determine whether treatment of OSA with positive airway pressure starting shortly after acute ischemic stroke or high risk TIA reduces recurrent stroke, acute coronary syndrome, and all-cause mortality 6 months after the event, and 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:
- Age ≥ 18 years old.
- TIA with ABCD2 ≥ 4 or ischemic stroke within the prior 14 days.
Exclusion Criteria:
- Individuals < 18 years old.
- 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, or respiratory/airborne precautions.
Eligibility last updated 8/30/21. Questions regarding updates should be directed to the study team contact.
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 |
|
Scottsdale/Phoenix, Ariz.
Mayo Clinic principal investigator Oana Dumitrascu, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available