StudyFinder
Sleep for Stroke Management and Recovery Trial
RECRUITING
18 years and over
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
• 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
DEVICE: CPAP
Ischemic Stroke, Sleep Apnea, Sleep Apnea, Obstructive, Stroke, CPAP, Telemedicine, Home Sleep Apnea Test, Randomized Clinical Trial, Multicenter Trial
Kayla Novitski, MPH, CCRP - kcgossel@med.umich.edu
NA
NCT03812653