At a glance
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Randomized Trial of Continuous Positive Airway Pressure in Patients Undergoing Intensive Inpatient Rehabilitation After Acute Stroke
In Brief
A Phase 2 clinical trial evaluating Auto-titrating CPAP and Sham-CPAP for Stroke and Sleep Apnea, Obstructive. Completed, enrolled 40 participants across 1 site.
Detailed Summary
The purpose of this study is to assess the effect of continuous positive airway pressure (CPAP) on functional outcome in patients with acute stroke, the investigators conducted a sham-controlled, double-blind pilot trial during inpatient rehabilitation. Patients with acute stroke were recruited and randomly assigned to auto-titrating or sham-CPAP during their rehabilitation stay.
Study Details
Timeline
Interventions
Auto-titrating CPAP was initiated after admission to the inpatient rehabilitation unit for the duration of rehabilitation but not exceeding 28 days. A respiratory therapist visited patients nightly to document adherence and address issues arising at night. A sleep technologist also met with patients at least twice weekly to monitor safety and adverse events and make any adjustments to the CPAP mask or machine. Efforts to improve adherence to CPAP for patients treated with active-CPAP included patient education, desensitization of CPAP through brief periods of daytime use, adjustments of humidity and mask (including addition of a chin strap), decreasing CPAP maximum pressure and use of expiratory pressure relief (CFlex) for patients treated with active-CPAP.
Sham-CPAP was initiated after admission to the inpatient rehabilitation unit for the duration of rehabilitation but not exceeding 28 days. A respiratory therapist visited patients nightly to document adherence and address issues arising at night. A sleep technologist also met with patients at least twice weekly to monitor safety and adverse events and make any adjustments to the CPAP mask or machine. Efforts to improve adherence to CPAP for patients treated with sham-CPAP included patient education, desensitization of CPAP through brief periods of daytime use and adjustments of humidity and mask, including addition of a chin strap.