To evaluate the safety and effectiveness of the Automatic Expiratory Positive Airway Pressure (Auto-EPAP) feature versus manual expiratory positive airway pressure (EPAP) in the Vivo 45 LS Ventilator.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
23
Provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation
Insomnia and Sleep Institute of Arizona, LLC
Scottsdale, Arizona, United States
University of California San Diego
San Diego, California, United States
Delta Waves
Colorado Springs, Colorado, United States
Bogan Sleep Consultants
Columbia, South Carolina, United States
Exploratory effectiveness endpoint is to evaluate the subject's mean Oxygen Desaturation Index (ODI4%) during each overnight polysomnography assessment.
The log of the subject's mean Oxygen Desaturation Index (ODI4%) measured during each overnight polysomnography assessment (i.e., log10 (mean+1)).
Time frame: Up to Five Weeks
Exploratory effectiveness endpoint is to evaluate the log of the subject's mean Apnea Hypopnea Index (AHI) during each overnight polysomnography assessment.
The log of the subject's mean Apnea Hypopnea Index (AHI) measured during each overnight polysomnography assessment (i.e., log10 (mean+1)).
Time frame: Up to Five Weeks
The primary safety endpoint is the occurrence of device-related serious adverse events (SADEs).
Time frame: Up to Five Weeks
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