Prospective, open-label, randomized crossover assignment, multi-center non-inferiority study conducted in the United States
This study is designed to demonstrate that the FRESCA Airbox Positive Airway Pressure System is non-inferior to the existing FRESCA Positive Airway Pressure System. Subjects meeting the inclusion and exclusion criteria will be randomized to one sleep night with the existing FRESCA device programmed to fixed pressure and one sleep night with the investigational FRESCA device programmed to auto-adjusting pressure and exhale pressure relief.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
52
Positive Airway Pressure System
Clinical Research Group of St. Petersburg
St. Petersburg, Florida, United States
NeuroTrials Research
Atlanta, Georgia, United States
Neurological Center of North GA
Gainesville, Georgia, United States
Bronson Sleep Health
Portage, Michigan, United States
Apnea-Hypopnea Index (AHI)
The mean combined number of apnea and hypopnea events per hour of sleep
Time frame: 1 sleep night
Oxygen Desaturation Index (ODI)
The number of oxygen desaturations ≥ 4% per hour of sleep
Time frame: 1 sleep night
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Clinilabs Drug Development Corp
New York, New York, United States
Bogan Sleep Consultants
Columbia, South Carolina, United States