Obstructive Sleep Apnea Clinical Trial
Official title:
Non-Inferiority Study of the FRESCA Mask Versus Existing CPAP Mask for Treatment of Obstructive Sleep Apnea
This will be a prospective study in subjects with Obstructive Sleep Apnea (OSA) to characterize the clinical performance during a single night of therapy with a FRESCA mask compared with a single night of therapy with their existing nasal Continuous Positive Airway Pressure (CPAP) mask.
Obstructive Sleep Apnea (OSA) is a common chronic disorder and the most common of all sleep
disorders. OSA can occur in any age group, but prevalence increases between middle and older
age. Over the last two decades the prevalence of sleep disordered breathing seems to be
increasing in both men and women, likely due to increasing rates of obesity. Relative
increases reported are between 14% and 55% depending on the subgroup. For men, the current
prevalence estimates of moderate to severe sleep-disordered breathing are 10% for 30 to 49
year-olds and 17% for 50 to 70 year-olds. For women, the corresponding prevalence estimates
are 3% and 9%.
Common consequences of OSA include daytime sleepiness, extreme daytime fatigue, slow reaction
time, moodiness, belligerence and vision problems. OSA is also linked to hypertension,
increased cardiovascular morbidity, type 2 diabetes, neurocognitive dysfunction and possibly
cancer.
The study is a prospective, comparative, open label, randomized crossover assignment,
multi-center pivotal study.
Up to forty-five (45) subjects will be enrolled. It is desirable to have the subject
population distributed across the OSA severity criteria range.
The purpose of this study is to demonstrate that the FRESCA mask is non-inferior to a CPAP
nasal mask in maintaining AHI and ODI during a single night of PSG assessment.
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