Non-Inferiority Study of the FRESCA Mask Versus Existing CPAP Mask for Treatment of Obstructive Sleep Apnea

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.