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

Exclusion Criteria

• •1. Subjects with non OSA sleep disorders;
• •2. Substantial central or mixed apneas (Central and Mixed apnea index ≥ 5/hr);
• •3. Subjects actively using bi-level PAP or require oxygen therapy;
• •4. Subjects using a full face mask or chin strap;
• •5. History of severe cardiovascular disease, including New York Heart Association (NYHA) Class III or IV heart failure, coronary artery disease (CAD) with angina or myocardial infarction (MI)/stroke within past 6 months;
• •6. Subjects who are medically complicated or who are medically unstable (i.e. cancer, dementia, unstable cardiac or respiratory disease, or unstable psychiatric illness);
• •7. Potential sleep apnea complications that in the opinion of the investigator may affect the health and safety of the participant including: uncontrolled hypertension or hypotension, low blood oxygen (oxygen desaturations nadirs below 75% on their diagnostic PSG), or use of medication or other treatment which may pose additional risk to the subject;
• •8. Subjects exhibiting any flu-like or any upper airway tract infection symptoms at time of assessment;
• •9. Subjects with ongoing severe nasal allergies or sinusitis or difficulty breathing through the nose; persistent blockage or one or both nostrils; or any nasal or facial abnormalities that would not allow adequate placement of the device;
• •10. Subjects with prior surgical intervention for obstructive sleep hypopnea/ apnea syndrome;
• •11. Currently working nights, rotating night shifts, planned travel across two or more time zones required during study period, or within two weeks prior to study enrollment, or sleep schedule not compatible with sleep lab practices;
• •12. Unstable use of medications or other agents that may affect sleep or PSG (sedatives or hypnotics);
• •13. Pregnant (confirmed verbally);
• •14. Consumption of \> 500mg caffeine per day (e.g. \> 8 cola-type beverages, \> 5 cups of coffee);
• •15. Currently enrolled in any other research study