Non-Inferiority Study of the FRESCA Airbox Positive Airway Pressure System

Exclusion Criteria

• •1. Subjects with non-OSA sleep disorders (including periodic limb movement (PLM) disorder and chronic insomnia).
• •2. Subjects with substantial central or mixed apneas (central and mixed apnea ≥ 5/hr.).
• •3. Subjects with prior surgical intervention for OSA.
• •4. Subjects with frequent or sustained episodes of O2 saturation ≤75%.
• •5. Subjects with obesity-related hypoventilation.
• •6. Subjects currently using a CPAP full face mask.
• •7. Subjects who are medically unstable.
• •8. Subjects with unstable or severe cardiovascular abnormalities (e.g., heart failure, valvular heart disease).
• •9. Subjects with atrial fibrillation or other arrhythmias that are not effectively controlled with medication.
• •10. Subjects with hypotension or uncontrolled HTN.
• •11. Subjects with chronic lung disease, including COPD.
• •12. Subjects with significant cardiopulmonary disease.
• •13. Subjects with ongoing severe nasal allergies or sinusitis or difficulty breathing through the nose; persistent blockage of one or both nostrils; or any nasal or facial abnormalities that would not allow adequate placement and use of the mask.
• •14. Subjects with surgery of the upper airway, nose, sinus or middle ear within the previous year.
• •15. Subjects currently working nights, rotating night shifts or with planned travel during the study period.
• •16. Subjects on a non-stable dose of medications or other agents that may affect sleep and/or PSG (e.g., sedatives or hypnotics).
• •17. Subjects who consume \> 500 mg caffeine per day (e.g., \> 8 cola-type beverages, \> 5 cups of coffee).
• •18. Subjects who consume \> 14 alcoholic drinks/week.
• •19. Subjects who are pregnant (confirmed verbally).
• •20. Subjects currently enrolled in any other research study.