Oventus ExVent Accessory to the O2Vent Optima Device
The ExVent is an optional accessory to the O2Vent Optima MAD and provides oral Expiratory Positive Airway Pressure (EPAP). Oral EPAP with the ExVent is designed to provide upper airway support via similar mechanisms of action of nasal EPAP devices in commercial distribution, e.g., passive dilatation of the airway, which reduces flow limitation. Nasal EPAP devices are in commercial distribution as stand-alone therapies for the treatment of OSA. The oral EPAP provided by the ExVent accessory is designed to augment the OSA therapy provided by the O2Vent Optima.
• Male or female subject aged 22 years or older.
• Subject completed a PSG study within the last 6 months at the investigational site's sleep lab and obtained a baseline AHI confirming a diagnosis of mild to moderate obstructive sleep apnea.
• Subject (self-reports) that he/she is currently a compliant O2Vent Optima user (i.e., using the device for at least 4 hours/night for at least 5 nights/week).
• Subject completed initial fitting optimization of the O2Vent Optima device.
• Investigator has determined that the subject could abstain from use of the oral appliance or other sleep apnea therapies for up to 7 days.
• Must be able to comply with all study requirements as outlined in the protocol.
• Male or female subject aged 22 years or older.
• Subject completed a PSG study within the last 6 months at the investigational site's sleep lab and obtained a baseline AHI confirming a diagnosis of mild to moderate obstructive sleep apnea.
• Subject (self-reports) that he/she is currently a compliant O2Vent Optima user (i.e., using the device for at least 4 hours/night for at least 5 nights/week).
• Subject completed initial fitting optimization of the O2Vent Optima device.
• Investigator has determined that the subject could abstain from use of the oral appliance or other sleep apnea therapies for up to 7 days.
• Must be able to comply with all study requirements as outlined in the protocol.