LAUSR

The ExVent is an optional accessory to the O2Vent Optima mandibular advancement device (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. This is a prospective, open-label, single-arm study conducted at 3 sites. Subjects who have been diagnosed with mild to moderate OSA (i.e., AHI ≥ 5 and ≤ 30) were included. Screening Phase The subjects completed a PSG study to obtain the baseline AHI and confirm a diagnosis of mild to moderate OSA Home Use Phase Subjects used the O2Vent Optima + ExVent for up to 3 months and logged usage hours. Subsequent to the Home Use Phase subjects underwent an in-lab PSG sleep night while using the O2Vent Optima + ExVent. Primary Effectiveness Outcome Measure: Change in AHI between baseline and the AHI measured during the in-lab PSG sleep night using O2Vent Optima + ExVent. Safety Outcome Measure: Adverse events will be summarized descriptively in terms of type and frequency Patients with mild to moderate OSA were treated with Optima MAD and ExVent for 3 months at 3 different sites in North America. Preliminary data analysis demonstrated that treatment with Optima MAD and ExVent reduced AHI from 13.5±6.4/hr to 6.6±4.5/hr (p< 0.05), average 58% reduction in AHI. The lowest oxygen during sleep increased from 84.6±2.7% to 88.6±2.9% (p< 0.05). Overall success rate (>50% reduction in AHI) with treatment was 80%. During the trial patients on treatment with Optima MAD and ExVent demonstrated no excessive adverse events or device malfunction. The clinical trial confirmed successful treatment with combined use of O2Vent Optima MAD and oral Expiratory Positive Airway Pressure accessory - ExVent in patients with mild to moderate OSA. Treatment was well tolerated with no excessive adverse effects.