P070 Efficacy of the ExVent Accessory with the O2Vent Optima Oral Appliance in the Treatment of Obstructive Sleep Apnea – A Clinical Trial

INTRODUCTION: The study assessed the efficacy of oral appliance device O2Vent Optima and ExVent, an oral Expiratory Positive Airway Pressure (EPAP) accessory in the treatment of OSA. METHODS: A prospective, open-label study conducted at 3 sites in mild to moderate OSA (AHI ≥ 5 and ≤ 30). Screening Phase A diagnostic in-lab PSG study confirmed a diagnosis of mild to moderate OSA. Treatment I Subjects used O2Vent Optima for 6 weeks and underwent a PSG sleep night while using the O2Vent Optima. Treatment II Subjects used O2Vent Optima + ExVent for 6 weeks and underwent a PSG sleep night while using the O2Vent Optima + ExVent Primary Effectiveness Measure: Change in AHI between baseline vs. O2Vent Optima MAD vs. O2Vent Optima + ExVent RESULTS: Treatment with Optima, Optima + ExVent reduced AHI from 22.5±6.4/hr to 12.6±4.5/hr to 5.9±2.7 (p< 0.005 baseline vs. Optima and Optima + ExVent; p<0.05 Optima MAD vs. Optima + ExVent). Average reduction in AHI with Optima was 43% and with Optima + ExVent was 72%. The lowest oxygen during sleep increased from 84.6±2.7% to 88.6±2.9% to 91.6±3.2% (p< 0.005 baseline vs. Optima and Optima + ExVent; p<0.05 Optima vs. Optima + ExVent). During the trial patients on treatment with Optima and Optima + ExVent demonstrated no excessive adverse events or device malfunction. CONCLUSION: Treatment with O2Vent Optima and O2Vent Optima + ExVent significantly improved OSA compared to the baseline. Even greater benefit was observed with addition of ExVent to the Optima in mild to moderate OSA.