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

Abstract

Abstract 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.