Efficacy of the ExVent Accessory for the O2Vent Optima Oral Appliance in the Treatment of Obstructive Sleep Apnea

Abstract

Study Objectives: An optional accessory for the O2Vent Optima mandibular advancement device, the ExVent, provides oral expiratory positive airway pressure (EPAP). Similar to nasal EPAP, oral EPAP results in passive airway dilatation, reducing flow limitation. The present study was conducted to evaluate the safety and efficacy of the ExVent accessory for the treatment of mild to moderate obstructive sleep apnea (OSA). Methods: This prospective, multicenter, open-label, single-arm study enrolled participants diagnosed with mild to moderate OSA (defined as apnea–hypopnea index [AHI] 5–29). During the Home Use Phase, study participants logged their hours of O2Vent Optima + ExVent usage at home over 3 months. Participants were then evaluated by in-laboratory polysomnogram while using the O2Vent Optima + ExVent. The primary effectiveness measure was a change in AHI relative to baseline while using the O2Vent Optima + ExVent. Results: Treatment with the O2Vent Optima + ExVent improved AHI by 62% on average, from 15.3 (interquartile range [IQR]: 11.5–19.5) to 5.8 (IQR: 3.9–6.8; p<0.001). Mean oxygen saturation improved from 93.5%±1.2% to 94.6%±1.34% (p=0.006). The lowest oxygen saturation increased from 85% (IQR: 83%–87%) to 90% (IQR: 89%–95; p<0.001). The overall treatment success rate (AHI<5) was 66%, and the treatment response rate (>50% reduction in AHI) was 77%. No excessive adverse events or device malfunction events were reported. Conclusions: Use of the O2Vent Optima with the ExVent oral EPAP accessory successfully reduced AHI in mild to moderate OSA with no significant adverse effects.