Abstract Rationale O2Vent Optima, a next generation oral appliance launched in Australia in 2019, has seen successful worldwide adoption for treatment of obstructive sleep apnea. The novel oral appliance incorporates both mandibular advancement to reduce pharyngeal collapsibility and an air channel that allows airflow through the device to circumvent nasopharyngeal obstruction. The ExVent accessory to the novel mandibular advancement device (MAD) provides oral Expiratory Positive Airway Pressure (EPAP) designed to provide upper airway support via similar mechanisms of action as of nasal EPAP devices in commercial distribution, e.g., passive dilatation of the airway, which reduces flow limitation. Most of the published oral appliance efficacy studies have relatively smaller number of participants. Therefore, studies with larger population of patients are required. The purpose of our study was to assess efficacy of the novel combination therapy in a large cohort of patients treated for OSA. Change in polysomnographic variables compared to baseline was assessed as primary outcome measure. Methods Analysis of prospectively collected data for all patients who received O2Vent Optima MAD and ExVent since 2019 was performed. Data collected included: demographics, Total AHI, REM AHI, non-REM, mean SpO2, lowest SpO2, and arousal index were analyzed. Results The O2Vent repository had complete data set including in-laboratory polysomnographic studies at baseline and on therapy for 2,874 patients. Average age was 52.21±13.45, average was BMI 30.19±4.28 and 68% were male. With novel oral appliance, improvement in the following variables were observed. Total AHI from 28.62±7.82 to 11.32±3.21 (p 0.001); REM AHI 35.21±13.82 to 13.27±5.87(p 0.001); non-REM AHI from 18.22±8.43(p 0.001); mean SpO2 from 90.21±1.27% to 94.73±1.27%(p 0.001); nadir SpO2 from 81±2.63% to 90.54% (p 0.001); and arousal index from 22.79±6.85 to 9.43±3.45 (p 0.001). Conclusions In this large cohort of OSA patients, the novel oral appliance and oral EPAP accessory demonstrated a remarkable improvement in sleep apnea polysomnographic variables. The study establishes efficacy of incorporating mandibular advancement with device air channel to circumvent nasopharyngeal obstruction with concurrent use of EPAP accessory. This abstract is funded by: Centre for Sleep and Chronobiology
Sharma et al. (Fri,) studied this question.