Abstract Introduction Oral Appliances (OA) are a primary therapy option for mild to moderate OSA patients and for severe OSA patients who are continuous positive airway pressure (CPAP) intolerant. However, there is a paucity of published data for efficacy of OA in severe OSA. A novel oral appliance, O2Vent Optima incorporates both the mandibular advancement and an air channel that allows airflow through the device to circumvent nasopharyngeal obstruction. The ExVent is an accessory to the mandibular advancement device and provides oral Expiratory Positive Airway Pressure (EPAP). Previous studies have established efficacy of the air channel and EPAP of the combination therapy in the treatment of mild to moderate OSA. Study purpose was to assess the efficacy of the EPAP enhanced novel OA in the treatment of severe OSA patients who were either CPAP intolerant or preferred other therapies. Methods A prospective, open-label study conducted at multiple sites included 36 patients with severe OSA (AHI30/hr.). Average age: 58.45±6.86 years; mean BMI: 34.16±8.2; 74% were men. A diagnostic in-lab PSG study was initially performed to confirm a diagnosis of severe OSA. Patients who were CPAP intolerant or preferred OA were approached for study participation and informed consented was obtained. The enrolled patients were evaluated, custom fitted with the EPAP enhanced novel OA and adjustments were clinically guided, The participants used the combination therapy 80% of the nights for 12-week period; compliance was verified. Primary Efficacy Measure: Change in AHI between baseline vs. EPAP enhanced OA. Secondary Efficacy Measures: Treatment success (% of patients with a ≥50% decrease in AHI from baseline); improvement in lowest oxygenation saturation (SpO2 nadir). Results Treatment with the EPAP enhanced OA reduced AHI from 45.43±11.23/hr. to 13.44±6.34/hr. (p 0.005), average 76% reduction in AHI. The lowest oxygen saturation (SpO2 nadir) during sleep increased from 80.82±6.2% to 89.54±1.25% (p 0.005). Treatment success rate was 84%. Conclusion Oral Appliance therapy offers an alternative treatment solution for patients with severe obstructive sleep apnea who are intolerant or refuse CPAP therapy; however, the data is limited. Our study demonstrated successful treatment of patients with severe obstructive sleep apnea with the novel EPAP enhanced Oral Appliance. Support (if any) None
Sharma et al. (Fri,) studied this question.