0546 A Novel EPAP Device for the Treatment of Mild-to-Moderate Obstructive Sleep Apnea

Abstract

Introduction: PAP therapy has long been first-line treatment for obstructive sleep apnea (OSA). However, long-term compliance continues to range from 30 to 70%, diminishing response to therapy. Options for OSA treatment include oral appliances, surgery and nasal expiratory positive airway pressure (EPAP). The aim of this study was to evaluate the efficacy and safety of the Bongo Rx, a novel nasal EPAP device for treatment of mild-to-moderate OSA. Methods: This was a prospective, non-randomized, open label study. Subjects had a diagnosis of mild-to-moderate OSA (AHI ≥5 and ≤30) determined by a diagnostic PSG within 12 months of screening. Subjects were currently using CPAP successfully or were non-compliant with their prescribed therapy. Full face mask users, mouth breathers and subjects with nasal congestion were excluded. Qualifiers were fitted with the device consisting of a conjoined set of soft nasal EPAP valves inserted in the nares. Subjects were evaluated with PSG while wearing the device, wore the device at home for two weeks and returned for a follow-up PSG. Results: Ten subjects completed the two-week trial. Two additional subjects qualified but subsequently withdrew, for an initial acceptance rate of 83%. The baseline diagnostic PSG apnea-hypopnea index (AHI) was compared to the AHI after two weeks of home use. Three subjects had unusable data at the two-week PSG, so their initial treatment PSG was used for analysis. Results show the mean baseline AHI (15.7 ± 6.4) was reduced to a mean AHI (7.1 ± 4.2) at the treatment PSG with the EPAP device (p=0.0093), a reduction of 45%. There were two mild adverse events possibly related to the device and no serious adverse events during the study. Conclusion: The results show that this EPAP device has considerable promise for the treatment of mild-to-moderate OSA. The device was efficacious, safe and well-tolerated although the small N limits generalizability to larger populations. Additional study is needed to evaluate longer term patient acceptance and satisfaction. This EPAP device presents a potential viable alternative to PAP therapy for mild-to-moderate OSA.