Evaluating the Clinical Performance of a Novel, Precision Oral Appliance Therapy Medical Device Made Wholly From a Medical Grade Class VI Material for the Treatment of Obstructive Sleep Apnea.

Objective The objective of this study is to evaluate the clinical performance of a novel, precision, oral appliance therapy (OAT) medical device made entirely from a US Pharmacopeia (USP) medical grade class VI qualified material for the treatment of obstructive sleep apnea (OSA). Methods This was a multi-center, single-arm, chart-based, retrospective study of 91 patients diagnosed with OSA, treated utilizing a novel, precision, OAT medical device. Performance criteria were overall efficacy (reduction of OSA events to less than 10 per hour); efficacy for patients with severe OSA (reduction of OSA events to less than 20 per hour and a 50% improvement); and compliance (the rate of continuation of treatment after at least a one-year follow-up, or, conversely, the rate of discontinuation of treatment due to material-related adverse events or side effects after one year).  Results Eighty-nine percent of all subjects diagnosed with all levels of OSA severity were successfully treated to an apnea hypopnea index ("AHI") < 10 events per hour. Ninety-eight percent of subjects diagnosed with mild to moderate OSA were successfully treated to an AHI < 10. Eighty percent of subjects with severe OSA, without screening or excluding subjects for airway collapse profile, were successfully treated to an AHI < 20 with a 50% improvement in AHI. After a minimum one-year follow-up period, 96% of patients were confirmed to remain in active treatment. No subjects were reported to discontinue treatment due to adverse events or side effects. Conclusions This novel, precision OAT medical device made from the USP Class VI qualified material demonstrated efficacy and safety for the treatment of patients with OSA.