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.

Criteria for oral appliance and/or supine avoidance therapy selection based on outcome optimization and cost-effectiveness.

AIM: Produce empirical support for further enhancements to a therapy selection protocol for obstructive sleep apnea (OSA) patients intolerant of positive airway pressure. METHODS: A retrospective analysis was conducted in 101 men and 69 women patients. Two-night home sleep apnea studies were conducted at baseline and with a trial oral appliance. Twenty-minutes in-position sleep was required to compute supine and non-supine apnea-hypopnea indexes (AHI). Data analyses were applied after stratification by sex and response to oral appliance therapy (OAT), and the results used for to calculate incremental cost-effectiveness ratios (ICER). RESULTS: Compared with men, women had significantly lower pre-treatment supine and non-supine AHI values (p < .05). OAT non-responders had higher non-supine AHIs, resulting in less positional-OSA and more cases with severe OSA (p < .05). Across the cohort, 21% had positional-OSA with a pre-treatment non-supine AHI < 5 events/h. In those who met this criterion, supine avoidance therapy (SAT) could have reduced the AHI values more than OAT by an average of 33% (p < .0001). The ICER for SAT instead of OAT in this group was negative, a condition that only occurs when one therapy is both less expensive and more effective than the other. A greater proportion of non-responders had post-OAT overall AHI ≥ 10 events/h with residual positional-OSA compared with responders (p < .0001). Combination therapy could reduce the AHI values by an average of 68%, resulting in ICER estimates five-times less than the reimbursement decision-making threshold. CONCLUSIONS AND LIMITATIONS: Based on pre-treatment non-supine AHI values, SAT would provide a superior first-line treatment outcome as compared to OAT in 21% of patients diagnosed with OSA. SAT would also provide a cost-effective adjuvant to OAT in an additional 15% of cases. The benefit of SAT could not be determined in one-fifth of the cohort who slept exclusively supine.