0563 The Evaluation of a Revolutionary Custom-Made Oral Appliance Design on Effectiveness, Efficacy, and Compliance

Abstract

Abstract Introduction Evaluate the clinical effectiveness of the SomnoDent Avant with Bflex technology, a custom-made oral appliance therapy (OAT) device in the treatment of mild/moderate Obstructive Sleep Apnea (OSA) for naïve and PAP non-compliant patients. Hypothesis for the study was that the unique strap mechanism design of the appliance encouraged mouth closure and nasal breathing, would have high levels of effectiveness, particularly for supine sleepers. The evaluation of the initial fit of the device as well as patient’s and bed partner’s acceptance were also investigated Methods Prospective 90 day trial, participants age ≥ 18 with AHI of ≥10 to ≤30 events/hr. confirmed by using a WatchPAT, Home Sleep Apnea Testing (HSAT) device at baseline. Initial advancement of the lower jaw was 60%. Treatment effectiveness is derived from two endpoints: efficacy and compliance. The efficacy of the OAT is defined as the change from baseline in AHI, based on one and three-month HSAT. Efficacy was measured in supine, lateral and prone positions. Compliance data was obtained from the Dentitrac (BRAEBON Medical Corporation) chip embedded in the SomnoDent Avant device looking at usage for at least 4 hours per night for at least 5 out of 7 nights a week. Results Preliminary data from 50 participants (66% male, 35% female), age: 52.3 ± 11.8 yrs., BMI: 31.1. A statistically significant 3-month trend change from baseline AHI -11.0 ± 7 (37/37), Average usage:7.0hrs/night, ESS: 3 month change from baseline -3.3 ± 4.0 (80.0% improvement), FOSQ 10: 1.7 ± 2.2 (76.7% improvement). Adequate (first-time) fit of the device upon initial insertion 89.3%, bed partner sleep improvement 83.3%, and 88.9% would recommend the use of the Avant OAT device. Conclusion • SomnoDent Avant demonstrated high effectiveness in the treatment of OSA, particularly with supine dependent OSA participants. The unique design of the Avant strap likely acts to close the patient’s mouth, encouraging nasal breathing • Statistical improvement in the quality of life • Optimum first-time fit • Improvement in bed partner quality of sleep Support (if any) SomnoMed