# Obstructive Sleep Apnea Treatment and the Evaluation of Clinical Effectiveness of Uniquely Designed Oral Appliance Therapy Device

## TL;DR

This study shows that a uniquely designed oral appliance can effectively treat mild to moderate sleep apnea with good patient adherence.

## Contribution

A uniquely designed oral appliance with an embedded adherence tracking chip is evaluated for treating OSA.

## Key findings

- Average wearing time was 7 hours/night with a significant reduction in apnea-hypopnea index.
- Mean disease alleviation was 62% with 4 hours/night of usage.
- The device was well tolerated and showed optimal comfort for first-time use.

## Abstract

Background: Continuous positive airway pressure (CPAP) has been considered first-line therapy for patients with obstructive sleep apnea (OSA); however, adherence to the therapy is suboptimal. Oral appliance therapy (OAT) is an alternative to CPAP that may lend to better patient adherence, quality of life, and overall patients’ effectiveness of therapy.

Methods: This was a prospective, single-site, non-randomized study to evaluate the clinical effectiveness of a uniquely designed OAT device with an embedded adherence tracking chip in the treatment of mild and moderate OSA patients over three months. The effectiveness of OAT therapy was defined as the numerical product of efficacy and adherence. The efficacy of the device was defined as the change from baseline in the apnea-hypopnea index (AHI). Adherence was based on usage for a minimum of 4 hours/night of use, for at least five out of seven nights a week.

Results: 45 participants fitted with the OAT device completed at least one follow-up visit and had recordable objective data. Average patient wearing time was 7 hours/night and a reduction of the AHI from 16.4 events/hour to 5.7 events/hour after three months of use. Mean disease alleviation (MDA), which serves as a measure of the overall therapeutic effectiveness, was 62% when looking at 4 hours/night of usage. As the comfort of the device is related to wearing time, subjective data indicated the optimum first-time fit of the device.

Conclusion: The study OAT device was well tolerated throughout the study. When both efficacy and adherence are considered, OAT can be a clinically effective tool to treat OSA.