Obstructive Sleep Apnea afflicts an estimated 1 billion people worldwide. Untreated, Obstructive Sleep Apnea is linked with elevated levels of mortality, decreased quality of life and increased economic costs. However, several large population studies demonstrate that the efficacy of Continuous Positive Airway Pressure therapy, the most frequently prescribed treatment for Obstructive Sleep Apnea, is compromised by frequent refusals and terminations. As a result, healthcare providers are evaluating non-CPAP treatment options. Oral Appliance Therapy has emerged as a leading non-CPAP treatment for patients with Obstructive Sleep Apnea. Historically, healthcare providers have questioned the efficacy of Oral Appliance Therapy. Dozens of Oral Appliances are available to healthcare providers, with many contemporary Oral Appliances featuring improved designs, materials and technologies. This review investigates whether Oral Appliance design matters; do different Oral Appliance designs demonstrate different rates of efficacy? To the best of the authors’ knowledge, this is the first review to exclusively focus on scientific papers that report treatment success with Oral Appliances as a residual Apnea Hypopnea Index of less than 10 events per hour. Out of 272 source papers, the 27 papers included in this review encompass a pooled sample of 3799 patients treated with six distinctly different categories of Oral Appliance designs. Chi-squared and two-sided Fisher’s exact tests indicate significant differences in efficacy amongst Oral Appliance designs. These findings suggest that certain Oral Appliance designs can enable highly efficacious treatment for patients with Obstructive Sleep Apnea. Given these findings, healthcare providers should consider design when selecting an oral device for patients diagnosed with Obstructive Sleep Apnea.

Introduction: Oral appliances (OAs) for the treatment of obstructive sleep apnea (OSA) are often considered equivalent to one another due to their general mechanism of action, i.e., protrusion of the mandible. However, differences in appliance design, material, titration mechanism, and manufacturing techniques could impact efficacy. Objective: The objective of this study was to determine if precision OAs, defined as those that use digital manufacturing processes that replicate the bite position (bite transfer) with a high level of accuracy, have different efficacy than traditional OAs, defined as those that use fully or partially non-digital manufacturing processes and bite transfer. Methods: A review of the published literature and abstracts presented at scientific meetings was conducted. Sources were included if they used a commercial OA, stratified data by OSA severity, and provided data for the selected definition of efficacy (apnea-hypopnea index < 10 h-1). Results: 15 sources were identified for mild/moderate OSA and 12 for severe OSA. In mild/moderate OSA, the median efficacy was 92% (range: 85-98%) for precision and 75% (range: 30-85%) for traditional OAs. In severe OSA, the median efficacy was 59% (range: 52-76%) for precision and 50% (range: 38-61%) for traditional OAs. Of note, in the studies that presented data for mild OSA, precision OAs were efficacious in 100% of individuals (5 sources; pooled n = 109) while traditional OAs were only efficacious in 85% of individuals (7 sources; pooled n = 355). Conclusions: Precision OAs appear to be more efficacious than traditional OAs, resulting in better patient outcomes. Further studies are required to demonstrate the specific cause of this finding.

Obstructive Sleep Apnea is a highly prevalent respiratory disease linked with increased morbidity and mortality, reduced quality of life and increased economic costs if not treated. Oral Appliances are an emerging treatment option for Obstructive Sleep Apnea. This review concludes that many oral appliances marketed as “custom” include modifications and prefabricated items, and therefore do not meet the definition of “custom” oral appliances. This misclassification could hinder accurate characterization and appropriate utilization of oral appliances that do fulfill the definition of custom. To better inform clinical utilization of custom oral appliances, we propose further refining the custom oral appliance classification into semi-custom and precision-custom.

Obstructive sleep apnea is a highly prevalent respiratory disease linked to increased morbidity and mortality, a reduced quality of life, and increased economic costs if not treated. Oral appliances are an emerging treatment option for obstructive sleep apnea. This review concluded that many oral appliances marketed as “custom” include modifications and prefabricated items, and therefore do not meet the definition of “custom” oral appliances. This misclassification could hinder the accurate characterization, evaluation, and appropriate prescription of oral appliances. To better inform the clinical utilization of custom oral appliances and to more closely align sleep medicine with the benefits of personalized medicine, we propose that the custom oral appliance classification be further refined into semi-custom and precision-custom categories.

Obstructive Sleep Apnea is a highly prevalent disease effecting and estimated 1 billion people worldwide. Untreated, Obstructive Sleep Apnea is associated with elevated levels of mortality, decreased quality of life and increased economic costs. However, the strong efficacy of Continuous Positive Airway Pressure therapy, the most frequently prescribed treatment for Obstructive Sleep Apnea, is compromised by frequent refusal and termination rates. As a result, healthcare providers are evaluating non-CPAP treatment options for patients who terminate or refuse Continuous Positive Airway Pressure therapy. Oral Appliance Therapy devices have emerged as a leading alternative. With dozens of Oral Appliance Therapy devices available to healthcare providers, this review investigates whether different Oral Appliance Therapy device designs matter; are different Oral Appliance device designs associated with different levels of efficacy? This review evaluated 149 different source papers investigating the efficacy of Oral Appliance Therapy, yielding 39 unique papers that met the inclusion criteria, encompassing a pooled sample of 3,799 patients treated with six distinctly different Oral Appliance Therapy device designs. Chi-squared and two-sided Fisher’s exact tests revealed significant differences. As a result, healthcare providers and medical guidelines should consider Oral Appliance Therapy device designs when prescribing Oral Appliance Therapy for the treatment of Obstructive Sleep Apnea.

Introduction & Aim: Specific manufacturing designs and titration mechanisms characterize mandibular advancement devices (MAD) to treat obstructive sleep apnea (OSA). The present study investigates the impact of design and titration mechanism on the clinical efficacy of two MAD ‘s and their effects on positional sleep apnea. Methods: Preliminary data from 39 patients (22 Avant (AV) and 17 Flex (FX)) were analyzed (85% male, age: age: 54.1±0.9 years, body mass index (BMI): 27.9±3.9 kg/m² & apnea/hypopnea-index (AHI): 26.2±11.6 events/ hour). All patients were diagnosed with moderate to severe OSA (15≤AHI<65 per hour sleep) and BMI50% of baseline AHI and AHI with MAD <10 events per hour”. Results: Overall, 68% of patients achieved treatment success with AHI reduction from 26.2 to 9.1 events per hour of sleep (p<0.001). AV achieved 73% treatment success versus 59% for FX. Overall AHI reduction was 70% for AV (p<0.001) vs. 60% for FX (p<0.001). AHI-Supine reduction was 72% in AV (p<0.001) vs. 58% for FX (p<0.001). Conclusions: These preliminary data indicate that design and titration mechanism of MAD can impact the overall efficacy of MAD’s and may be an important consideration in general in OSA patients and, more in particular, in patients with supine-dependent respiratory events.