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.

A surrogate metric of obstructive sleep apnea (OSA), sleep apnea-specific hypoxic burden (SASHB), predicts adverse health outcomes associated with the disease and may be useful in assessing therapeutic success. The purpose of this study was to compare outcome of mandibular protruding oral appliance therapy (OAT) using apnea-hypopnea index (AHI) and SASHB in a population with a spectrum of OSA severity. Individuals with mild, moderate, and severe OSA (n = 152) were treated with mandibular protruding oral appliance therapy (OAT) in a prospective observational study. Two-night home sleep apnea tests were used to determine baseline and outcome values of AHI and SASHB. Mean baseline SASHB differed by OSA severity strata, with 0%, 18%, and 95% the percent of study participants with mild, moderate and severe OSA, respectively, having values greater than 60%min/h. At outcome, these values were reduced to 0%, 0%, and 15%, respectively. For the entire population, therapeutic efficacy was 75% using AHI < 10 events/h as a response criterion and 95% using SASHB < 60%min/h as the criterion. Using a risk-predictive outcome surrogate to assess the efficacy of OAT yields a substantially higher estimate of therapeutic efficacy of OAT, particularly in patients with severe OSA. Registry: ClinicalTrials.gov; Name: Feasibility and Predictive Accuracy of an In-Home Computer Controlled Mandibular Positioner in Identifying Favorable Candidates for Oral Appliance Therapy; Identifier: NCT03011762; Registry: ClinicalTrials.gov; Name: Predictive Accuracy of MATRx Plus in Identifying Favorable Candidates for Oral Appliance Therapy; Identifier: NCT03217383; Registry: ClinicalTrials.gov; Name: Validation of a Simplified MATRx Plus; Identifier: NCT03812692.

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.

Objective: This study evaluates the efficacy of a novel approach to oral appliance therapy (“OAT”) for the treatment of obstructive sleep apnea (“OSA”). This novel approach utilizes a systemized, oximetry-informed, treatment protocol and a precision-custom oral appliance. Methods: Sixty consecutive patients diagnosed with OSA were treated at Sleep Better Austin (“SBA”) using a structured, multi-step protocol and a precision-custom oral appliance (ProSomnus EVO). Baseline and post-treatment apnea–hypopnea index (“AHI”) values were compared using a matched-pair design. The primary outcome was the percentage of patients achieving a residual AHI of <10 events/h. Secondary outcomes included severity classification improvement. Results: In total, 90% of patients achieved the primary endpoint, and 87% improved by at least one severity classification. The mean AHI improved by 63% from baseline with the precision-custom OAT in situ (p < 0.001). In the moderate-to-severe subgroup, AHI improved by 70%, with 100% of severe patients achieving a residual AHI of <20 and a ≥50% improvement, without patient preselection. No serious adverse events were reported, and all patients continued therapy at follow-up. Conclusions: Precision-custom OAT, when delivered through a standardized clinical protocol informed by oximetry, can be a highly effective and well-tolerated treatment for OSA. These findings support its broader adoption as a non-invasive alternative to continuous positive airway pressure (“CPAP”) and surgical interventions, particularly for patients seeking personalized, high-compliance solutions.

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.