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.

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.

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.