Oral appliance therapy is highly efficacious at reducing sleep apnea-specific hypoxic burden, a metric predictive of cardiovascular morbidity and mortality.

Abstract

Study objectives: 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.

Methods: 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.

Results: 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.

Conclusions: 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.

Clinical trial registration: 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.