Mandibular Device as First-Line OSA Therapy Shows High Adherence, Effectiveness

Use of a mandibular advancement device as first-line therapy for obstructive sleep apnea (OSA) is highly effective, especially in those with severe OSA, and has high adherence rates, according to preliminary clinical trial findings presented at the American Thoracic Society (ATS) 2023 International Conference, held in Washington, DC, May 19 to 24.

In an ongoing clinical trial (ClinicalTrials.Gov Identifier: NCT05393531), researchers are assessing the effectiveness of a mandibular advancement device (MAD) as first-line therapy for patients with moderate to severe OSA.

The trial includes patients diagnosed with moderate to severe OSA with: (1) no history of continuous positive airway pressure (CPAP) or MAD; (2) oAHI at least 15 events/hour and less than 65 events/hour of sleep; (3) BMI less than 35kg/m2; and (4) central AHI less than 30% of total AHI. Of the 130 participants included in the trial thus far, the 3-month follow-up involving adherence measurements taken via thermo-microsensor and polysomnography has been completed by 50 patients (mean [SD] age 48 [11] years; 12% women; mean obstructive apnea/hypopnea index [oAHI], 24.7 [interquartile range, 17.7-31.3]; mean body mass index, 28.1 [3.0] kg/m²). Notably, 4 of the 50 patients were excluded from analyses due to compliance failure or loss to follow-up. In the current analysis, the researchers compared patients’ baseline and follow-up data using a nonparametric paired Wilcoxon signed-rank test.

The 46 patients analyzed included 15 with severe OSA (AHI≥30/hour) and 31 with moderate OSA (AHI ≥15/hour and <30/hour). The researchers found that 39 of these patients showed an AHI less than 15/hour using MAD, with 36 patients showing a decrease of at least 50% in AHI to less than 20/hour. Baseline overall AHI (27.2; interquartile range [IQR], 17.9-34.0) decreased to 9.1 (IQR, 5.5-12.5)/hour with MAD (P <.05). Median AHI decreased 74.2% among patients with severe OSA (87% with AHI<15 events/hour with MAD) and by 57.3% among patients with moderate OSA (84% with AHI<15 events/hour with MAD). The researchers noted a decrease in AHI of at least 50% and to less than 20/hour in all patients with severe OSA and in 65% of patients with moderate OSA.

In a subgroup analysis of 36 patients, MAD adherence averaged 6 hours per night, with MAD used for more than 5 hours per night by 75% subgroup participants.

In future analyses for this ongoing clinical trial, the investigators will compare MAD to continuous positive airway pressure (CPAP) with respect to effectiveness and patient preferences.

“In this ongoing clinical trial, MAD therapy as a first-line treatment option showed a high efficacy, especially in severe OSA patients, combined with high patients’ adherence,” the researchers concluded.

This article originally appeared on Pulmonology Advisor