Pilot Study of a New Mandibular Advancement Device

Abstract

This study was conducted to determine the efficacy of a customized mandibular advancement device (MAD) in the treatment of obstructive sleep apnea (OSA). Eight patients (M = 3; F = 5; mean age = 56.3 ± 9.4) with a diagnosis of OSA confirmed by polysomnography (PSG) were re-cruited on the basis of the following inclusion criteria: apnea-hypopnea index (AHI) > 5, age between 18 and 75 years, body mass index (BMI) < 25, and PSG data available at baseline (T0). All were treated with the new NOA® MAD by OrthoApnea (NOA® ) for at least 3 months; PSG with NOA in situ was performed after 3 months of treatment (T1). The following parameters were calculated at T0 and T1: AHI, supine AHI, oxygen desaturation index (ODI), percentage of recording time spent with oxygen saturation <90% (SpO2 < 90%), and mean oxygen desaturation (MeanSpO2%). Data were submitted for statistical analysis. The baseline values were AHI = 21.33 ± 14.79, supine AHI = 35.64 ± 12.80, ODI = 17.51 ± 13.5, SpO2 < 90% = 7.82 ± 17.08, and MeanSpO2% = 93.45 ± 1.86. Four patients had mild OSA (5 > AHI < 15), one moderate OSA (15 > AHI < 30), and three severe OSA (AHI > 30). After treatment with NOA®, statistically significant improvements in AHI (8.6 ± 4.21) and supine AHI (11.21 ± 7.26) were recorded. OrthoApnea NOA® could be an effective alternative in the treatment of OSA: the device improved the PSG parameters assessed.