OSAS Therapy and AIR MAD: New Design

Introduction: Obstructive Sleep Apnea Syndrome (OSAS) is a respiratory disorder. Mandibular Advancement Devices (MADs) are employed as an alternative to nasal continuous positive airway pressure (CPAP) therapy. The purpose of this study is to present a new design for the AIR MAD device. Materials and Methods: AIR MAD is a digital medical device for OSAS, that is designed using CAD software on a digital model obtained from an optical digital scanner and manufactured in PA12 polymer with 3D printer. The Appliance is made by two bites plane, one maxillary and one mandibular, and two lateral Airv mechanism, one on the left and the other one on the right of the appliance. The lateral mechanisms are made by a removable spacers, that you can put and remove vertically through an insert, exploiting the elasticity of the PA12. Those spacers are provided with the appliance as a kit made by two different stick, one for left and one for right part, were each spacer increase by 1mm for every advancing step. 24 adult patients (17 men and 7 women) were recruited 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). Results: The data were subjected to statistical analysis. The baseline values were as follows: AHI = 33.91 ± 14.15, supine AHI = 45.77 ± 16.25, ODI = 25.48 ± 12.52, Min SpO2 = 81.42% ± 5.76%, and Mean SpO2 = 92.57% ± 1.75%. After treatment with AIR MAD, statistically significant improvements were observed in AHI (6.83 ± 2.79) and supine AHI (15.7 ± 19.05). Of the 24 patients involved, 7 discontinued the treatment, with 4 of them citing the bulkiness of the device, a common limitation of two-piece devices. In response, the design was modified to improve compliance. The lateral modules were reduced by 30%, the Air Bite was limited to the canines, and the posterior thickness was reduced from 2.5 mm to 1.4 mm. Conclusions: The new design of AIR MAD could be an effective alternative for the treatment of OSAS, offering improved portability of the device.