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 aim of this study was to introduce a new tritable custom-made device in the treatment of OSAS. 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. 10 adult patients (7 men and 3 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 following parameters were calculated at T0 and T1: AHI, supine AHI, oxygen desaturation index (ODI), Min SpO2, and mean oxygen desaturation (MeanSpO2%). The data underwent statistical analysis. Baseline values were as follows: AHI = 30.2 ± 13.9, supine AHI = 41.94 ± 17.92, ODI = 27.4 ± 12.66, Min SpO2 = 80.8% ± 5.91%, and MeanSpO2% = 92.68% ± 1.71%. Two patients had mild OSA (5 < AHI < 15), three had moderate OSA (15 < AHI < 30), and five had severe OSA (AHI > 30). Following treatment with AIR MAD, statistically significant improvements were recorded in AHI (6.37 ± 2.56) and supine AHI (14.3 ± 15.54). Conclusions: AIR MAD could be an effective alternative in the treatment of OSA: the device improved the evaluated PSG parameters.
AIR MAD: pilot study on a new oral device for OSAS patients / Doneda, M., Petrelli, M.e., Longhi, C., Santagostini, A., Segu', M.. - (2024). (International Spring Meeting SIDO 2024 Verona 19-20 aprile 2024).
AIR MAD: pilot study on a new oral device for OSAS patients
Segu
2024-01-01
Abstract
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 aim of this study was to introduce a new tritable custom-made device in the treatment of OSAS. 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. 10 adult patients (7 men and 3 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 following parameters were calculated at T0 and T1: AHI, supine AHI, oxygen desaturation index (ODI), Min SpO2, and mean oxygen desaturation (MeanSpO2%). The data underwent statistical analysis. Baseline values were as follows: AHI = 30.2 ± 13.9, supine AHI = 41.94 ± 17.92, ODI = 27.4 ± 12.66, Min SpO2 = 80.8% ± 5.91%, and MeanSpO2% = 92.68% ± 1.71%. Two patients had mild OSA (5 < AHI < 15), three had moderate OSA (15 < AHI < 30), and five had severe OSA (AHI > 30). Following treatment with AIR MAD, statistically significant improvements were recorded in AHI (6.37 ± 2.56) and supine AHI (14.3 ± 15.54). Conclusions: AIR MAD could be an effective alternative in the treatment of OSA: the device improved the evaluated PSG parameters.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
