0548 A Multi-Centre Evaluation of a Mouthpiece Device for The Treatment of Obstructive Sleep Apnea Syndrome

Abstract

Introduction: Continuous positive airway pressure (CPAP) devices are considered as the first line therapy for obstructive sleep apnea syndrome (OSAS). However, there is an increasing tendency to use oral appliance as an alternative treatment due to poor patient compliance of CPAP devices. The evaluation of the oral appliances in the treatment of OSAS are conducted via magnetic resonance image (MRI) segmentation of upper airway structures and polysomnographic variables. This study aims to evaluate the efficacy of a mouthpiece device (DormioTM, Respo Gadgets) on patients with OSAS by the comparison of oropharyngeal volume and polysomnographic variables with and without the device. The study is reorganized as multi-center and blinded clinical trial. The mouthpiece device increases intraluminal pressure by using patients” own breath while reshaping the lower jaw and tongue position. Methods: Each patient (targeted n=24) underwent MRI of the upper airway during wakefulness at baseline and with the novel mouthpiece device. Since the proposed novel mouthpiece device design allows patient to breathe orally, the oropharyngeal volume change has been evaluated instead of the velopharyngeal volume. The oropharyngeal volumes of the participants have been reconstructed as 3D models from the acquired MRI images. After wards, The patients attended the sleep laboratory in 5 centers on two nights with and without the mouthpiece device for full diagnostic polysomnography. After the diagnose night, the patients had a 7-days acclimatization period with the mouthpiece and their 8th night was recorded in the sleep laboratory. Total apnoea-hypopnea index (AHI) and oxygen-desaturation index were scored blindly using AASM criteria. Results: The results (current n=12) show that the use of proposed device enlarged the oropharynx volume 71% on average while reducing the apnea hypopnea index by 53% on average. On the other hand, the polysomnographic variables have been significantly improved by the use of novel mouthpiece device. The oxygen desaturation index reduced 94% on average. Lowest oxygen saturation values improved 3.6% on average. Conclusion: The clinical results show that the proposed mouthpiece design offers a promising alternative oral appliance for OSAS patients.