수면정신생리

수면정신생리 (23권2호 84-92)

Safety and Efficacy of the Mandibular Advancement Device 'Bioguard' for the Treatment of Obstructive Sleep Apnea : A Prospective, Multi-Center, Single Group, and Non-Inferiority Trial

폐쇄성 수면무호흡증의 치료에 사용되는 하악전방이동장치-'바이오가드'의 안전성과 유효성 검증을 위한 전향적, 다기관, 단일군 및 비열등성 연구

Kim, Hyoung Wook;Hwang, Chungpoong;Eun, Hun Jeong;

Department of Neuropsychiatry, Presbyterian Medical Center;Sleep & Health Co.ltd;Department of Neuropsychiatry, Presbyterian Medical Center;

DOI : http://dx.doi.org/10.14401/KASMED.2016.23.2.84

Abstract

Objectives: The purpose of this study was to estimate the safety and efficacy of a mandibular advancement device (MAD), ''Bioguard,'' for the treatment of obstructive sleep apnea (OSA). Methods: In this 5-week prospective, multi-center, single group, and non-inferiority trial, patients who chose ''Bioguard'' as their treatment option were evaluated using both questionnaires (Pittsburgh Sleep Quality Index (PSQI), Epworth sleepiness scale (ESS)) and polysomonography (PSG) (apnea hypopnea index (AHI), oxygen saturation). All patient data, including clinical records, PSG studies (both pre- and post-treatment), and adverse events (AEs), were reviewed and analyzed. Results: Results were obtained for 59 of 62 patients (95.16%). No significant difference in success rate was found between the MAD treatment and surgical treatment (95% CI). AHI, PSQI, ESS and oxygen saturation demonstrated significant improvement (p < 0.001) after MAD treatment, and 39 of 62 patients (62.9%) reported 85 AEs. 79 of the 85 AEs (91.8%) were mild cases, and there were no severe AEs related to the MAD treatment. Conclusion: The MAD ''Bioguard'' should be considered as an alternative treatment option for OSA patients.

Keywords

Sleep;Obstructive sleep apnea;Oral appliance;Mandibular advancement;