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.
10.14401/KASMED.2016.23.2.84
- Author:
Hyoung Wook KIM
1
;
Chungpoong HWANG
;
Hun Jeong EUN
Author Information
1. Department of Neuropsychiatry, Presbyterian Medical Center, Jeonju, Korea. pmcnp96@gmail.com
- Publication Type:Multicenter Study ; Original Article
- Keywords:
Sleep;
Obstructive sleep apnea;
Oral appliance;
Mandibular advancement
- MeSH:
Humans;
Mandibular Advancement*;
Oxygen;
Prospective Studies*;
Sleep Apnea, Obstructive*
- From:Sleep Medicine and Psychophysiology
2016;23(2):84-92
- CountryRepublic of Korea
- Language:Korean
-
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.
