Sleep Med Psychophysiol.  2016 Dec;23(2):84-92. 10.14401/KASMED.2016.23.2.84.

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

• Kim HW
• Hwang C
• Eun HJ

• KMID: 2369057
• DOI: http://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.

Keyword

Sleep; Obstructive sleep apnea; Oral appliance; Mandibular advancement

MeSH Terms

Humans
Mandibular Advancement*
Oxygen
Prospective Studies*
Sleep Apnea, Obstructive*
Oxygen