Sleep Medicine and Psychophysiology (수면정신생리)

KOREAN ACADEMY OF SLEEP MEDICINE (대한수면의학회)
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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

  • Received : 2016.12.07
  • Accepted : 2016.12.21
  • Published : 2016.12.31
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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.

목 적 : 본 연구의 목적은 폐쇄성 수면무호흡증의 치료에 사용되는 하악전방이동장치의 한 제품인 '바이오가드'의 유효성과 안정성을 확인하는 것이다. 방 법 : 코골이 및 수면무호흡으로 내원한 총 62명의 환자를 대상으로 하여 하악전방이동장치를 치료법으로 선택하여 전향적, 다기관, 비열등성 연구를 하였다. 일차적으로 설문지 및 야간수면다원검사를 통해 수면무호흡지수의 변화를 수술적 치료의 선행 연구 결과와 비교한 비열등성 연구를 하였고 이차적으로 수면의 질, 주간졸리움, 산소포화도, 코골이 비율의 변화를 '바이오가드' 사용전후와 비교하였다. 또한 이상반응발생을 조사하여 안정성을 평가하였다. 결 과 : 62명의 환자 중 중도 탈락한 3명을 제외한 59명에게서 MAD 치료 5주 뒤에 평가한 수면무호흡지수의 변화는(54%) 수술적 치료의 선행 연구 결과(45%)와 비교하여 통계적으로 유의한 차이를 보이지 않았다(95% CI). 코골이 비율의 변화를 제외하고 수면무호흡지수, 수면의 질, 주간졸림증, 산소포화도는 통계적으로 유의한 개선을 보였다(p < 0.001). 총 62명 중 39명(62.9%)의 대상자에게서 총 85건의 이상반응이 보고되었으며 대부분(78건, 91.8%)의 경우 경증으로 보고되었고 중증으로 보고된 2건의 경우는 바이오가드와의 연관성은 없는 것으로 밝혀졌다. 결 론 : 하악전방이동장치의 한 제품인 '바이오가드'는 코골이와 수면무호흡 환자에게 안전하고 효과적인 치료방법이다. 따라서 기존의 비가역적인 수술 치료법을 시도하기 전에 적용하는 대체치료법으로써 우선적으로 고려하여 사용할 수 있을 것이다.

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References

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