Evaluation of the Long-term Impact of Maxillomandibular Advancement Osteotomy on Patients With Obstructive Sleep Apnea Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 主要终点
- apnea-hypopnea index, as determined through polysomnography
研究概览
简要总结
Background Maxillomandibular advancement surgery (MMA) has demonstrated high success rates, improving both the apnea-hypopnea index and associated patient' quality of life (QOL), in patients diagnosed with obstructive sleep apnea syndrome (OSAS). However, clinical relapse has been described in the target population, especially when associated with significant weight gain. Literature reporting the long-term impact of MMA for OSAS is lacking. The surgeons of the Division of Maxillofacial Surgery already started to perform this type of surgery in 1995.
Objectives The investigators aim to evaluate the long-term (minimum 15 years post-surgery) biologic and QOL impact of MMA in patients with OSAS. The biologic impact refers to the stability of hard and soft tissues and polysomnographic results.
Study design Retrospective study Both pre- en postoperative clinical imaging, polysomnography and quality of life questionnaires will be retrieved from all patients that were surgically treated with an MMA by one surgeon (CDC) between 01/11/1995 and 01/12/1999.
Conclusion Short-term data have shown high success rates for MMA in OSAS patients. However, long-term data are lacking. This retrospective study might provide us with more information about the incidence of clinical relapse fifteen to twenty years after surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinically confirmed diagnosis of OSAS
- •treated with an MMA between 01/11/1995 and 01/12/1999 by one surgeon (CDC)
排除标准
- •not following abovementioned criteria
结局指标
主要结局
apnea-hypopnea index, as determined through polysomnography
时间窗: minimum 15 years postoperative
oxygen saturation values, as determined through polysomnography
时间窗: minimum 15 years postoperative
次要结局
- Evolution of apnea-hypopnea index, as determined through polysomnography(immediately postoperative)
- Stability of hard and soft head and neck tissue, according to manual anthropometry(min 15 years postoperative)
- evolution of patient quality of life, through OSAS questionnaire(minimum 15 years postoperative)
- evaluation of hard and soft head and neck tissue, according to cone-beam CT imaging(minimum 15 years postoperative)
- evolution of patient quality of life, through Epworth Sleepiness Scale(minimum 15 years postoperative)
- oxygen saturation values, as determined through polysomnography(immediately postoperative)
研究者
Nathalie Neyt
maxillofacial surgeon, principal investigator
AZ Sint-Jan AV