Long-term Impact of Maxillomandibular Advancement Osteotomy on Sleep Apnea Patients (MIMOSA)
Evaluation of the Long-term Impact of Maxillomandibular Advancement Osteotomy on Patients With Obstructive Sleep Apnea Syndrome
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.
研究概览
地位
条件
研究类型
注册 (实际的)
参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- clinically confirmed diagnosis of OSAS
- treated with an MMA between 01/11/1995 and 01/12/1999 by one surgeon (CDC)
Exclusion Criteria:
- not following abovementioned criteria
学习计划
研究是如何设计的？
设计细节
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
apnea-hypopnea index, as determined through polysomnography
大体时间：minimum 15 years postoperative
|
minimum 15 years postoperative
|
|
oxygen saturation values, as determined through polysomnography
大体时间：minimum 15 years postoperative
|
minimum 15 years postoperative
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
evolution of patient quality of life, through Epworth Sleepiness Scale
大体时间：preoperative
|
preoperative
|
|
Stability of hard and soft head and neck tissue, according to manual anthropometry
大体时间：min 15 years postoperative
|
min 15 years postoperative
|
|
Evolution of apnea-hypopnea index, as determined through polysomnography
大体时间：preoperative
|
preoperative
|
|
Evolution of apnea-hypopnea index, as determined through polysomnography
大体时间：immediately postoperative
|
immediately postoperative
|
|
oxygen saturation values, as determined through polysomnography
大体时间：preoperative
|
preoperative
|
|
oxygen saturation values, as determined through polysomnography
大体时间：immediately postoperative
|
immediately postoperative
|
|
evolution of patient quality of life, through Epworth Sleepiness Scale
大体时间：immediately postoperative
|
immediately postoperative
|
|
evolution of patient quality of life, through Epworth Sleepiness Scale
大体时间：minimum 15 years postoperative
|
minimum 15 years postoperative
|
|
evolution of patient quality of life, through OSAS questionnaire
大体时间：preoperative
|
preoperative
|
|
evolution of patient quality of life, through OSAS questionnaire
大体时间：immediately postoperative
|
immediately postoperative
|
|
evolution of patient quality of life, through OSAS questionnaire
大体时间：minimum 15 years postoperative
|
minimum 15 years postoperative
|
|
evaluation of hard and soft head and neck tissue, according to cone-beam CT imaging
大体时间：minimum 15 years postoperative
|
minimum 15 years postoperative
|
合作者和调查者
调查人员
- 首席研究员：Nathalie Neyt、AZ Sint-Jan Brugge-Oostende AV
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他研究编号
- 2016/0876
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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