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临床试验/NCT02762175
NCT02762175招募中不适用

3D Volumetric Changes in the Upper Airway After Maxillomandibular Advancement in Obstructive Sleep Apnea Syndrome Patients and the Implication on Quality of Life: A Prospective Registry

AZ Sint-Jan AV1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2015年1月最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
150
试验地点
1
主要终点
postoperative apnea-hypopnea index, measured with polysomnography

研究概览

简要总结

Background

Obstructive sleep apnea syndrome (OSAS) is a sleep-related breathing disorder characterized by intense snoring and repetitive complete or partial obstructions of the upper airway during sleep together with daytime sleepiness. Several non-invasive therapeutical options exist, however, they do not offer a permanent improvement. Maxillomandibular advancement (MMA) surgery is a procedure which changes the upper airway in a permanent way.

Objectives

The investigators aim to develop a prospective database registering 3D volumetric changes of the upper airway and its anatomic subregions, the apnea-hypopnea index (AHI) and quality of life (QOL) of all consecutive patients eligible for MMA, performed by Dr. Neyt. Patient demographics, detailed virtual cone-beam computed tomography (CBCT) planning parameters, orthognathic surgery, polysomnographic and QOL data are being collected during consecutive visits within the framework of routine practice.

Design

A prospective, observational cohort study

Study center

General Hospital (AZ) Sint-Jan Brugge-Oostende

Population

The investigators would like to include all OSAS patients (AHI ≥ 5) requiring a MMA by Dr. Neyt starting from January 2015.

Endpoints

The investigators aim to collect data that could provide information about the advantages and disadvantages of the routinely performed 3D CBCT preoperative MMA surgery planning for OSAS patients, regarding 3D volumetric changes of the upper airway and its anatomic subregions and quality of life (QOL) in a subjective manner with the Epworth Sleepiness Scale (ESS) and the OSAS questionnaire and in an objective manner with evaluation of the apnea-hypopnea index (AHI).

Duration

In light of the continuous improvement of patient care, a database will be maintained from January 2015 onwards to enable registration of large-scale OSAS patient data.

Conclusions

Development of a database registering 3D CBCT planning, polysomnographic data and quality of life (QOL) of all consecutive patients eligible for MMA, will provide more information about potential patient, virtual planning and surgical factors influencing accuracy of MMA, and the associated biological benefits of this procedure on the upper airway volume, the AHI and general QOL. Moreover, registration of those results could function as a measurement of quality of care, or could be used for sample size calculation for future large multicenter prospective trials.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients of all ages
  • Patients of all genders
  • Patients diagnosed with OSAS, based on an AHI ≥ 5
  • All consecutive OSAS patients operated by N. Neyt from January 2015 onwards

排除标准

  • Patients not eligible according to abovementioned criteria
  • Patients with morbid obesity (BMI >35), if judged non-eligible by the treating surgeon

结局指标

主要结局

postoperative apnea-hypopnea index, measured with polysomnography

时间窗: 6-12 months

次要结局

  • quality of life, measured with OSAS questionnaire(4-12 months)
  • 3D volumetric changes of the upper airway, measured with cone-beam CT(4-6 months)
  • quality of life, measured with epworth sleepiness scale(4-12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nathalie Neyt

maxillofacial surgeon

AZ Sint-Jan AV

研究点 (1)

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