Evaluation of the Effects of Mandibular Advancing Device in Obstructive Sleep Apnea Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- change in AHI
研究概览
简要总结
The goal of this clinical trial is to learn if Mandibular advancing devices work to treat obstructive sleep apnea in adults. Selected Participants have a mild or moderate degree of obstructive sleep apnea.The main questions it aims to answer are:
Do Mandibular advancing devices (MADs) lower the number of times participants experience apneas or hypopneas during sleep? Do MADs lower Apnea Hypopnea Index in adults when worn during sleep?
详细描述
This clinical trial aims to evaluate comprehensively the effects of a custom made titrable bi-block mandibular advancing device on the respiratory variables in polysomnography. This includes the apnea hypopnea index and the oxygen desaturation index. Also sleep variables such as sleep efficiency and snoring duration are evaluated. Also cone beam computed tomography scans are taken before treatment and after 6 weeks of using te appliance. the second CBCT scan is taken with the appliance intra-orally. The cahnge in airway volume and minimal axial area are measured.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (18 years and older)
- •Mild/Moderate obstructive sleep apnea
- •Sufficient number of teeth( having at least one terminal molar)
- •Healthy teeth and Periodontal ligament
- •Good physical and mental capability helping the subjects to be able to deal with the appliance.
排除标准
- •Severe OSA,
- •Central sleep apnea,
- •Pregnant females
- •Somatic or psychological disease, or medications for psychological conditions.
研究组 & 干预措施
mild-moderate obstructive sleep apnea subjects
receiving mandibular advancing devices
干预措施: Mandibular advancement device (Device)
结局指标
主要结局
change in AHI
时间窗: frpm enrollment to assessment of outcomes at least 8weeks
difference between pre-tretment and post-treatment Apnea Hypopnea Index
次要结局
未报告次要终点