NCT00213434已完成不适用
Prospective Evaluation of Mandibular Advancement by Herbst Device in the Treatment of Moderate Obstructive Sleep Apnea Syndrome
University Hospital, Rouen2 个研究点 分布在 1 个国家开始时间: 2001年11月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 试验地点
- 2
- 主要终点
- Comparison of polysomnographic data after 3 months of treatment by oral appliance in 2 groups: one with Herbst device adjusted in maximal mandibular advancement and a placebo group
研究概览
简要总结
The purpose of this study is to determine if the mandibular advancement by Herbst device is effective in the treatment of moderate obstructive sleep apnea patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Moderate sleep apnea syndrome (10 < Respiratory Disorder Index < 30)
- •Body mass index (BMI) < 35 Kg/m2
- •Able to give their informed consent
排除标准
- •Pregnant women
- •Professional drivers requiring continuous positive airway pressure (CPAP) treatment
- •Psychiatric disorders, and patients unable to realise to study
- •Severe respiratory pathology which could interfere with the study
- •Morpheic epilepsy
- •Benzodiazepines intake
- •Chronic nasal obstruction
- •Ear, nose, and throat (ENT) pathology requiring surgery
- •Previous uvulopalatoplasty surgery
- •Temporomandibular joint pathology
- •Gum disease
- •Insufficient number of teeth to apply the oral appliance
- •Mobile teeth
结局指标
主要结局
Comparison of polysomnographic data after 3 months of treatment by oral appliance in 2 groups: one with Herbst device adjusted in maximal mandibular advancement and a placebo group
次要结局
- Tolerance of the oral appliance
- Efficacy on clinical symptoms
- Feasibility of this therapeutic method
- Identification of predictive factors of efficacy
研究者
研究点 (2)
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