NCT02763813终止不适用
Comparison of a Retention Type and Propulsion Type Oral Appliance in the Treatment of Obstructive Sleep Apnea
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Hopital Foch
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Apnea/hypopnea index (as measured from a level 1 or 2 polysomnography)
研究概览
简要总结
Monocentric comparative group study comparing the efficacy and short-term tolerance of a propulsion type oral appliance (Herbst) with a retention type device (ORM) used in the treatment of sleep apnea syndrome. The investigators hypothesized both appliances would be equally effective and tolerated.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sufficient teeth to allow wearing of the device
- •Mild to severe OSAS
- •Ability to answer the questionnaires
- •No concomitant CPAP treatment
- •BMI inferior to 32 kg/m2
排除标准
- •Important dental or parodontal disease
- •Central sleep apnea
- •Jaw opening limitations
- •Temporo-mandibular joint dysfunction
- •Major gag reflex precluding the long-term use of the device
- •Major or unstable cardiovascular or pulmonary disease
结局指标
主要结局
Apnea/hypopnea index (as measured from a level 1 or 2 polysomnography)
时间窗: 12 months
次要结局
未报告次要终点
研究者
研究点 (2)
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