NCT05056766已完成不适用
How Does the Clinical and Paraclinical Efficacy of an Oral Appliance Evolve According to Propulsion: Control With Each mm of Advancement"
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- apnea-hypopnea index
研究概览
简要总结
The OAMMM study is a mono-centrer , non interventional, prospective study, carried out in CH Valence
Oral Appliance is indicated for first line moderate sleep Apnea Syndrome or severe sleep Apnea Syndrome after failure of positive airway pressure (CPAP).
Clinical impact of each mm advancement of Oral Appliance is imperfectly assessed.
The study aim to assess clinical and paraclinical efficacy of an oral Appliance on each mm of advancement.
详细描述
Oral appliance will be delivered with a propulsion at 50% of the maximum advance and the investigator will titrate the advance according to the usual method
Polygraphy and clinical effectiveness of the Oral appliance will be evaluate
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years old
- •Moderate sleep apnea diagnosis with clinical signs
- •Severe sleep apnea with failure continuous positive airway pressure( CPAP)
排除标准
- •previous sleep apnea treatment for Moderate sleep apnea
- •refusal to participate in research
- •Patient under guardianship, deprived of liberty, safeguard of justice
结局指标
主要结局
apnea-hypopnea index
时间窗: 6 months
severity of sleep apnea
次要结局
- pichot fatigue questionnaire(6 months)
- Epworth Sleepiness Scale score(6 months)
研究者
研究点 (1)
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