a Single Blind Cross Over Trial to Compare Osteopathic Compression of Pterygopalatine Node to Placebo Compression in Obstructive Sleep Apnea Syndrome.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- pharyngeal critical pressure
研究概览
简要总结
The main objective is to evaluate an osteopathic compression of pterygopalatine node on sleep obstructive apnea syndrome (OSA).
详细描述
Osteopathic compression will be compared to a placebo manoeuvre. Efficacy will be assessed by measuring pharyngeal collapsibility
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
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
- •Male or Female aged 18 years or more
- •obstructive sleep apnea syndrome with apnea/hypopnea index > or = 15/hour
- •Body mass Index <40kg/m2
排除标准
- •pregnant or lactating women
- •participating to another trial
- •acute infectious disease of upper respiratory airway tract at inclusion
- •facial neuralgia at inclusion
- •patients not able to stop treatment for OSA within one week before each visit
- •allergy to latex
- •dental extraction within 15 days before inclusion
- •pharyngeal surgery in the past
- •incapable adult
研究组 & 干预措施
active osteopathic compression
osteopathic compression of Pterygopalatine node
干预措施: osteopathic compression of Pterygopalatine node (Procedure)
placebo osteopathic compression
placebo osteopathic compression
干预措施: osteopathic compression of Pterygopalatine node (Procedure)
结局指标
主要结局
pharyngeal critical pressure
时间窗: 30 minutes after osteopathic compression
The collapsibility of the upper airway will be evaluated by pharyngeal critical pressure,assessed by measuring the intraluminal pressure associated with the cessation of airflow
次要结局
- pharyngeal critical pressure(48 hours)
- symptoms(48 hours)
- adverse events(48 hours)
研究者
Valerie Attali
MD
Groupe Hospitalier Pitie-Salpetriere