NCT01822743已完成3 期
A Single Blind Cross Over Trial to Compare Osteopathic Compression of Pterygopalatine Node to Sham in Patients With Obstructive Sleep Apnea Syndrome and in Healthy Subjects
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Apnea-hypopnea index
研究概览
简要总结
The main objective is to evaluate an osteopathic compression of pterygopalatine node in healthy subjects and patients suffering from obstructive apnea syndrome (OSA).
详细描述
Osteopathic compression will be compared to a sham manoeuvre in a cross over design on apnea hypopnea index, pharyngeal collapsibility and symptoms in patients suffering from OSA, and on symptoms and pharyngeal collapsibility in healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Obstructive sleep apnea syndrome patient:
- •Inclusion criteria :
- •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
- •Complete nasal obstruction
- •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
- •Patients treated with Selective Serotonin Reuptake Inhibitor
- •Healthy Volunteers
- •Inclusion criteria :
- •Male or Female aged ≥18 and ≤ 40 years
- •No obstructive sleep apnea syndrome
- •Body mass Index <30kg/m2
- •No chronicle respiratory, neurological, cardiac or able to deteriorate sleep quality disease
- •Low obstructive sleep apnea syndrome probability measured with Berlin Scale
- •Exclusion criteria :
- •Pregnant or lactating women
- •Participating to another trial
- •Acute infectious disease of upper respiratory airway tract at inclusion
- •Complete nasal obstruction
- •Facial neuralgia at inclusion
- •allergy to latex
- •dental extraction within 15 days before inclusion
- •pharyngeal surgery in the past
- •incapable adult
- •patients treated background treatment
研究组 & 干预措施
Osteopathic manipulative treatment
Experimental
Osteopathic compression of pterygopalatine node
干预措施: Osteopathic manipulative treatment (Procedure)
Sham comparator
Sham Comparator
sham Osteopathic pterygopalatine node compression
干预措施: sham comparator (Procedure)
结局指标
主要结局
Apnea-hypopnea index
时间窗: 24 hours
次要结局
- Pharyngeal sensitivity test(24 hours)
- Determination of pharyngeal critical pressure(30 min)
- Daily clinical symptoms of osa(7 days)
- Inspiratory nasal pic flow(24 hours)
- Inspiratory nasal pic flow(30 min)
- Pharyngeal sensitivity test(30 min)
- Determination of pharyngeal critical pressure(24 hours)
研究者
研究点 (1)
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