Can Osteopathy and Expiratory Resistance be Used in Prevention and/or Treatment of Acute Mountain Sickness ? a Randomized Controlled Field Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Changes in Lake Louise Score from baseline to altitude continuous exposure.
研究概览
简要总结
The purpose of this research is to support a hypothesis that osteopathic manual medicine (OMM) and / or a 10 cmH2O end-expiratory pressure (PEEP) could be used in the prevention of acute mountain sickness (AMS).
During altitude exposure, an exaggerated hypoxemia and the increase of intracranial pressure are both known to be major physipathological ways of AMS development.
The goal of the osteopathic protocol is to release tension on the circulatory structures directly related to cranial circulation and drainage. The main hypothesis is that it could lead to lower intracranial pressure and help reducing AMS signs. Furthermore the investigators would like to define a osteopathic score for individual AMS sensitivity, based on cranial bones mobility.
Several studies have shown that using PEEP at altitude (or hypoxia) increases SpO2. As for osteopathy protocol, the investigators would like to apply this experimental condition during real altitude exposure in a randomized controlled protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- 是
入选标准
- •Experienced alpinist
- •No previous acclimatization
排除标准
- •Heart failure, respiratory failure, kidney failure
- •Pregnant woman
结局指标
主要结局
Changes in Lake Louise Score from baseline to altitude continuous exposure.
时间窗: mesured and reported every hour during a 10 hours altitude exposure
Signs of acute mountain sickness regarding its severity according the official Lake Louise Score.
次要结局
- Changes in numeric scale of well being from baseline to altitude continuous exposure.(every hour during a 10 hours altitude exposure)
研究者
Hugo Nespoulet
Head of research
Institut de Formation et de Recherche en Médecine de Montagne