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临床试验/NCT03303118
NCT03303118已完成不适用

The Effects of Hypobaria vs Hypoxia on Cerebral Vasoreactivity, Brain's Electrical Activity and Concentration Performance on Pilots.

Fliegerärztliches Institut2 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2017年11月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
17
试验地点
2
主要终点
Concentration performance

研究概览

简要总结

The investigators will investigate the effect of hypobaria and hypoxia on physiological responses such as: oxygen saturation, heart rate, cerebral blood flow, cerebral oxygenation, brain's activity and concentration performance.

详细描述

The main goal of this project is to investigate how hypoxia affects cognitive functions. The KLT-R test asses the concentration level of a person. Subjects will do this test at different simulated altitude level in the hypobaric chamber at the FAI in Dübendorf. Investigators' first hypothesis is that concentration level will be altered by hypoxia. The higher altitude the subjects are, the more the concentration would be altered. KLT-R performance would be impaired by hypoxia compare to sea level performance.

The primary endpoint of this project is to investigate how KLT-R performance is affected by the different hypoxic conditions. KLT-R test will be passed nine times in total during the test visit. There will be a pre-test; a test at each of the conditions (3000m HH, 5500m HH, 5500m NH and 5500m HN); between each condition at sea level (to have a new baseline before each condition) and a post-test at the end of the protocol. To avoid influence of fatigue, all conditions will be randomized.

The second endpoint of this study is how the brain electrical activity is modulated by hypoxia. Micro-states also will be measure during hypobaric hypoxia conditions (3000m HH and 5500m HH).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • No history of flight sickness
  • No relevant medical diseases
  • Age 18 - 40 years
  • Written consent acceptance

排除标准

  • Known pathologies
  • Relevant medical disorders
  • Drug addiction
  • Anemia or poor health
  • People who have already had problems with elevation

结局指标

主要结局

Concentration performance

时间窗: 4 minutes per test

Performance of concentration at different altitude levels.

次要结局

  • EEG micro-states(5 minutes per record)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mathias Aebi, PhD

Dr. med Denis Bron

Fliegerärztliches Institut

研究点 (2)

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