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临床试验/NCT02517177
NCT02517177已完成不适用

Alterations in Autonomic Cardiovascular Control Induced at Partial G Forces

University Hospital, Caen1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2011年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
12
试验地点
1
主要终点
The systolic, diastolic and mean arterial blood pressure (SP, DP, MAP)

研究概览

简要总结

As a direct consequence of exposure to microgravity, astronauts experience a number of physiological changes which can lead to serious medical implications. Most immediate and significant is the headward shift of body fluids and the removal of gravitational loading from bone and muscles, resulting in progressive changes of the cardiovascular and musculoskeletal systems. The cardiovascular systems is subject to rapid changes which has been demonstrated in studies of short term (shuttle) and long term missions to Skylab and MIR.

Our main hypothesis is that there is a linear relationship between the gravity level (0G, 0.16G, 0.38G, 1G, 1.8G) and the cardiovascular parameters (heart rate (HR), heart rate variability (HRV), blood pressure and blood pressure variability (BPV) as well the spectral analysis of HRV and BPV.

研究设计

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

入排标准

年龄范围
20 Years 至 35 Years(Adult)
性别
Male
接受健康志愿者
是

入选标准

  • •healthy male volunteer
  • •aged from 20 to 35
  • •affiliated to a Social Security system and, for non-French resident, holding an European Health Insurance Card (EHIC)
  • •who accepts to take part in the study
  • •who has given their written stated consent
  • •who has passed a medical examination similar to a standard aviation medical examination for private pilot aptitude .There will be no additional test

排除标准

  • •persons who took part in a previous biomedical research protocol, of which exclusion period is not terminated,
  • •persons who take any medication or drugs influencing the autonomic cardiovascular control

研究组 & 干预措施

Cardiovascular parameters measurements

Other

干预措施: Parabolic flight (Other)

Cardiovascular parameters measurements

Other

干预措施: Cardiovascular parameters measurements (Other)

结局指标

主要结局

The systolic, diastolic and mean arterial blood pressure (SP, DP, MAP)

时间窗: baseline

The autonomic cardiovascular control evaluated with a spectral analysis of HRV and BPV.

时间窗: baseline

the blood pressure variability (BPV) derived from the continuous blood pressure recording

时间窗: baseline

The heart rate (HR) and the heart rate variability (HRV) derived from the ECG

时间窗: baseline

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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