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Completed

NCT Number: NCT02517177

Alterations in Autonomic Cardiovascular Control Induced at Partial G Forces

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.

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Key information

Conditions

Healthy

Age range

20 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Umr Ucbn/Inserm U1075 Comete

Caen, Basse-Normandie, 14032, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Parabolic flight

Other

Cardiovascular parameters measurements

Other

Primary outcomes

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

    Time frame: baseline

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

    Time frame: baseline

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

    Time frame: baseline

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

    Time frame: baseline

Sponsors and collaborators

Lead sponsor

University Hospital, Caen

Other

Registry information

Acronym: AUTOCARD

Important dates

Study start
2011
Primary completion
2012
First posted
Aug 6, 2015
Registry last updated
Aug 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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