Alterations in Autonomic Cardiovascular Control Induced at Partial G Forces

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Other: Parabolic flight; Other: Cardiovascular parameters measurements

• Registration Number: NCT02517177
• Lead Sponsor: University Hospital, Caen

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06
• Primary Completion: 2012-12
• Study First Submitted: 2015-07-23
• Status Verified: 2015-08
• Study First Submitted QC: 2015-08-05
• Last Update Submitted: 2015-08-05
• Study First Posted: 2015-08-06
• Last Update Posted: 2015-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cardiovascular parameters measurements	Cardiovascular parameters measurements	-
Cardiovascular parameters measurements	Parabolic flight	-

Primary Outcome Measures

Name	Time	Method
The systolic, diastolic and mean arterial blood pressure (SP, DP, MAP)	baseline
The autonomic cardiovascular control evaluated with a spectral analysis of HRV and BPV.	baseline
the blood pressure variability (BPV) derived from the continuous blood pressure recording	baseline
The heart rate (HR) and the heart rate variability (HRV) derived from the ECG	baseline

Trial Locations

Locations (1)

Umr Ucbn/Inserm U1075 Comete; 🇫🇷 Caen CEDEX, Basse-Normandie, France