Alterations in Autonomic Cardiovascular Control Induced at Partial G Forces (AUTOCARD)

August 5, 2015 updated by: University Hospital, Caen

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Basse-Normandie
      • Caen CEDEX, Basse-Normandie, France, 14032
        • Umr Ucbn/Inserm U1075 Comete

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Cardiovascular parameters measurements
Other: Parabolic flight
Other: Cardiovascular parameters measurements

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Caen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

July 23, 2015

First Submitted That Met QC Criteria

August 5, 2015

First Posted (Estimate)

August 6, 2015

Study Record Updates

Last Update Posted (Estimate)

August 6, 2015

Last Update Submitted That Met QC Criteria

August 5, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 11-008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy

Clinical Trials on Parabolic flight

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in South Korea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe