Alterations in Autonomic Cardiovascular Control Induced at Partial G Forces

NCT ID: NCT02517177

Last Updated: 2015-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Brief Summary

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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

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Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Cardiovascular parameters measurements

Group Type OTHER

Parabolic flight

Intervention Type OTHER

Cardiovascular parameters measurements

Intervention Type OTHER

Interventions

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Parabolic flight

Intervention Type OTHER

Cardiovascular parameters measurements

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

35 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Caen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Umr Ucbn/Inserm U1075 Comete

Caen, Basse-Normandie, France

Site Status

Countries

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France

Other Identifiers

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11-008

Identifier Type: -

Identifier Source: org_study_id

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