NCT02517177

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

July 23, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 6, 2015

Completed
Last Updated

August 6, 2015

Status Verified

August 1, 2015

Enrollment Period

1.5 years

First QC Date

July 23, 2015

Last Update Submit

August 5, 2015

Conditions

Healthy

Keywords

volunteers

Outcome Measures

Primary Outcomes (4)

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

    baseline

  • 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

Study Arms (1)

Cardiovascular parameters measurements

OTHER
Other: Parabolic flightOther: Cardiovascular parameters measurements

Interventions

Parabolic flightOTHER
Cardiovascular parameters measurements
Cardiovascular parameters measurementsOTHER
Cardiovascular parameters measurements

Eligibility Criteria

Age20 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • persons who take any medication or drugs influencing the autonomic cardiovascular control

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Umr Ucbn/Inserm U1075 Comete

Caen, Basse-Normandie, 14032, France

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2015

First Posted

August 6, 2015

Study Start

June 1, 2011

Primary Completion

December 1, 2012

Last Updated

August 6, 2015

Record last verified: 2015-08

Locations

FR(1)