3D Ballistocardiography in Microgravity

Study Overview
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Brief Summary
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3-D Ballistocardiography (BCG) recording was performed in microgravity during the Spacelab D2 missions on a single astronaut. The results from this experiment have been published in the literature: the influence of respiration have been demonstrated and the signal processing methodology for the reconstruction of the displacement in one cardiac cycle have been developed. A 3D-BCG sensor has been developed and a collaboration to perform a sustained microgravity experiment onboard the Russian segment of ISS has been initiated. To be integrated in the PNEUMOCARD device, this new sensor needs to be tested in microgravity before implemented on ISS. The aim of the present parabolic flight study is to serve as a feasibility demonstrator and test bed in order to evaluate the feasibility of 3D-BCG in sustained microgravity and to test whether the sensitivity of the developed 3D-BCG sensor is appropriate

Conditions
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Healthy

Intervention / Treatment
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* Other: Parabolic flight
* Other: Cardiovascular parameters measurements
* Device: 3D-BCG sensor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy volunteers (men or women) Aged from 18 to 65 Affiliated to a Social Security system and, for non-French resident, holding a European Health Insurance Card (EHIC) Who accepted to take part in the study Who have given their written stated consent Whose 4 chamber view of the heart during a breath hold is easy to get during a routine cardiac echocardiography (M-Mode - apical view). Who has passed a medical examination similar to a standard aviation medical examination for private pilot aptitude (JAR FCL3 Class 2 medical examination). There will be no additional test performed for subject selection. Exclusion Criteria: Person who took part in a previous biomedical research protocol, of which exclusion period is not terminated Difficulty to obtain a clear echocardiography. Pregnant women

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Cardiovascular parameters measurements<br> | Other: Parabolic flight<br> <br> Other: Cardiovascular parameters measurements<br>* with Ballistocardiography (BCG), electric cardiography (ECG), impedance cardiography (ICG) and echocardiography<br>Device: 3D-BCG sensor<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate | evaluated by BCG, ECG, ICG and echocardiography during the free-floating protocol | baseline | 
| stroke volume | evaluated by BCG, ECG, ICG and echocardiography during the free-floating protocol | baseline | 
| ejection fraction | evaluated by BCG, ECG, ICG and echocardiography during the free-floating protocol | baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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volunteers