3D Ballistocardiography in Microgravity

NCT ID: NCT02517112

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

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

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

with Ballistocardiography (BCG), electric cardiography (ECG), impedance cardiography (ICG) and echocardiography

3D-BCG sensor

Intervention Type DEVICE

Interventions

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Parabolic flight

Intervention Type OTHER

Cardiovascular parameters measurements

with Ballistocardiography (BCG), electric cardiography (ECG), impedance cardiography (ICG) and echocardiography

Intervention Type OTHER

3D-BCG sensor

Intervention Type DEVICE

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

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 RECRUITING

Countries

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France

Facility Contacts

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Pierre Denise, MD PhD

Role: primary

332068214

Other Identifiers

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11-126

Identifier Type: -

Identifier Source: org_study_id

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