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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02517138
Other study ID # 11-094
Secondary ID
Status Completed
Phase N/A
First received July 23, 2015
Last updated August 5, 2015
Start date November 2011
Est. completion date January 2014

Study information

Verified date August 2015
Source University Hospital, Caen
Contact n/a
Is FDA regulated No
Health authority France: Agence Nationale de Sécurité du Médicament et des produits de santé
Study type Interventional

Clinical Trial Summary

The goal of this study is to objectively determine the perceived direction of the right-front by the subjects in weightlessness. The direction of the right-front has not been investigated to date with the measurements of the position of the eyes. The investigators will compare the intersection of the horizontal and vertical saccadic trajectories (jerky) with the apparent direction of the right-front indicated by the subjects when they look right front in the dark (LOOK) and that they indicate when they determine whether a visual target through the right-front apparent (PERCEPTION). Then, the investigators will compare these measurements between normal gravity and microgravity hypergravity during parabolic flight.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date January 2014
Est. primary completion date March 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 20 Years to 65 Years
Eligibility Inclusion Criteria:

- Healthy volunteers (men or women)

- Aged between 20-65 years

- Affiliates to a social security system

- Who are willing to take part in the study,

- Who gave written informed consent,

- Declared fit after a similar visit to a medical aeronautical medical fitness for the non-professional cabin crew in civil aviation. There will be no other aptitude tests for the selection of subjects.

Exclusion Criteria:

- People who participated in a biomedical research protocol for which the exclusion period is complete,

- pregnant women.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Other:
Parabolic flight

Measurements of eye movements and perception


Locations

Country Name City State
France Umr Ucbn/Inserm U1075 Comete Caen CEDEX Basse-Normandie

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary eye movements measurements between normal gravity and microgravity hypergravity during parabolic flight Baseline No
Primary acceleration of the head measurements between normal gravity and microgravity hypergravity during parabolic flight Baseline No
Primary perception by the subjects of the right-front. measurements between normal gravity and microgravity hypergravity during parabolic flight Baseline No
Primary acceleration of the arms measurements between normal gravity and microgravity hypergravity during parabolic flight Baseline No
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