NCT02517138

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Nov 2011

Longer than P75 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

November 1, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
1.6 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

1.3 years

First QC Date

July 23, 2015

Last Update Submit

August 5, 2015

Conditions

Healthy

Keywords

volunteers

Outcome Measures

Primary Outcomes (4)

  • eye movements

    measurements between normal gravity and microgravity hypergravity during parabolic flight

    Baseline

  • acceleration of the head

    measurements between normal gravity and microgravity hypergravity during parabolic flight

    Baseline

  • perception by the subjects of the right-front.

    measurements between normal gravity and microgravity hypergravity during parabolic flight

    Baseline

  • acceleration of the arms

    measurements between normal gravity and microgravity hypergravity during parabolic flight

    Baseline

Study Arms (1)

Measurements of eye movements and perception

OTHER
Other: Parabolic flightOther: Measurements of eye movements and perception

Interventions

Parabolic flightOTHER
Measurements of eye movements and perception
Measurements of eye movements and perceptionOTHER
Measurements of eye movements and perception

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • pregnant women.

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

November 1, 2011

Primary Completion

March 1, 2013

Study Completion

January 1, 2014

Last Updated

August 6, 2015

Record last verified: 2015-08

Locations

FR(1)