- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02517138
Right-front Direction in Parabolic Flight (DROITDEVANT)
August 5, 2015 updated by: University Hospital, Caen
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Basse-Normandie
-
Caen CEDEX, Basse-Normandie, France, 14032
- Umr Ucbn/Inserm U1075 Comete
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
OTHER: Measurements of eye movements and perception
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
eye movements
Time Frame: Baseline
|
measurements between normal gravity and microgravity hypergravity during parabolic flight
|
Baseline
|
|
acceleration of the head
Time Frame: Baseline
|
measurements between normal gravity and microgravity hypergravity during parabolic flight
|
Baseline
|
|
perception by the subjects of the right-front.
Time Frame: Baseline
|
measurements between normal gravity and microgravity hypergravity during parabolic flight
|
Baseline
|
|
acceleration of the arms
Time Frame: Baseline
|
measurements between normal gravity and microgravity hypergravity during parabolic flight
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2011
Primary Completion (ACTUAL)
March 1, 2013
Study Completion (ACTUAL)
January 1, 2014
Study Registration Dates
First Submitted
July 23, 2015
First Submitted That Met QC Criteria
August 5, 2015
First Posted (ESTIMATE)
August 6, 2015
Study Record Updates
Last Update Posted (ESTIMATE)
August 6, 2015
Last Update Submitted That Met QC Criteria
August 5, 2015
Last Verified
August 1, 2015
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 11-094
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.