- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02885844
Effects of Inverted Vision on Pointing and Grasping in Parabolic Flight (SpaceInVision)
Parabolic flight is the only ground-based condition in which weightlessness (0G) can be created long enough for safely testing changes in human perception and behavior. In addition to the 0G period, parabolic flight generates equal duration periods of 1.8G, which present another unique opportunity to test the same responses to hypergravity and back to 1G.
Spatial orientation perception is a critical subsystem that is used by the central nervous system in the control of vehicles and other complex systems in a high-level integrative function. Evidence from space flight research demonstrates that spatial orientation is altered by the transitions in gravito-inertial force levels (Clément 2011; Clément & Reschke 2008), transitions corresponding to mission phases particularly critical for crew safety and mission success. Accurate perception of self-in-space motion and self-motion relative to other objects is critical for successful operations that involve motor control e.g. doing an extra-vehicule activity or piloting the spacecraft. To date, there is only limited operational evidence that these alterations cause functional impacts on mission-critical operations and control capabilities. Immediately after space flight, most crewmembers have reported some degree of disorientation/perceptual illusion, often accompanied by nausea (or other symptoms of motion sickness), and frequently manifested by lack of coordination, particularly during locomotion The hypothesis is that alteration in sensorimotor performance induced by inverted vision is gravity depend: maximum alteration during hypergravity, intermediary alteration during normal gravity, minimal alteration during weightlessness.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Caen, France, 14000
- Recruiting
- CHU Caen
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Subjects will be staff member of the team or of other teams participating in the parabolic flight campaign
- Healthy volunteers (men or women)
- Aged from 21 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
- 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
- Person with medical history of oculomotor disorders
- Person with medical history of vestibular disorders
- Pregnant women
Study Plan
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: NON_RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: INVERTED VISION
inverted vision (upside down) using commercial off-the-shelf inverting prism goggles
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The tasks will be performed either with normal or inverted vision (upside down) using commercial off-the-shelf inverting prism goggles
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ACTIVE_COMPARATOR: NORMAL VISION
During normal vision trials, subject's field of view will be restricted by goggles without lenses (see below) in order to be equivalent to the inverted vision one.
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subject's field of view will be restricted by goggles without lenses in order to be equivalent to the inverted vision one.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Response time
Time Frame: During flight
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the time between when the target or shape appears and the subject lifts their finger off of the screen
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During flight
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Task duration
Time Frame: During flight
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Only for the grasping task - the time between when the subject lifts their finger from the screen after having seen the shape, grasps the shape and touches the screen again.
This will also be measured for the time between when the subject touches the screen, places the shape in the correct form fitter and touches the screen again
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During flight
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Accuracy
Time Frame: During flight
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Only for the pointing task - the measured Euclidian distance from the target center to the coordinates of where the subject touched the screen.
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During flight
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Clément GC Gilles, International Space University
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2014-A00813-44
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.
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