NCT02885844

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

September 1, 2014

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

March 8, 2016

Completed
6 months until next milestone

First Posted

Study publicly available on registry

September 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

September 1, 2016

Status Verified

May 1, 2016

Enrollment Period

3 years

First QC Date

March 8, 2016

Last Update Submit

August 26, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Response time

    the time between when the target or shape appears and the subject lifts their finger off of the screen

    During flight

Secondary Outcomes (2)

  • Task duration

    During flight

  • Accuracy

    During flight

Study Arms (2)

INVERTED VISION

EXPERIMENTAL

inverted vision (upside down) using commercial off-the-shelf inverting prism goggles

Procedure: INVERTED VISION

NORMAL VISION

ACTIVE COMPARATOR

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.

Procedure: NORMAL VISON

Interventions

The tasks will be performed either with normal or inverted vision (upside down) using commercial off-the-shelf inverting prism goggles

INVERTED VISION
NORMAL VISONPROCEDURE

subject's field of view will be restricted by goggles without lenses in order to be equivalent to the inverted vision one.

NORMAL VISION

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Person with medical history of oculomotor disorders
  • Person with medical history of vestibular disorders
  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Caen

Caen, 14000, France

RECRUITING

Study Officials

  • Clément GC Gilles

    International Space University

    STUDY DIRECTOR

Central Study Contacts

Pierre DP Denise, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2016

First Posted

September 1, 2016

Study Start

September 1, 2014

Primary Completion

September 1, 2017

Study Completion

October 1, 2017

Last Updated

September 1, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share

Locations