NCT02850380

Brief Summary

The purpose of the study is to investigate spatial orientation in weightlessness as it manifests not in perception but rather in motor performance by direction and reaction time of flip switch. Hypotheses are that flip switch:

  1. 1.will be biased towards visual allocentric cues when those are available;
  2. 2.will be biased towards the egocentric reference when tactile cues are added;
  3. 3.will be dominated by egocentric cues when visual cues are not available;
  4. 4.will be delayed and more variable when confirmatory gravitational cues are absent;
  5. 5.will be faster and more reliable in absence of conflicting gravitational cues, and even more so when tactile cues are added;
  6. 6.The difference will be more pronounce when tested under Dual-task condition

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 healthy-volunteers

Timeline
Completed

Started Sep 2015

Longer than P75 for not_applicable healthy-volunteers

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 21, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 1, 2016

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

August 1, 2016

Status Verified

July 1, 2016

Enrollment Period

3 years

First QC Date

April 21, 2016

Last Update Submit

July 27, 2016

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

  • reaction time of flip switch measured with a chronometer

    baseline

  • Direction of flip switch measured with the circular instrument panel

    baseline

Study Arms (1)

spatial orientation in weightlessness

OTHER

subjects will be asked to flip a series of switches into the "off" position. On Earth, the "off" position corresponds to "down" in all three reference frames: the visual allocentric, the non-visual allocentric as well as the egocentric frames. We expect that flip direction will be dominated by visual allocentric cues when those are available, will be delayed and more variable when confirmatory gravitational cues are absent, and will be biased towards the egocentric reference when tactile cues are added

Other: FLIP SWITCHES "DOWN" IN WEIGHTLESSNESS

Interventions

FLIP SWITCHES "DOWN" IN WEIGHTLESSNESSOTHER

The circular instrument panel that subjects will see into the cylindrical mask consists of one switch surrounded by a luminous ring (left part of the figure below). The switch can be flipped into any direction within the full 360° range. The switch provides no visual cues about "down", but the experimenter can add such cues by means of visually polarized labelling displayed on a circular black screen at the center of the panel (right part the figure below).

spatial orientation in weightlessness

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 from 20 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.
  • Subjects will be staff member of the team or of other teams participating in the parabolic flight campaign

You may not qualify if:

  • Person who has already participated in a parabolic flight
  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Caen CHU

Caen, 14000, France

RECRUITING

MeSH Terms

Interventions

Weightlessness

Intervention Hierarchy (Ancestors)

HypogravityGravity, AlteredGravitationAstronomical PhenomenaPhysical Phenomena

Study Officials

  • Pierre DP Denise, PhD

    CHU CAEN

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pierre DP Denise, PhD

CONTACT

02.31.06.81.32pierre.denise@unicaen.fr

Cathy GC Gaillard

CONTACT

02 31 06 53 49gaillard-c@chu-caen.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2016

First Posted

August 1, 2016

Study Start

September 1, 2015

Primary Completion

September 1, 2018

Study Completion

September 1, 2018

Last Updated

August 1, 2016

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)