NCT03298139

Brief Summary

Although most ground studies showed that an egocentric reference frame better supports spatial orientation, it is not proven it will be the same during weightlessness. Although it might justify that visuomotor performance will be better supported by egocentric target cueing under altered gravity conditions, the fact that exocentric target cueing induces less head movements and called for least attentional and physiological workload could be the key factors for a more efficient task localization process. Moreover, weightlessness can induce spatial disorientation, which can be additionally influenced by the intrinsic and extrinsic spatial reference frames (Gurfinkel et al., 1993; Glasauer \& Mittelstädt, 1997, 1998; Harm et al., 1998; Lipshits et al. 2005). We expect that during weightlessness the workload will be the key factor and thus we hypothesize that an exocentric target cueing will outperform egocentric target cueing. To test this hypothesis, and find out which presentation scheme for target cueing (EGO, EXO, ED) contributes most to an efficient visual search, performance to a visuomotor task will be evaluated during parabolic flights in normogravity (1g), hypergravity (1.8g) and microgravity (0g). The visuomotor performance will be assessed by a multi-directional tapping task as defined by ISO9241-9, which requests for motor responses by aimed pointing movements. Besides analyzing the pointing performance, different workload indices will be additionally assessed to evaluate the effort spent on visuomotor coordination. The attentional workload will be evaluated by the performance of a secondary task (visual reaction-time task), which needs to be conducted in parallel to the visuomotor task. Furthermore, the workload will be also assessed subjectively by the NASA TLX rating scale and physiologically, by analyzing the heart rate variability (HRV).

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 Oct 2016

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

October 1, 2016

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

September 27, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 2, 2017

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

October 2, 2017

Status Verified

September 1, 2017

Enrollment Period

3.1 years

First QC Date

September 27, 2017

Last Update Submit

September 27, 2017

Conditions

Outcome Measures

Primary Outcomes (2)

  • visuomotor performance

    The visuomotor performance will be assessed by a multi-directional tapping task as defined by ISO9241-9, which requests for motor responses by aimed pointing movements.

    baseline

  • common external display guidance method (ED)

    common external display guidance method (ED) and exocentric "in-view" cueing (EXO), using common guidance method with an external display (ED) as a control condition

    baseline

Study Arms (1)

parabolic flights

EXPERIMENTAL

parabolic flights in normogravity (1g), hypergravity (1.8g) and microgravity (0g).

Other: 3 levels of gravity (1G, 1.8G, 0G).

Interventions

healthy volunteers will experience 3 levels of gravity (1G, 1.8G, 0G).

parabolic flights

Eligibility Criteria

Age18 Years - 67 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy volunteers (men or women)
  • Aged from 18 to 67
  • 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:

  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Caen

Caen, France

RECRUITING

Central Study Contacts

Pierre Denise, MD-PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2017

First Posted

October 2, 2017

Study Start

October 1, 2016

Primary Completion

October 31, 2019

Study Completion

December 31, 2019

Last Updated

October 2, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share

Locations