NCT06255275

Brief Summary

The VASIS project aims to assess the impact of perceptual, executive and emotional factors on decision-making in the context of pedestrian crossing in an industrial environment involving autonomous vehicle traffic (forklift).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

February 5, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 13, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

April 8, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 8, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 8, 2024

Completed
Last Updated

November 26, 2024

Status Verified

April 1, 2024

Enrollment Period

3 months

First QC Date

February 5, 2024

Last Update Submit

November 22, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Evaluation of the impact of the attention of participants on decision-making in the context of pedestrian crossing (virtual reality), particularly on the time required to cross safely, in an industrial environment involving autonomous vehicle traffic.

    Quantication of the time required for a pedestrian to cross safely, according to the attention of participants

    Day 0

Study Arms (1)

pedestrian crossing - virtual reality

EXPERIMENTAL
Other: neurocognitifs tests + pedestrian crossign whith virtual reality

Interventions

Neurocognitive tests (attention, executive functions, reaction to difficulty). Assessment of anxiety and impulsivity + pedestrian crossign with virtual reality + post-crossing questionnaire

pedestrian crossing - virtual reality

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • subjects aged 18 to 45
  • no objection following submission of a non-objection form indicating that the subject has understood the purpose and procedures of the study and agrees to participate in the study and to comply with the requirements and restrictions inherent in the study

You may not qualify if:

  • legal incapacity or limited legal capacity
  • subject unlikely to cooperate with the study and/or poor cooperation anticipated by the investigator
  • pregnant or breast-feeding women
  • color-blind subject
  • history of cardiovascular disease
  • current psychiatric or neurological disorders (including self-reported diagnoses of epilepsy)
  • known vestibular disorders (prone to frequent dizziness or vertigo)
  • headaches or migraines
  • deafness
  • subjects under the influence of psychotropic substances (alcohol, drugs)
  • motor disorders likely to prevent crossing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Besançon University Hospital

Besançon, France

Location

Study Design

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

Study Record Dates

First Submitted

February 5, 2024

First Posted

February 13, 2024

Study Start

April 8, 2024

Primary Completion

July 8, 2024

Study Completion

July 8, 2024

Last Updated

November 26, 2024

Record last verified: 2024-04

Locations