Decision-makingVASISNCT06255275
Impact of Perceptive, Executive and Emotional Factors on Decision-making of Pedestrian Face to Autonomous Vehicles.
A study testing neurocognitifs tests + pedestrian crossign whith virtual reality in people with Decision-making, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Decision-making
- What is being tested?
- neurocognitifs tests + pedestrian crossign whith virtual reality
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 8 Apr 2024to 8 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Perceptive, Executive and Emotional Factors on Decision-making in the Context of Pedestrian Crossing in an Industrial Environment Involving Traffic of Autonomous Vehicles (forklifts)
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).
- Conditions
- Decision-making
- Being tested
- neurocognitifs tests + pedestrian crossign whith virtual reality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neurocognitifs tests + pedestrian crossign whith virtual realityOther
Neurocognitive tests (attention, executive functions, reaction to difficulty). Assessment of anxiety and impulsivity + pedestrian crossign with virtual reality + post-crossing questionnaire
| Study group | Role | What they receive |
|---|---|---|
| pedestrian crossing - virtual reality | Experimental | Not described Receives: Other: neurocognitifs tests + pedestrian crossign whith virtual reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2024
- Study start8 Apr 2024
- Primary completion8 Jul 2024
- Study completion8 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Decision-makingStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Collaborators
- University of Franche-Comté
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06255275
- Sponsor's protocol ID
- 2023/787
- Acronym
- VASIS
- Status last verified
- Apr 2024
- First submitted
- 5 Feb 2024
- Last updated
- 26 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Perceptive, Executive and Emotional Factors on Decision-making in the Context of Pedestrian Crossing in an Industrial Environment Involving Traffic of Autonomous Vehicles (forklifts)
- ClinicalTrials.gov ID
- NCT06255275
- Acronym / sponsor ID
- VASIS / 2023/787
- Conditions
- Decision-making
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Collaborators
- University of Franche-Comté
- Study start
- 8 Apr 2024 (actual)
- Primary completion
- 8 Jul 2024 (actual)
- Study completion
- 8 Jul 2024 (actual)
- First posted
- 13 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pedestrian crossing - virtual reality | Experimental | Other: neurocognitifs tests + pedestrian crossign whith virtual reality |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| neurocognitifs tests + pedestrian crossign whith virtual realityNeurocognitive tests (attention, executive functions, reaction to difficulty). Assessment of anxiety and impulsivity + pedestrian crossign with virtual reality + post-crossing questionnaire | Other | pedestrian crossing - virtual reality |
Primary outcome
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.
Time frame: Day 0
Quantication of the time required for a pedestrian to cross safely, according to the attention of participants
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing neurocognitifs tests + pedestrian crossign whith virtual reality in people with Decision-making, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2024.