DRIVing Simulator and People With NeuroCognitive Disorders

NCT ID: NCT06320639

Last Updated: 2024-03-20

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-10-03
• Study Completion Date: 2026-10-10

Brief Summary

The ageing of the population is leading to an increasing number of older drivers on the roads. At the same time, the proportion of older people with pathological ageing and neurocognitive disorders (NCD) is increasing. In terms of road safety, this raises the question of whether these drivers should continue to drive or not. People with NCDs may not be aware of the presence, extent and progression of their cognitive impairment and the impact it can have on daily life, including driving.

Despite their loss of autonomy and medical advice, 22% of people with major NCD continue to drive. In addition, the presence of minor NCD also puts people at a higher risk of road accidents.

However, several studies demonstrated that an NCD does not lead to a systematic and immediate impairment of driving ability and abruptly stopping driving leads to health problems, such as the risk of depression and greatly reduces quality of life.

It is therefore relevant to focus research on driving with people with NCD in order to have a reliable indicator of the person's abilities and the impact of their cognitive impairment on driving activity. The proposed study seeks to meet this need by studying the performance of people with NCD on a driving station (mini-simulator) while assessing their ability to evaluate their performance.

To achieve this goal, people with NCDs will perform tasks on a driving simulator. In addition, after each task on the driving simulator, they will answer questions about how they evaluate their own driving. Two assessors will observe the participants' driving and will estimate their driving performance. By comparing the driver's self-assessment with the assessors' assessment, an "awareness score of driving ability" will be calculated to determine whether the driver correctly assessed his or her performance.

Another project already underway aims to collect similar data from people without a diagnosis of NCDs (control group).

The principal objective of the present study is to compare the driving performance in a simulator and the awareness of driving ability of people with NCDs with those of a control group. Secondary objectives are :

1. to measure driving performance in a simulator and awareness of driving abilities (i.e. self-assessment skills) of people with NCDs.

2. to analyse driving performance and awareness of driving abilities according to the diagnosis and severity of the disorder (i.e. minor or major neurocognitive disorders).

3. to establish a methodology to identify a driver at risk of dangerous driving.

It is mainly an exploratory study however some hypotheses can be made :

• The driving performance and awareness of driving skills of people with NCDs are poorer compared to those of older, control individuals.
• Individuals' driving performance and awareness of driving ability are lower in the presence of major NCDs compared to minor NCDs.

Conditions

Neurocognitive Disorders

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Eligibility Criteria

Inclusion Criteria

• Diagnosed with Neurocognitive Disorders according to the Diagnostic and Statistical Manual of Mental Disorders-V (DSM-V)
• Normal or corrected vision
• B licence holder with 3+ years driving experience
• Active drivers or drivers who stopped driving less than 2 months ago (time between the medical consultation and the day in the day care hospital)
• For participants able to give consent:

• Written informed consent to participate in the study
• Informed consent of the participant in the presence of his/her curator.
• For participants who are not able to receive information and to give consent:

• Written informed consent of the legal representative (tutor) for participants under tutelage.
• Signature of a relative (family member and/or trusted person) of the participant
• The participant has to be affiliated to a social security scheme.

Exclusion Criteria

• History of epilepsy
• People with vestibular disorders, motion sickness or migraines
• Psychiatric history (e.g. schizophrenia)
• Non-stabilized use of antidepressants and/or anxiolytics (started or modified within the last 3 months)
• History of alcoholism
• Use of anti-epileptics
• Osteo-articular pathologies compromising walking

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: collaborator

University Gustave Eiffel

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hôpital des Charpennes

Villeurbanne, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Maud Ranchet, PhD

Role: CONTACT

maud.ranchet@univ-eiffel.fr

0472142599

Marion Giroux, PhD

Role: CONTACT

marion.giroux@chu-lyon.fr

0472432372

Facility Contacts

Marion Giroux, PhD

Role: primary

marion.giroux@chu-lyon.fr

0472432372

References

Delphin-Combe F, Coste MH, Bachelet R, Llorens M, Gentil C, Giroux M, Paire-Ficout L, Ranchet M, Krolak-Salmon P. An innovative therapeutic educational program to support older drivers with cognitive disorders: Description of a randomized controlled trial study protocol. Front Neurol. 2022 Jul 18;13:901100. doi: 10.3389/fneur.2022.901100. eCollection 2022.

Reference Type: RESULT

PMID: 35923824 (View on PubMed)

Other Identifiers

UGustaveEiffel

Identifier Type: -

Identifier Source: org_study_id