NCT06320639: DRIVS-NCD

DRIVing Simulator and People With NeuroCognitive Disorders

Recruiting now Last updated 20 March 2024

What this trial tests

trial in Neurocognitive Disorders in 150 participants. Currently enrolling.

Timeline

3 October 2023

Primary endpoint
10 October 2026

10 October 2026

Quick facts

Lead sponsor	University Gustave Eiffel
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	150
Start date	3 October 2023
Primary completion	10 October 2026
Estimated completion	10 October 2026
Sites	1 location across France

Conditions studied

• Neurocognitive Disorders — all drugs for Neurocognitive Disorders →

Sponsor

University Gustave Eiffel

Who can join

Adults 50 to 95, any sex, with Neurocognitive Disorders. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.