Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06320639
Status:
RECRUITING
Last Update Posted:
2024-03-20
First Post:
2024-02-19
Brief Title:
DRIVing Simulator and People With NeuroCognitive Disorders
Sponsor:
University Gustave Eiffel
Organization:
University Gustave Eiffel
Study Overview
Official Title:
Driving Simulator and People With Neurocognitive Disorders
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DRIVS-NCD
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 persons 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 drivers 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 ie 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 ie 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
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 persons 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 drivers 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 ie 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 ie 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None