Identification of Biomarkers to Predict Driver Take-over Control Quality (ANTIDOTE)

PSA Automobiles

Status

Completed

Conditions

Healthy Subjects

Attention Deficit

Treatments

Behavioral: Driving simulator sessions

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT04188626

XP THSE BDX SNPSY

ID-RCB (ANSM number) (Other Identifier)

Details and patient eligibility

About

At level 3 conditionally automated, the vehicle ensures driving and the driver disengages from driving to perform another activity independent of driving (ex: read a book, play on his phone ....). However, drivers are expected to be available to take over control for the case of system failure or limitation. This take-over control must take place in a limited time, very short, of the order of a few seconds. To take-over control of the vehicle quickly and efficiently, the driver must be, at the time of take-over, vigilant, efficient, and attentive to the environment and focused on the take-over of manual driving. Predicting the driver's reengagement capabilities to ensure that the driver will be able to take-over control of the vehicle is crucial at level 3 of autonomous driving.

The objective of ANTIDOTE is to determine physiological and behavioural parameters capable of predicting the take-over quality in level 3 conditionally automated vehicles in a simulated highway driving situation in healthy drivers or drivers with attention disorders.

Full description

At level 3 conditionally automated, the vehicle ensures driving and the driver disengages from driving to perform non-related driving tasks (ex: read a book, play on his phone ....). However, drivers are expected to be available to take over control for the case of system failure or limitation. This take-over control must take place in a limited time, very short, of the order of a few seconds. To take-over control of the vehicle quickly and efficiently, the driver must be, at the time of take-over, vigilant, efficient, and attentive to the environment and focused on the take-over of manual driving. Predicting the driver's reengagement capabilities to ensure that the driver will be able to take-over control of the vehicle is crucial at level 3 of autonomous driving.

In this context, the objective of ANTIDOTE is to determine physiological and behavioural parameters capable of predicting the take-over quality in level 3 conditionally automated vehicles in a simulated highway driving situation.

This study will examine how engagement will impact take-over control quality in 6 non-driving related secondary tasks. A driving simulator study will be conducted and data from a total of 32 healthy drivers and 16 drivers with attention disorders will be used to evaluate take-over quality.

Electrophysiological (EEG, ECG, EDA, EMG, respiration) and behavioral data will be recorded before, during and after the take-over control.

Enrollment

32 patients

Sex

All

Ages

20 to 75 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Common inclusion criteria:

male or female aged between 20 and 75 years old
BMI between 18 and 27
Subject size between 1.50 m and 1.95 m
Without sleep complains (Item of Basic Nordic Sleep Questionnaire ≤ 3)
Without excessive daytime sleepiness (Epworth score ≤ 11)
Non-professional drivers
Subjects with a driver's license for at least one year
Subjects driving at least 5000 km per year.
Having normal visual acuity (correction with lenses accepted) and normal color vision
Affiliated to a national health service
Having given written informed consent to participate in the trial.

Healthy volunteers specific inclusion criteria:

SCL90R score < 60 for anxiety and depression subscales
MMSE ≥ 30

ADHD patients specific inclusion criteria:

Patients with an ADHD disorder according to DSM 5,
Patients agreeing to discontinue psychostimulant treatment 48 hours prior to the experimental session,

Exclusion criteria

Severe life-threatening conditions in the short term,
Unstable endocrine diseases
Progressive cardiovascular diseases
Progressive neurological diseases treated or not,
Addiction to a substance
Night and shift-workers who has taken a constraints in the last 72 hours,
Psychotropic medication taking
Benzodiazepine or Z-drug medication taking
Cardiotropic medication taking
Volunteers who need glasses to drive
Having simulator-sickness during the first practice session

Healthy volunteers specific inclusion criteria:

Psychiatric co-morbidities: current major depressive episode, current hypomanic or manic episode, psychotic disorders, autism spectrum disorder
Exceeded consumption of coffee, tea or caffeinated drinks(> 5 cups / day)
Exceeded consumption of alcohol drinks (> 2 drinks / day during the last 6 months)

ADHD patients specific inclusion criteria:

Psychiatric co-morbidities: current major depressive episode, current hypomanic or manic episode, psychotic disorders, autism spectrum disorder (except ADHD)
Exceeded consumption of alcohol drinks(> 3 drinks / day during the last 6 months)