Identification of Biomarkers to Predict Driver Take-over Control Quality

NCT ID: NCT04188626

Last Updated: 2020-09-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-09
• Study Completion Date: 2020-08-06

Brief Summary

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.

Detailed 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.

Conditions

Healthy Subjects; Attention Deficit

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Driving session

The volunteers will be placed in a driving simulator that will simulate autonomous highway driving.

Group Type: EXPERIMENTAL

Driving simulator sessions

Intervention Type: BEHAVIORAL

The volunteers will be placed in a driving simulator that will simulate autonomous highway driving. This autonomous driving will be interrupted by take-over requests related to events that disrupt autonomous driving. During autonomous driving, the driver will have to disengage from driving by performing non-related driving tasks. During each non-related driving tasks, a take-over request will be sent. Electrophysiological (EEG, ECG, EDA, EMG, respiration) and behavioural data will be recorded before, during and after the take-over control.

Interventions

Driving simulator sessions

The volunteers will be placed in a driving simulator that will simulate autonomous highway driving. This autonomous driving will be interrupted by take-over requests related to events that disrupt autonomous driving. During autonomous driving, the driver will have to disengage from driving by performing non-related driving tasks. During each non-related driving tasks, a take-over request will be sent. Electrophysiological (EEG, ECG, EDA, EMG, respiration) and behavioural data will be recorded before, during and after the take-over control.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

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

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

• 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)

• 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)

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Bordeaux

OTHER

Sponsor Role: collaborator

University Hospital, Bordeaux

OTHER

Sponsor Role: collaborator

PSA Automobiles S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pierre PHILIP, MDPhD

Role: PRINCIPAL_INVESTIGATOR

Bordeaux University Hospital - Bordeaux University

Locations

Bordeaux University Hospital

Bordeaux, , France

Countries

France

Other Identifiers

ID-RCB (ANSM number)

Identifier Type: OTHER

Identifier Source: secondary_id

XP THSE BDX SNPSY

Identifier Type: -

Identifier Source: org_study_id