Identification of Biomarkers to Predict Driver Take-over Control Quality

NCT04188626 | Completed

• 2 other identifiers: XP THSE BDX SNPSYID-RCB (ANSM number)
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Subjects; Attention Deficit

Keywords

Automated driving; Conditional automation; Driver distraction; Driver take-over quality; Biomarkers

Outcome Measures

Primary Outcomes (1)

• Quality of driving take-over behaviour

  Quality of driving take-over behaviour (Good/bad) will be assessed by collision (collision or driving off the road) and critical encounters (Time To Collision). Time to collision (TTC) refers to the time required for the vehicle to collide with the stationary obstacle obstructing the driving lane if it continues at its speed at the time it changes to the next lane completely. Good : no collision AND TTC \>= 1.5 secondes Bad : collision or no collision AND TTC \< 1.5 secondes

  8 secondes after take-over request

Secondary Outcomes (10)

• EEG (electroencephalogram)

  during the 2 minutes before the take-over request, during take-over control and the 2 minutes after the take-over control

• ECG (electrocardiogram)

  during the 2 minutes before the take-over request, during take-over control and the 2 minutes after the take-over control

• EMG (electromyogram)

  during the 2 minutes before the take-over request, during take-over control and the 2 minutes after the take-over control

• Electrodermal activity 1 (EDA)

  during the 2 minutes before the take-over request, during take-over control and the 2 minutes after the take-over control

• Electrodermal activity 2 (EDA)

  during the 2 minutes before the take-over request, during take-over control and the 2 minutes after the take-over control

Study Arms (1)

Driving session

EXPERIMENTAL

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

Behavioral: Driving simulator sessions

Interventions

Driving simulator sessions 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.

Driving session

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• PSA Automobiles S.A.: lead
• University of Bordeaux: collaborator
• University Hospital, Bordeaux: collaborator

Study Sites (1)

Bordeaux University Hospital

Bordeaux, 33000, France

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Pierre PHILIP, MDPhD

  Bordeaux University Hospital - Bordeaux University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Monocentric preliminary study including an experimental driving session in a driving simulator.

Study Record Dates

• First Submitted: November 18, 2019
• First Posted: December 6, 2019
• Study Start: December 9, 2019
• Primary Completion: August 6, 2020
• Study Completion: August 6, 2020
• Last Updated: September 21, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)