跳至主要内容
临床试验/NCT04188626
NCT04188626已完成不适用

Identification of Physiological and Behavioural Biomarkers to Predict Take-over Control Quality in Level 3 Conditionally Automated Vehicles

PSA Automobiles S.A.1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2019年12月9日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
32
试验地点
1
主要终点
Quality of driving take-over behaviour

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
20 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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,

排除标准

  • •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)

研究组 & 干预措施

Driving session

Experimental

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

干预措施: Driving simulator sessions (Behavioral)

结局指标

主要结局

Quality of driving take-over behaviour

时间窗: 8 secondes after take-over request

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

次要结局

  • 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)
  • Physical activity(during the 2 minutes before the take-over request, during take-over control and the 2 minutes after the take-over control)
  • Subjective level of attention and distraction before take-over control request(8 secondes after take-over request)
  • EMG (electromyogram)(during the 2 minutes before the take-over request, during take-over control and the 2 minutes after the take-over control)
  • Eye tracking(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)
  • Respiration(during the 2 minutes before the take-over request, during take-over control and the 2 minutes after the take-over control)
  • Subjective driving take-over control quality: Visual analogic scale(8 secondes after take-over request)
  • 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)

研究者

发起方
PSA Automobiles S.A.
申办方类型
Industry
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

Identification of Biomarkers to Predict Driver... | 临床试验