Randomized, Controlled, Interventional Single-Centre Study for the Design and Evaluation of an In-Vehicle Real-Time Drunk Driving Detection System - The DRIVE Test Track Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Diagnostic accuracy of the drunk driving warning system (DRIVE) to detect states of alcohol influence while driving quantified as the Area Under the Receiver Operator Characteristics Curve (AUROC)
研究概览
简要总结
To analyze driving behavior of individuals under the influence of alcohol while driving in a real car. Based on the in-vehicle variables, the investigators aim at establishing algorithms capable of discriminating sober and drunk driving using machine learning.
详细描述
Driving under the influence of alcohol (or "drunk driving") is one of the most significant causes of traffic accidents. Alcohol consumption impairs neurocognitive and psychomotor function and has been shown to be associated with an increased risk of driving accidents. However, autonomous driving (level 4 or 5) is likely to be broadly available only at a substantially later time point than previously thought due to increasing concerns of safety associated with this technology. Therefore, solutions bridging the upcoming time period by more rapidly and directly addressing the problem of drunk driving associated traffic incidents are urgently needed.
On the supposition that driving behavior differs significantly between sober state and drunk state, the investigators assume that different driving patterns of people under alcohol influence compared to sober states can be used to generate drunk driving detection models using machine learning algorithms. In this study, driving for data collection is initially performed at a sober baseline state (no alcohol) and then after alcohol administration (with a target of 0.15 mg/l and 0.35 mg/l breath alcohol concentration).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
盲法说明
The participants of the treatment group are aware of the possible induction of alcohol (purpose of the study), but blinded to the actual amount and target blood alcohol concentration. The participants of the reference group are fully informed that they do not get alcohol (open-label). The participants of the placebo group are not informed that they do not get alcohol but a placebo (blinded).
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Informed consent as documented by signature.
- •In possession of a definite Swiss or EU driving license.
- •At least 21 years old
- •Active driving in the last 6 months.
- •No special equipment needed when driving.
- •Drinks alcohol at least occasionally (moderate/social consumption).
- •Fluent in (Swiss) German and no speech impairment.
排除标准
- •Health concerns that are incompatible with alcohol consumption.
- •Any potential participant currently taking illegal drugs or medications that interact with alcohol.
- •Women who are pregnant or breast feeding.
- •Intention to become pregnant during the course of the study.
- •Teetotallers (alcohol abstinent persons).
- •Alcohol misuse (excessive alcohol consumption habits/risky drinking behaviour (according to WHO definition) and/or the biomarker PEth in capillary blood > 200 ng/mL at first visit.
- •Known or suspected drug abuse within 4 weeks before the study (e.g., positive urine drug test at first visit).
- •Non-compliance to alcohol abstinence within 24 hours before the study visits.
- •Inability to follow the procedures of the study, e.g., due to language problems, psychological disorders, dementia, etc. of the participant.
- •Participation in another study with investigational drug within the 30 days preceding and during the present study.
研究组 & 干预措施
Treatment Group
Driving under the influence of alcohol
Aware of the possible induction of alcohol (purpose of the study), but blinded to the actual amount and target blood alcohol concentration
干预措施: Driving under the influence of alcohol (Other)
Reference Group
Driving without the influence of alcohol or placebo
Fully informed
Placebo Group
Driving under the influence of a placebo
Not informed (blinded)
干预措施: Driving under the influence of a placebo (Other)
结局指标
主要结局
Diagnostic accuracy of the drunk driving warning system (DRIVE) to detect states of alcohol influence while driving quantified as the Area Under the Receiver Operator Characteristics Curve (AUROC)
时间窗: 480 minutes
The machine learning model is developed and evaluated based on in-vehicle data generated in different states of alcohol intoxication. Detection performance of alcohol influence is quantified as AUROC.
次要结局
- Number of Serious Adverse Events (SAEs)(3 months, from screening to close out visit for each participant.)
- Diagnostic accuracy of the drunk driving warning system using eye-tracking data to detect states of alcohol influence quantified as the AUROC(480 minutes)
- Diagnostic accuracy of the drunk driving warning system using physiological data to detect states of alcohol influence quantified as the Area Under the Receiver Operator Characteristics Curve (AUROC)(480 minutes)
- Diagnostic accuracy of the drunk driving warning system using controller area network data of the study car to detect states of alcohol influence quantified as the AUROC(480 minutes)
- Diagnostic accuracy of the drunk driving warning system using audio data to detect states of alcohol influence quantified as the AUROC(480 minutes)
- Diagnostic accuracy of the drunk driving warning system using gas sensor data to detect states of alcohol influence quantified as the AUROC(480 minutes)
- Diagnostic accuracy of the drunk driving warning system using radar sensor data to detect states of alcohol influence quantified as the AUROC(480 minutes)
- Change of steering over the alcohol intoxication trajectory(480 minutes)
- Change of steer torque over the alcohol intoxication trajectory(480 minutes)
- Change of steer speed over the alcohol intoxication trajectory(480 minutes)
- Change of velocity over the alcohol intoxication trajectory(480 minutes)
- Change of acceleration over the alcohol intoxication trajectory(480 minutes)
- Change of braking over the alcohol intoxication trajectory(480 minutes)
- Change of gaze acceleration over the alcohol intoxication trajectory(480 minutes)
- Change of swerving over the alcohol intoxication trajectory(480 minutes)
- Change of spinning over the alcohol intoxication trajectory(480 minutes)
- Change of gaze position over the alcohol intoxication trajectory(480 minutes)
- Change of gaze velocity over the alcohol intoxication trajectory(480 minutes)
- Change of gaze regions of interest over the alcohol intoxication trajectory(480 minutes)
- Change of gaze events over the alcohol intoxication trajectory(480 minutes)
- Change of head pose over the alcohol intoxication trajectory(480 minutes)
- Change of heart rate over the alcohol intoxication trajectory(480 minutes)
- Change of heart rate variability over the alcohol intoxication trajectory(480 minutes)
- Change of electrodermal activity over the alcohol intoxication trajectory(480 minutes)
- Change of wrist accelerometer measurements over the alcohol intoxication trajectory(480 minutes)
- Change of skin temperature over the alcohol intoxication trajectory(480 minutes)
- Self-assessment of driving performance over the alcohol intoxication trajectory(480 minutes)
- Self-estimation of alcohol concentrations over the alcohol intoxication trajectory(480 minutes)
- Number of driving mishaps over the alcohol intoxication trajectory(480 minutes)
- Number of Adverse Events (AEs)(3 months, from screening to close out visit for each participant)