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Design and Implementation of a Drunk Driving Detection System (DRIVE)

Primary Purpose

Transportation Accidents, Drunk Driving, Alcohol Drinking

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Driving under the influence of alcohol with a driving simulator
Sponsored by
University of Bern
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Transportation Accidents focused on measuring Metabolism, Machine Learning, Automotive Technology, Driving, Driving Simulator, Alcohol biomarker, Cortisol, Phosphatidylethanol

Eligibility Criteria

17 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Informed consent as documented by signature.
  • In possession of a Swiss or EU driving license for at least two years.
  • At least driving 1'000 kilometers per year.
  • No special equipment needed when driving.
  • Drinks alcohol at least occasionally (moderate/social consumption).
  • Fluent in (Swiss) German and no speech impairment.
  • Lives in or near Bern.

Exclusion Criteria:

  • 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 PEth in capillary blood > 210 ng/mL at first visit.
  • Known or suspected non-compliance or drug abuse.
  • 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.

Sites / Locations

  • University of Bern

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention group

Arm Description

Intervention: Other: Driving under the influence of alcohol with a driving simulator

Outcomes

Primary Outcome Measures

Accuracy of the DRIVE-model: Diagnostic accuracy of the drunk driving warning system (DRIVE) to detect drunk driving (>= 0.25 mg/l breath alcohol concentration (BrAC)) quantified as the area under the receiver operator characteristics curve (AUC ROC).
Accuracy of the DRIVE-model will be assessed using driving data recorded in sober and drunk driving states and driving data will be analysed using applied machine learning technology for impaired driving detection.

Secondary Outcome Measures

Change of velocity
Change of velocity between drunk driving above the legal limit (>= 0.25 mg/l BrAC), driving within the legal limit (<0.25 mg/l BrAC) and sober driving.
Change of steer
Change of steer between drunk driving above the legal limit (>= 0.25 mg/l BrAC), driving within the legal limit (<0.25 mg/l BrAC) and sober driving.
Change of brake
Change of brake between drunk driving above the legal limit (>= 0.25 mg/l BrAC), driving within the legal limit (<0.25 mg/l BrAC) and sober driving.
Change of steer torque
Change of steer torque between drunk driving above the legal limit (>= 0.25 mg/l BrAC), driving within the legal limit (<0.25 mg/l BrAC) and sober driving.
Change of steer speed
Change of steer speed between drunk driving above the legal limit (>= 0.25 mg/l BrAC), driving within the legal limit (<0.25 mg/l BrAC) and sober driving.
Change of time driving over midline
Change of time over midline between drunk driving above the legal limit (>= 0.25 mg/l BrAC), driving within the legal limit (<0.25 mg/l BrAC) and sober driving.
Change of swerving
Change of swerving between drunk driving above the legal limit (>= 0.25 mg/l BrAC), driving within the legal limit (<0.25 mg/l BrAC) and sober driving.
Change of spinning
Change of spinning between drunk driving above the legal limit (>= 0.25 mg/l BrAC), driving within the legal limit (<0.25 mg/l BrAC) and sober driving.
Change of gaze behavior
Change of gaze behavior (as gaze velocity, acceleration or direction changes) between drunk driving above the legal limit (>= 0.25 mg/l BrAC), driving within the legal limit (<0.25 mg/l BrAC) and sober driving.
Change of gaze regions of interest
Change of gaze regions of interest (as amount and duration of speedometer or front shield inspections) between drunk driving above the legal limit (>= 0.25 mg/l BrAC), driving within the legal limit (<0.25 mg/l BrAC) and sober driving.
Change of gaze events
Change of gaze events (as amount and duration of fixations or saccades) between drunk driving above the legal limit (>= 0.25 mg/l BrAC), driving within the legal limit (<0.25 mg/l BrAC) and sober driving.
Defining the alcohol concentration when driving performance is decreased
Breath alcohol concentration (mg/l BrAC) when driving performance begins to be impaired will be assessed based on significantly altered driving parameters for drunk driving above the legal limit (>= 0.25 mg/l BrAC), below the legal limit (<0.25 mg/l BAC) and sober driving.
Driving performance while being sober, above and within the legal limit
Based on significantly altered driving parameters above the legal limit of drunk driving (>= 0.25 mg/l breath alcohol concentration in Switzerland) driving performance while being sober, above and within the legal limit will be assessed.
Change of heart-rate
Change of heart-rate between drunk driving above the legal limit (>= 0.25 mg/l BrAC), driving within the legal limit (<0.25 mg/l BrAC) and sober driving.
Change of heart-rate variability
Change of heart-rate variability between drunk driving above the legal limit (>= 0.25 mg/l BrAC), driving within the legal limit (<0.25 mg/l BrAC) and sober driving.
Change of wrist accelerometer
Change of wrist accelerometer recorded by a wearable between drunk driving above the legal limit (>= 0.25 mg/l BrAC), driving within the legal limit (<0.25 mg/l BrAC) and sober driving.
Change of electrodermal activity (EDA)
Change of EDA between drunk driving above the legal limit (>= 0.25 mg/l BrAC), driving within the legal limit (<0.25 mg/l BrAC) and sober driving.
Change of skin temperature
Change of skin temperature between drunk driving above the legal limit (>= 0.25 mg/l BrAC), driving within the legal limit (<0.25 mg/l BrAC) and sober driving.
Change of oral fluid cortisol
Change of oral fluid cortisol between before the study day, before driving, during driving in sober state, above the legal limit (>= 0.25 mg/l BrAC), and under the legal limit (< 0.25 mg/l BrAC) will be assessed.
Change of phosphatidylethanol (PEth) in capillary blood
Change of phosphatidylethanol in capillary blood between before the study day, before driving, during driving in sober state, above the legal limit (>= 0.25 mg/l BrAC), and under the legal limit (< 0.25 mg/l BrAC) will be assessed.
Change of ethylglucuronide (EtG) in capillary blood
Change of ethylglucuronide in capillary blood between before the study day, before driving, during driving in sober state, above the legal limit (>= 0.25 mg/l BrAC), and under the legal limit (< 0.25 mg/l BrAC) will be assessed.
Change of ethylsulfate (EtS) in capillary blood
Change of ethylsulfate in capillary blood between before the study day, before driving, during driving in sober state, above the legal limit (>= 0.25 mg/l BrAC), and under the legal limit (< 0.25 mg/l BrAC) will be assessed.
Change of cortisol in capillary blood
Change of cortisol in capillary blood between before the study day, before driving, during driving in sober state, above the legal limit (>= 0.25 mg/l BrAC), and under the legal limit (< 0.25 mg/l BrAC) will be assessed.
Accuracy-comparison of DRIVE-model and DRIVEplus-model
Diagnostic accuracy of the drunk driving warning system (DRIVING) to detect drunk driving (>= 0.25 mg/l BrAC) quantified as the area under the receiver operator characteristics curve (AUC ROC) using only driving parameters (DRIVE-model) will be compared to the DRIVE-model with additional integration of physiological parameters (heart-rate, heart-rate variability, electrodermal activity (EDA), skin temperature, accelerometer, facial expression, gaze behavior, and radar) (DRIVEplus-model)
Diagnostic accuracy in detecting drunk driving (>= 0.25 mg/l BrAC) quantified as the area under the receiver operator characteristics curve using physiological data
Accuracy of drunk driving detection using physiological data (heart-rate, heart-rate variability, skin temperature, EDA, accelerometer) recorded with wearable devices during the study period will be analysed using applied machine learning technology.
Diagnostic accuracy in detecting drunk driving (>= 0.25 mg/l BrAC) quantified as the area under the receiver operator curve (AUC-ROC) using video data
Using video data recorded by a camera and a thermal camera accuracy in drunk driving detection will be analysed with applied machine learning technology.
Diagnostic accuracy in detecting drunk driving (>= 0.25 mg/l BrAC) quantified as the area under the receiver operator curve (AUC-ROC) using eye-tracking data
Using eye-tracking data recorded by a camera and an eye-tracker (to record gaze behaviour) accuracy in drunk driving detection will be analysed with applied machine learning technology.
Diagnostic accuracy in detecting drunk driving (>= 0.25 mg/l BrAC) quantified as the area under the receiver operator curve (AUC-ROC) using audio data
Using audio data recorded by microphones accuracy in drunk driving detection will be analysed with applied machine learning technology.
Diagnostic accuracy in detecting drunk driving (>= 0.25 mg/l BrAC) quantified as the area under the receiver operator curve (AUC-ROC) using radar sensor data
Using radar sensor data (directed on the body of the driver) accuracy in drunk driving detection will be analysed with applied machine learning technology.
Self-estimation of alcohol concentrations
Correlation between self-estimated alcohol concentrations and measured breath alcohol concentrations will be assessed.
Self-estimation of driving performance
Correlation between self-estimated driving performance and measured driving performance based on significantly altered driving parameters in sober state, above the legal limit (>= 0.25 mg/l BrAC), and under the legal limit (< 0.25 mg/l BrAC) will be assessed. Driving performance will be assessed with two questionnaires. Driving performance will be assessed with on an absolute 5-point scale from 0-5 (a higher value means higher driving performance).
Self-estimation of workload
Correlation between self-estimated workload and measured driving performance based on significantly altered driving parameters in sober state, above the legal limit (>= 0.25 mg/l BrAC), and under the legal limit (< 0.25 mg/l BrAC) will be assessed. Workload will be assessed an absolute 20-point scale from 0-20 (a higher value means higher workload).
Self-estimation of sleepiness levels
Correlation between self-estimated sleepiness levels, measured driving performance, and measured breath alcohol concentrations based on significantly altered driving parameters in sober state, above the legal limit (>= 0.25 mg/l BrAC), and under the legal limit (< 0.25 mg/l BrAC) will be assessed. Sleepiness will be assessed on an absolute 7-point scale from 0-6 (a lower value means less sleepiness).
Incidence of Adverse Events (AEs)
Adverse Events will be recorded at each study visit.
Incidence of Serious Adverse Events (SAEs)
Serious Adverse Events will be recorded at each study visit.

Full Information

First Posted
July 22, 2021
Last Updated
December 30, 2021
Sponsor
University of Bern
Collaborators
University of St.Gallen, ETH Zurich
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1. Study Identification

Unique Protocol Identification Number
NCT04980846
Brief Title
Design and Implementation of a Drunk Driving Detection System
Acronym
DRIVE
Official Title
Non-randomised, Controlled, Interventional Single-centre Study for the Design and Evaluation of an In-vehicle Drunk Driving Detection System
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
August 15, 2021 (Actual)
Primary Completion Date
November 14, 2021 (Actual)
Study Completion Date
November 14, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Bern
Collaborators
University of St.Gallen, ETH Zurich

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
To analyse driving behavior of individuals under the influence of alcohol using a validated research driving simulator. Based on the driving variables provided by the simulator the investigators aim at establishing algorithms capable of discriminating sober and drunk driving patterns using machine learning neural networks (deep machine learning classifiers).
Detailed Description
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. Automotive technology is highly dynamic, and fully autonomous driving might, in the end, resolve the issue of alcohol impaired accidents. However, autonomous driving (level 4 or 5) is likely to be broadly available only to a substantially later time point than previously thought due to increasing concerns of safety associated with this technology. Therefore, solutions bridging the upcoming period by more rapidly and directly addressing the problem of drunk driving-associated traffic incidents are urgently needed. On the supposition that driving behaviour differs significantly between sober and drunk states, the investigators assume that different driving patterns in both states can be used to generate drunk driving detection models using machine learning neural networks (deep machine learning classifiers).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Transportation Accidents, Drunk Driving, Alcohol Drinking, Impaired Driving
Keywords
Metabolism, Machine Learning, Automotive Technology, Driving, Driving Simulator, Alcohol biomarker, Cortisol, Phosphatidylethanol

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Intervention: Other: Driving under the influence of alcohol with a driving simulator
Intervention Type
Other
Intervention Name(s)
Driving under the influence of alcohol with a driving simulator
Intervention Description
Participants will drive in three different states (sober, drunk above and below the legal limit) on designated circuits using a driving simulator. After the initial sober driving session, participants are administered pre-mixed alcoholic beverages (e.g., vodka orange). Participants are expected to achieve a target BrAC of 0.35 mg/l (legal limit in Switzerland is 0.25 mg/l BrAC) before the second driving session starts. Finally, the third driving session starts when the participants' BrAC drops to 0.15 mg/l. Heart rate, skin conductance, accelerometer, eye movement, radar, facial expression, and speech will be recorded by a smart-watch, an eye-tracker, microphones and an onboard camera, respectively. Participants will be blinded to their alcohol levels during the study. They will have to rate their symptoms and their performance via questionnaires before and after each driving session. Further, capillary blood and oral fluid samples will be collected.
Primary Outcome Measure Information:
Title
Accuracy of the DRIVE-model: Diagnostic accuracy of the drunk driving warning system (DRIVE) to detect drunk driving (>= 0.25 mg/l breath alcohol concentration (BrAC)) quantified as the area under the receiver operator characteristics curve (AUC ROC).
Description
Accuracy of the DRIVE-model will be assessed using driving data recorded in sober and drunk driving states and driving data will be analysed using applied machine learning technology for impaired driving detection.
Time Frame
480 minutes
Secondary Outcome Measure Information:
Title
Change of velocity
Description
Change of velocity between drunk driving above the legal limit (>= 0.25 mg/l BrAC), driving within the legal limit (<0.25 mg/l BrAC) and sober driving.
Time Frame
480 minutes
Title
Change of steer
Description
Change of steer between drunk driving above the legal limit (>= 0.25 mg/l BrAC), driving within the legal limit (<0.25 mg/l BrAC) and sober driving.
Time Frame
480 minutes
Title
Change of brake
Description
Change of brake between drunk driving above the legal limit (>= 0.25 mg/l BrAC), driving within the legal limit (<0.25 mg/l BrAC) and sober driving.
Time Frame
480 minutes
Title
Change of steer torque
Description
Change of steer torque between drunk driving above the legal limit (>= 0.25 mg/l BrAC), driving within the legal limit (<0.25 mg/l BrAC) and sober driving.
Time Frame
480 minutes
Title
Change of steer speed
Description
Change of steer speed between drunk driving above the legal limit (>= 0.25 mg/l BrAC), driving within the legal limit (<0.25 mg/l BrAC) and sober driving.
Time Frame
480 minutes
Title
Change of time driving over midline
Description
Change of time over midline between drunk driving above the legal limit (>= 0.25 mg/l BrAC), driving within the legal limit (<0.25 mg/l BrAC) and sober driving.
Time Frame
480 minutes
Title
Change of swerving
Description
Change of swerving between drunk driving above the legal limit (>= 0.25 mg/l BrAC), driving within the legal limit (<0.25 mg/l BrAC) and sober driving.
Time Frame
480 minutes
Title
Change of spinning
Description
Change of spinning between drunk driving above the legal limit (>= 0.25 mg/l BrAC), driving within the legal limit (<0.25 mg/l BrAC) and sober driving.
Time Frame
480 minutes
Title
Change of gaze behavior
Description
Change of gaze behavior (as gaze velocity, acceleration or direction changes) between drunk driving above the legal limit (>= 0.25 mg/l BrAC), driving within the legal limit (<0.25 mg/l BrAC) and sober driving.
Time Frame
480 minutes
Title
Change of gaze regions of interest
Description
Change of gaze regions of interest (as amount and duration of speedometer or front shield inspections) between drunk driving above the legal limit (>= 0.25 mg/l BrAC), driving within the legal limit (<0.25 mg/l BrAC) and sober driving.
Time Frame
480 minutes
Title
Change of gaze events
Description
Change of gaze events (as amount and duration of fixations or saccades) between drunk driving above the legal limit (>= 0.25 mg/l BrAC), driving within the legal limit (<0.25 mg/l BrAC) and sober driving.
Time Frame
480 minutes
Title
Defining the alcohol concentration when driving performance is decreased
Description
Breath alcohol concentration (mg/l BrAC) when driving performance begins to be impaired will be assessed based on significantly altered driving parameters for drunk driving above the legal limit (>= 0.25 mg/l BrAC), below the legal limit (<0.25 mg/l BAC) and sober driving.
Time Frame
480 minutes
Title
Driving performance while being sober, above and within the legal limit
Description
Based on significantly altered driving parameters above the legal limit of drunk driving (>= 0.25 mg/l breath alcohol concentration in Switzerland) driving performance while being sober, above and within the legal limit will be assessed.
Time Frame
480 minutes
Title
Change of heart-rate
Description
Change of heart-rate between drunk driving above the legal limit (>= 0.25 mg/l BrAC), driving within the legal limit (<0.25 mg/l BrAC) and sober driving.
Time Frame
480 minutes
Title
Change of heart-rate variability
Description
Change of heart-rate variability between drunk driving above the legal limit (>= 0.25 mg/l BrAC), driving within the legal limit (<0.25 mg/l BrAC) and sober driving.
Time Frame
480 minutes
Title
Change of wrist accelerometer
Description
Change of wrist accelerometer recorded by a wearable between drunk driving above the legal limit (>= 0.25 mg/l BrAC), driving within the legal limit (<0.25 mg/l BrAC) and sober driving.
Time Frame
480 minutes
Title
Change of electrodermal activity (EDA)
Description
Change of EDA between drunk driving above the legal limit (>= 0.25 mg/l BrAC), driving within the legal limit (<0.25 mg/l BrAC) and sober driving.
Time Frame
480 minutes
Title
Change of skin temperature
Description
Change of skin temperature between drunk driving above the legal limit (>= 0.25 mg/l BrAC), driving within the legal limit (<0.25 mg/l BrAC) and sober driving.
Time Frame
480 minutes
Title
Change of oral fluid cortisol
Description
Change of oral fluid cortisol between before the study day, before driving, during driving in sober state, above the legal limit (>= 0.25 mg/l BrAC), and under the legal limit (< 0.25 mg/l BrAC) will be assessed.
Time Frame
2 weeks
Title
Change of phosphatidylethanol (PEth) in capillary blood
Description
Change of phosphatidylethanol in capillary blood between before the study day, before driving, during driving in sober state, above the legal limit (>= 0.25 mg/l BrAC), and under the legal limit (< 0.25 mg/l BrAC) will be assessed.
Time Frame
2 weeks
Title
Change of ethylglucuronide (EtG) in capillary blood
Description
Change of ethylglucuronide in capillary blood between before the study day, before driving, during driving in sober state, above the legal limit (>= 0.25 mg/l BrAC), and under the legal limit (< 0.25 mg/l BrAC) will be assessed.
Time Frame
2 weeks
Title
Change of ethylsulfate (EtS) in capillary blood
Description
Change of ethylsulfate in capillary blood between before the study day, before driving, during driving in sober state, above the legal limit (>= 0.25 mg/l BrAC), and under the legal limit (< 0.25 mg/l BrAC) will be assessed.
Time Frame
2 weeks
Title
Change of cortisol in capillary blood
Description
Change of cortisol in capillary blood between before the study day, before driving, during driving in sober state, above the legal limit (>= 0.25 mg/l BrAC), and under the legal limit (< 0.25 mg/l BrAC) will be assessed.
Time Frame
2 weeks
Title
Accuracy-comparison of DRIVE-model and DRIVEplus-model
Description
Diagnostic accuracy of the drunk driving warning system (DRIVING) to detect drunk driving (>= 0.25 mg/l BrAC) quantified as the area under the receiver operator characteristics curve (AUC ROC) using only driving parameters (DRIVE-model) will be compared to the DRIVE-model with additional integration of physiological parameters (heart-rate, heart-rate variability, electrodermal activity (EDA), skin temperature, accelerometer, facial expression, gaze behavior, and radar) (DRIVEplus-model)
Time Frame
480 minutes
Title
Diagnostic accuracy in detecting drunk driving (>= 0.25 mg/l BrAC) quantified as the area under the receiver operator characteristics curve using physiological data
Description
Accuracy of drunk driving detection using physiological data (heart-rate, heart-rate variability, skin temperature, EDA, accelerometer) recorded with wearable devices during the study period will be analysed using applied machine learning technology.
Time Frame
480 minutes
Title
Diagnostic accuracy in detecting drunk driving (>= 0.25 mg/l BrAC) quantified as the area under the receiver operator curve (AUC-ROC) using video data
Description
Using video data recorded by a camera and a thermal camera accuracy in drunk driving detection will be analysed with applied machine learning technology.
Time Frame
480 minutes
Title
Diagnostic accuracy in detecting drunk driving (>= 0.25 mg/l BrAC) quantified as the area under the receiver operator curve (AUC-ROC) using eye-tracking data
Description
Using eye-tracking data recorded by a camera and an eye-tracker (to record gaze behaviour) accuracy in drunk driving detection will be analysed with applied machine learning technology.
Time Frame
480 minutes
Title
Diagnostic accuracy in detecting drunk driving (>= 0.25 mg/l BrAC) quantified as the area under the receiver operator curve (AUC-ROC) using audio data
Description
Using audio data recorded by microphones accuracy in drunk driving detection will be analysed with applied machine learning technology.
Time Frame
480 minutes
Title
Diagnostic accuracy in detecting drunk driving (>= 0.25 mg/l BrAC) quantified as the area under the receiver operator curve (AUC-ROC) using radar sensor data
Description
Using radar sensor data (directed on the body of the driver) accuracy in drunk driving detection will be analysed with applied machine learning technology.
Time Frame
480 minutes
Title
Self-estimation of alcohol concentrations
Description
Correlation between self-estimated alcohol concentrations and measured breath alcohol concentrations will be assessed.
Time Frame
480 minutes
Title
Self-estimation of driving performance
Description
Correlation between self-estimated driving performance and measured driving performance based on significantly altered driving parameters in sober state, above the legal limit (>= 0.25 mg/l BrAC), and under the legal limit (< 0.25 mg/l BrAC) will be assessed. Driving performance will be assessed with two questionnaires. Driving performance will be assessed with on an absolute 5-point scale from 0-5 (a higher value means higher driving performance).
Time Frame
480 minutes
Title
Self-estimation of workload
Description
Correlation between self-estimated workload and measured driving performance based on significantly altered driving parameters in sober state, above the legal limit (>= 0.25 mg/l BrAC), and under the legal limit (< 0.25 mg/l BrAC) will be assessed. Workload will be assessed an absolute 20-point scale from 0-20 (a higher value means higher workload).
Time Frame
480 minutes
Title
Self-estimation of sleepiness levels
Description
Correlation between self-estimated sleepiness levels, measured driving performance, and measured breath alcohol concentrations based on significantly altered driving parameters in sober state, above the legal limit (>= 0.25 mg/l BrAC), and under the legal limit (< 0.25 mg/l BrAC) will be assessed. Sleepiness will be assessed on an absolute 7-point scale from 0-6 (a lower value means less sleepiness).
Time Frame
480 minutes
Title
Incidence of Adverse Events (AEs)
Description
Adverse Events will be recorded at each study visit.
Time Frame
3 weeks
Title
Incidence of Serious Adverse Events (SAEs)
Description
Serious Adverse Events will be recorded at each study visit.
Time Frame
3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Informed consent as documented by signature. In possession of a Swiss or EU driving license for at least two years. At least driving 1'000 kilometers per year. No special equipment needed when driving. Drinks alcohol at least occasionally (moderate/social consumption). Fluent in (Swiss) German and no speech impairment. Lives in or near Bern. Exclusion Criteria: 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 PEth in capillary blood > 210 ng/mL at first visit. Known or suspected non-compliance or drug abuse. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wolfgang Weinmann, Prof. Dr.
Organizational Affiliation
University of Bern
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Bern
City
Bern
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No

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Design and Implementation of a Drunk Driving Detection System

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