Design and Implementation of a Drunk Driving Detection System
DRIVE
Non-randomised, Controlled, Interventional Single-centre Study for the Design and Evaluation of an In-vehicle Drunk Driving Detection System
1 other identifier
interventional
30
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 22, 2021
CompletedFirst Posted
Study publicly available on registry
July 28, 2021
CompletedStudy Start
First participant enrolled
August 15, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 14, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 14, 2021
CompletedJanuary 3, 2022
July 1, 2021
3 months
July 22, 2021
December 30, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
480 minutes
Secondary Outcomes (35)
Change of velocity
480 minutes
Change of steer
480 minutes
Change of brake
480 minutes
Change of steer torque
480 minutes
Change of steer speed
480 minutes
- +30 more secondary outcomes
Study Arms (1)
Intervention group
EXPERIMENTALIntervention: Other: Driving under the influence of alcohol with a driving simulator
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Bernlead
- University of St.Gallencollaborator
- ETH Zurichcollaborator
Study Sites (1)
University of Bern
Bern, Switzerland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wolfgang Weinmann, Prof. Dr.
University of Bern
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 22, 2021
First Posted
July 28, 2021
Study Start
August 15, 2021
Primary Completion
November 14, 2021
Study Completion
November 14, 2021
Last Updated
January 3, 2022
Record last verified: 2021-07
Data Sharing
- IPD Sharing
- Will not share