Design and Evaluation of an In-Vehicle Real-Time Drunk Driving Detection System (DRIVE)

University of Bern

Status: Completed

Conditions: Impaired Driving; Drunk Driving; Alcohol Drinking

Treatments: Other: Driving under the influence of alcohol; Other: Driving under the influence of a placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05796609

DRIVE Test Track

SNCTP000005396 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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. 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).

Enrollment: 55 patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

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 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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55 participants in 3 patient groups, including a placebo group

Treatment Group

Experimental group

Description:

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

Treatment:

Other: Driving under the influence of alcohol

Reference Group

No Intervention group

Description:

Driving without the influence of alcohol or placebo Fully informed

Placebo Group

Placebo Comparator group

Description:

Driving under the influence of a placebo Not informed (blinded)

Treatment:

Other: Driving under the influence of a placebo