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Development of Assessment Method for Driving Ability Using Driving Simulator in Healthy Volunteers #3

Development of Assessment Method for Driving Ability Using Driving Simulator in Healthy Volunteers #3: Alcohol Calibration

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03572985
Enrollment
25
Registered
2018-06-28
Start date
2018-06-27
Completion date
2019-01-31
Last updated
2025-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Participants

Brief summary

The purpose of this study is to collect alcohol calibration data for the driving simulator.

Interventions

Driving with simulator program for SDLP measurement

Driving with simulator program for DCV measurement

Driving with simulator program for BRT measurement

Sponsors

Nagoya University
CollaboratorOTHER
Taisho Pharmaceutical Co., Ltd.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
21 Years to 64 Years
Healthy volunteers
Yes

Inclusion criteria

* Body mass index (BMI) ≥18.5 and \<25.0 kg/m\^2 at screening inspection * No visual impairment (enable to correct the vision with eyeglasses or contact lens) * Receive a prior explanation on the study, able to accept its content, and capable to provide voluntary written consent for participation in this study

Exclusion criteria

* History of drug and food allergy * Alcohol dependence, drug dependence or abnormal drunken (including past history) * Inappropriate for enrollment in this study was judged by principal investigator or subinvestigator

Design outcomes

Primary

MeasureTime frame
Standard Deviation of Lateral Position (SDLP)60 min

Secondary

MeasureTime frame
Distance Coefficient of Variation (DCV)5 min
Brake Reaction Time (BRT)5 min

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026