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

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

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

Conditions
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Healthy Participants

Intervention / Treatment
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* Other: Road-tracking test
* Other: Car-following test
* Other: Harsh-braking test


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Blood alcohol concentration (BAC) level 0.025 %<br>Drink beverages containing alcohol calculated to have a blood alcohol concentration of 0.025% | Other: Road-tracking test<br>* Driving with simulator program for SDLP measurement<br>Other: Car-following test<br>* Driving with simulator program for DCV measurement<br>Other: Harsh-braking test<br>* Driving with simulator program for BRT measurement<br>|
| Other: BAC level 0.05 %<br>Drink beverages containing alcohol calculated to have a blood alcohol concentration of 0.05% | Other: Road-tracking test<br>* Driving with simulator program for SDLP measurement<br>Other: Car-following test<br>* Driving with simulator program for DCV measurement<br>Other: Harsh-braking test<br>* Driving with simulator program for BRT measurement<br>|
| Other: BAC level 0.09 %<br>Drink beverages containing alcohol calculated to have a blood alcohol concentration of 0.09% | Other: Road-tracking test<br>* Driving with simulator program for SDLP measurement<br>Other: Car-following test<br>* Driving with simulator program for DCV measurement<br>Other: Harsh-braking test<br>* Driving with simulator program for BRT measurement<br>|
| Other: BAC level 0 %<br>Drink beverages containing non alcohol | Other: Road-tracking test<br>* Driving with simulator program for SDLP measurement<br>Other: Car-following test<br>* Driving with simulator program for DCV measurement<br>Other: Harsh-braking test<br>* Driving with simulator program for BRT measurement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Standard Deviation of Lateral Position (SDLP) |  | 60 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distance Coefficient of Variation (DCV) |  | 5 min | 
| Brake Reaction Time (BRT) |  | 5 min |