Development of Assessment Method for Driving Ability Using Driving Simulator in Healthy Volunteers #3
Status
Completed
Conditions
Healthy Participants
Treatments
Other: Harsh-braking test
Other: Car-following test
Other: Road-tracking test
Study type
Interventional
Funder types
Other
Industry
Identifiers
Details and patient eligibility
About
The purpose of this study is to collect alcohol calibration data for the driving simulator.
Enrollment
25 patients
Sex
Male
Ages
21 to 64 years old
Volunteers
Accepts Healthy Volunteers
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
Trial design
Primary purpose
Other
Allocation
Randomized
Interventional model
Crossover Assignment
Masking
Quadruple Blind
25 participants in 4 patient groups
Blood alcohol concentration (BAC) level 0.025 %
Other group
Description:
Drink beverages containing alcohol calculated to have a blood alcohol concentration of 0.025%
Treatment:
Other: Road-tracking test
Other: Harsh-braking test
Other: Car-following test
BAC level 0.05 %
Other group
Description:
Drink beverages containing alcohol calculated to have a blood alcohol concentration of 0.05%
Treatment:
Other: Road-tracking test
Other: Harsh-braking test
Other: Car-following test
BAC level 0.09 %
Other group
Description:
Drink beverages containing alcohol calculated to have a blood alcohol concentration of 0.09%
Treatment:
Other: Road-tracking test
Other: Harsh-braking test
Other: Car-following test
BAC level 0 %
Other group
Description:
Drink beverages containing non alcohol
Treatment:
Other: Road-tracking test
Other: Harsh-braking test
Other: Car-following test
Trial contacts and locations
1
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