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NCT03278080 Clinical Trial

Development of Assessment Method for Driving Ability Using Driving Simulator in Healthy Volunteers #1

Healthy Participants Clinical Trial

Official title:
Development of Assessment Method of Driving Ability Using Driving Simulator in Healthy Volunteers #1: Measurement Setup of Assessment Criteria for Driving Ability

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03278080
Other study ID # DS-204-01
Secondary ID JapicCTI-173714
Status Completed
Phase N/A
First received
Last updated
Start date September 22, 2017
Est. completion date October 25, 2017

Study information
Verified date October 2017
Source Taisho Pharmaceutical Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to set an optimal measurement time for assessing driving ability in a driving simulator in healthy volunteers.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date October 25, 2017
Est. primary completion date October 25, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 21 Years to 64 Years
Eligibility Inclusion Criteria: - Body mass index (BMI) =18.5 and <25.0 kg/m2 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 - Routinely drink alcohol before bedtime - Inappropriate for enrollment in this study was judged by principal investigator or subinvestigator

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Road-tracking test
Driving with simulator program for SDLP measurement
• Car-following test
Driving with simulator program for DCV measurement
• Harsh-braking test
Driving with simulator program for BRT measurement

Locations
Country Name City State
Japan Taisho Pharmaceutical Co., Ltd selected site Fukuoka

Sponsors (2)
Lead Sponsor Collaborator
Taisho Pharmaceutical Co., Ltd. Nagoya University

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Standard Deviation of Lateral Position (SDLP) 60 min.
Secondary Distance Coefficient of Variation (DCV) 25 min.
Secondary Brake Reaction Time (BRT) 15 min.
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