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

Not Applicable

Completed

• Conditions: Healthy Participants
• Interventions: Other: Road-tracking test; Other: Car-following test; Other: Harsh-braking test

• Registration Number: NCT03278080
• Lead Sponsor: Taisho Pharmaceutical Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-09-08
• Study First Submitted QC: 2017-09-08
• Study First Posted: 2017-09-11
• Study Start: 2017-09-22
• Status Verified: 2017-10
• Primary Completion: 2017-10-25
• Study Completion: 2017-10-25
• Last Update Submitted: 2025-02-26
• Last Update Posted: 2025-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
driving test	Car-following test	-
driving test	Road-tracking test	-
driving test	Harsh-braking test	-

Primary Outcome Measures

Name	Time	Method
Standard Deviation of Lateral Position (SDLP)	60 min.

Secondary Outcome Measures

Name	Time	Method
Distance Coefficient of Variation (DCV)	25 min.
Brake Reaction Time (BRT)	15 min.

Trial Locations

Locations (1)

Taisho Pharmaceutical Co., Ltd selected site; 🇯🇵 Fukuoka, Japan