Development of Assessment Method for Driving Ability Using Driving Simulator in Healthy Volunteers #2

Development of Assessment Method for Driving Ability Using Driving Simulator in Healthy Volunteers #2: Verification of Intra-individual Difference

The purpose of this study is to verify the intra-individual difference of the SDLP values in driving simulator.

Study Overview

• Status: Completed
• Conditions: Healthy Participants
• Intervention / Treatment: Other: Road-tracking test; Other: Harsh-braking test; Other: Car-following test

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Japan
  • Fukuoka, Japan
    • Taisho Pharmaceutical Co., Ltd selected site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 64 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Driving test	Other: Road-tracking test; Driving with simulator program for SDLP measurement; Other: Harsh-braking test; Driving with simulator program for BRT measurement; Other: Car-following test; Driving with simulator program for DCV measurement

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Taisho Pharmaceutical Co., Ltd.
• Collaborators: Nagoya University

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2018
• Primary Completion (Actual): April 30, 2018
• Study Completion (Actual): April 30, 2018

Study Registration Dates

• First Submitted: January 16, 2018
• First Submitted That Met QC Criteria: January 22, 2018
• First Posted (Actual): January 29, 2018

Study Record Updates

• Last Update Posted (Actual): October 6, 2022
• Last Update Submitted That Met QC Criteria: October 4, 2022
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: DS-204-02; JapicCTI-183832 (Other Identifier: JapicCTI)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No