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

February 26, 2025 updated by: Taisho Pharmaceutical Co., Ltd.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 64 years (Adult)

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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)
Time Frame: 60 min.
60 min.

Secondary Outcome Measures

Outcome Measure
Time Frame
Distance Coefficient of Variation (DCV)
Time Frame: 25 min.
25 min.
Brake Reaction Time (BRT)
Time Frame: 15 min.
15 min.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taisho Pharmaceutical Co., Ltd.

Collaborators

Nagoya University

Investigators

  • Study Director: Shigeru Okuyama, Taisho Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 22, 2017

Primary Completion (Actual)

October 25, 2017

Study Completion (Actual)

October 25, 2017

Study Registration Dates

First Submitted

September 8, 2017

First Submitted That Met QC Criteria

September 8, 2017

First Posted (Actual)

September 11, 2017

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 26, 2025

Last Verified

October 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • DS-204-01
  • JapicCTI-173714 (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

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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