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

NCT ID: NCT03278080

Last Updated: 2025-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-22

Study Completion Date

2017-10-25

Brief Summary

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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

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Conditions

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Healthy Participants

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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driving test

Group Type OTHER

Road-tracking test

Intervention Type OTHER

Driving with simulator program for SDLP measurement

Car-following test

Intervention Type OTHER

Driving with simulator program for DCV measurement

Harsh-braking test

Intervention Type OTHER

Driving with simulator program for BRT measurement

Interventions

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Road-tracking test

Driving with simulator program for SDLP measurement

Intervention Type OTHER

Car-following test

Driving with simulator program for DCV measurement

Intervention Type OTHER

Harsh-braking test

Driving with simulator program for BRT measurement

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

64 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Nagoya University

OTHER

Sponsor Role collaborator

Taisho Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shigeru Okuyama

Role: STUDY_DIRECTOR

Taisho Pharmaceutical Co., Ltd.

Locations

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Taisho Pharmaceutical Co., Ltd selected site

Fukuoka, , Japan

Site Status

Countries

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Japan

Other Identifiers

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JapicCTI-173714

Identifier Type: OTHER

Identifier Source: secondary_id

DS-204-01

Identifier Type: -

Identifier Source: org_study_id

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