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Completed

NCT Number: NCT03278080

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

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

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Key information

Conditions

Healthy Participants

Age range

21 year–64 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Taisho Pharmaceutical Co., Ltd selected site

Fukuoka, Japan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Road-tracking test

Other

Driving with simulator program for SDLP measurement

Car-following test

Other

Driving with simulator program for DCV measurement

Harsh-braking test

Other

Driving with simulator program for BRT measurement

Primary outcomes

  1. Standard Deviation of Lateral Position (SDLP)

    Time frame: 60 min.

Secondary outcomes

  1. Distance Coefficient of Variation (DCV)

    Time frame: 25 min.

  2. Brake Reaction Time (BRT)

    Time frame: 15 min.

Sponsors and collaborators

Lead sponsor

Taisho Pharmaceutical Co., Ltd.

Industry

Collaborators

  • Nagoya University

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Sep 11, 2017
Registry last updated
Feb 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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