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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03278080
Recruitment Status : Completed
First Posted : September 11, 2017
Last Update Posted : January 17, 2018
Nagoya University
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Healthy Participants Other: Road-tracking test Other: Car-following test Other: Harsh-braking test Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Development of Assessment Method of Driving Ability Using Driving Simulator in Healthy Volunteers #1: Measurement Setup of Assessment Criteria for Driving Ability
Actual Study Start Date : September 22, 2017
Actual Primary Completion Date : October 25, 2017
Actual Study Completion Date : October 25, 2017

Arm Intervention/treatment
driving test Other: Road-tracking test
Driving with simulator program for SDLP measurement

Other: Car-following test
Driving with simulator program for DCV measurement

Other: Harsh-braking test
Driving with simulator program for BRT measurement

Primary Outcome Measures :
  1. Standard Deviation of Lateral Position (SDLP) [ Time Frame: 60 min. ]

Secondary Outcome Measures :
  1. Distance Coefficient of Variation (DCV) [ Time Frame: 25 min. ]
  2. Brake Reaction Time (BRT) [ Time Frame: 15 min. ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   21 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03278080

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Taisho Pharmaceutical Co., Ltd selected site
Fukuoka, Japan
Sponsors and Collaborators
Taisho Pharmaceutical Co., Ltd.
Nagoya University
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Study Director: Shigeru Okuyama Taisho Pharmaceutical Co., Ltd.
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Responsible Party: Taisho Pharmaceutical Co., Ltd. Identifier: NCT03278080    
Other Study ID Numbers: DS-204-01
JapicCTI-173714 ( Other Identifier: JapicCTI )
First Posted: September 11, 2017    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: October 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No