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

Sponsor
Taisho Pharmaceutical Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT03413592
Collaborator
Nagoya University (Other)
20
1
1
3.2
6.2

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: Road-tracking test
  • Other: Car-following test
  • Other: Harsh-braking test
N/A

Study Design

Study Type:
Interventional
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 for Driving Ability Using Driving Simulator in Healthy Volunteers #2: Verification of Intra-individual Difference
Actual Study Start Date :
Jan 22, 2018
Actual Primary Completion Date :
Apr 30, 2018
Actual Study Completion Date :
Apr 30, 2018

Arms and Interventions

Arm Intervention/Treatment
Other: 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

Outcome Measures

Primary Outcome Measures

  1. Standard Deviation of Lateral Position (SDLP) [60 min]

Secondary Outcome Measures

  1. Distance Coefficient of Variation (DCV) [5 min]

  2. Brake Reaction Time (BRT) [5 min]

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 64 Years
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Taisho Pharmaceutical Co., Ltd selected site Fukuoka Japan

Sponsors and Collaborators

  • Taisho Pharmaceutical Co., Ltd.
  • Nagoya University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Taisho Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT03413592
Other Study ID Numbers:
  • DS-204-02
  • JapicCTI-183832
First Posted:
Jan 29, 2018
Last Update Posted:
Jul 6, 2018
Last Verified:
Jul 1, 2018
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jul 6, 2018