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

NCT03278080 — Not applicable, Completed, 20 participants, Taisho Pharmaceutical Co., Ltd.

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

RegistryNCT03278080
StatusCompleted
PhaseNot applicable
Study typeInterventional; na, single group, masking: none, other
Enrollment20 (Actual)
SponsorTaisho Pharmaceutical Co., Ltd. (Industry); collaborators: Nagoya University
ConditionsHealthy Participants
InterventionsRoad-tracking test, Car-following test, Harsh-braking test (Other)
Datesstart 2017-09-22, primary completion 2017-10-25, completion 2017-10-25, first posted 2017-09-11, last updated 2025-02-28
Locations1 site in Japan

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-Summary

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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+Arms and interventions

ArmTypeInterventionsDescription
driving testOtherOther: Road-tracking test; Other: Car-following test; Other: Harsh-braking test
  • 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

+Outcome measures

Primary outcomes

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

Secondary outcomes

  • Distance Coefficient of Variation (DCV) [25 min.]
  • Brake Reaction Time (BRT) [15 min.]

+Eligibility

Sex: Male, ages: 21 Years to 64 Years, accepts healthy volunteers

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

+Locations (1)

FacilityCityCountryStatus
Taisho Pharmaceutical Co., Ltd selected siteFukuokaJapan

+Investigators

My Notes