臨床研究等提出・公開システム

Scientific Title	Validation of novel biosensor device in patients with cardiovascular disease for development of driver-assistance system in response to drivers health status (Validation of novel biosensor and driver-assistance system)
Public Title	Validation of novel biosensor for driver-assistance system (Novel biosensor and driver-assistance system)

Completion date	Mar. 11, 2021
Result actual enrolment	30
Baseline Characteristics	A healthy adult who has driver licence
Participant flow	Participant registration and study were closed earlier than the date as planned due to the pandemic of COVID-19.
Adverse events	None
Outcome measures	During driving simulation, altered heat rate and ST-T changes were recorded. No lethal arrhythmia was found during this study.
Brief summary	The ECG monitoring system by DCP-100 is useful for non-invasive monitoring of cardaic condition during vehicle driving,
Date of posting of results summaries	Mar. 31, 2022

Plan to share IPD	No
Plan description	No
URL link to protocol file(s) with version and date	https://jrct.mhlw.go.jp/latest-detail/jRCTs042180029

Contact for Scientific Queries	Name	Murohara Toyoaki
	Affiliation	Nagoya University Hospital
	Address	65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
	Telephone	+81-52-744-2147
	E-mail	murohara@med.nagoya-u.ac.jp
Contact for Public Queries	Name	Bando Yasuko
	Affiliation	Nagoya University Hospital
	Address	65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
	Telephone	+81-52-744-2147
	E-mail	ybando@med.nagoya-u.ac.jp

Recruitment status	Complete

Anticipated date of first enrollment		Sept. 25, 2018
Actual date of first enrollment		Sept. 25, 2018
Target sample size		45
Study Type		Interventional
Study Design	allocation	non-randomized controlled trial
	masking	open(masking not used)
	control	uncontrolled control
	assignment	parallel assignment
	purpose	health services research
Key inclusion & exclusion criteria	Inclusion Criteria	Minimum 20 year-old Outpatients and Inpatients who are diagnosed any cardiovascular disease and/or cardiac arrhythimia Both gender Healthy control who has no past history of any cardiovascular disease and/or cardiac arrhythimia
	Exclusion Criteria	Under 20 year-old Patients who has contraindicative condition such as unstable angina or fatal arrhythmia. Patients/healthy volunteer who have exercise restriction Patients/healthy volunteer who are diagnosed as inappropriate for assignment
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Cardiac arrhythmia
Intervention(s)		Driving simulator
Intervention(s) Keyword		Training, Simulation
Health Condition(s) Code		D001145
Intervention(s) Code		D000066908
Primary Outcome(s)		Abnormal condition detected by wearable biosensor
Secondary Outcome(s)		Biosignals obtained under normal and physiological condition

Source of Monetary Support / Secondary Sponsor	DENSO COOPORATION
Secondary Sponsor	Applicable

Source of Monetary Support	DENSO COOPOPRATION
Secondary Sponsor	Applicable

Name of Certified Review Board	Nagoya University Certified Review Board
Address	65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan, Aichi
Telephone	+81-52-744-2479
E-Mail	ethics@med.nagoya-u.ac.jp
Approval Status	Approval
Date of approval	Sept. 25, 2018

Secondary ID(s)	該当しない
Issuing Authority	Not applicable

Countries of Recruitment（Except Japan）	none

History of Changes

List of change history