UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Pilot study of device of watch type in circadian rhythm (DWCR) in healthy human volunteers
Title of the study (Brief title)	Pilot study of DWCR
Region	Japan

Condition
Condition	healthy volunteers
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Locomotion, skin temperature and brightness are recorded consecutively by Device of watch type in Circadian rhythm. Core temperature, Psychomotor Vigilance Task (PVT) and concentration of saliva melatonin also are monitoring. These data are calculated for the algorithm of personal circadian rhythm.
Basic objectives2	Others
Basic objectives -Others	To acquire data for algorithm
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To acquire data for algorithm
Key secondary outcomes	To confirm defect of device

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	65 years-old >
Gender	Male
Key inclusion criteria	Subjects are all healthy male, age 20 - 65 years
Key exclusion criteria	No disease for having sleeping effects is allowed No medication for having sleeping effects is allowed All subjects are required to attach DWCR and keep the diary during hospital Nonsmoking
Target sample size	7

Research contact person
Name of lead principal investigator	Jyunya Tanimoto
Organization	O: INC
Division name	Founder/CEO
Address	2-18-3, Shimomeguro, Meguro-ku, Tokyo 153-0064, Japan
TEL	080-9389-6343
Email	info@o-inc.jp

Public contact
Name of contact person	Jyunya Tanimoto
Organization	O: INC
Division name	Founder/CEO
Address	2-18-3, Shimomeguro, Meguro-ku, Tokyo 153-0064, Japan
TEL	080-9389-6343
Homepage URL
Email	info@o-inc.jp

Sponsor
Institute	O: INC
Institute
Department

Funding Source
Organization	NEDO
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2018 Year 05 Month 29 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 04 Month 25 Day
Anticipated trial start date	2018 Year 05 Month 25 Day
Last follow-up date	2018 Year 06 Month 30 Day
Date of closure to data entry	2018 Year 07 Month 31 Day
Date trial data considered complete	2018 Year 08 Month 31 Day
Date analysis concluded	2018 Year 09 Month 30 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	English

Management information
Registered date	2018 Year 05 Month 29 Day
Last modified on	2018 Year 11 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036929