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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000032759
Receipt No. R000036929
Scientific Title Pilot study of device of watch type in circadian rhythm (DWCR) in healthy human volunteers
Date of disclosure of the study information 2018/05/29
Last modified on 2018/11/28

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Basic information
Public title Pilot study of device of watch type in circadian rhythm (DWCR) in healthy human volunteers
Acronym Pilot study of DWCR
Scientific Title Pilot study of device of watch type in circadian rhythm (DWCR) in healthy human volunteers
Scientific Title:Acronym 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
1st name
Middle name
Last name Jyunya Tanimoto
Organization O: INC
Division name Founder/CEO
Zip code
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
1st name
Middle name
Last name Jyunya Tanimoto
Organization O: INC
Division name Founder/CEO
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2018 Year 04 Month 25 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000036929

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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