UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032759 |
|---|---|
| Receipt number | 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 17:47:02 |
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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
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
info@o-inc.jp
Sponsor or person
Institute
O: INC
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036929
| Research Plan | |
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| Registered date | File name |
| Research case data | |
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