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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000021941
Receipt No. R000025304
Scientific Title Measurement of biological signals for circadian rhythm assessment in humans and analysis of the algorithm
Date of disclosure of the study information 2016/04/20
Last modified on 2016/06/27

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Basic information
Public title Measurement of biological signals for circadian rhythm assessment in humans and analysis of the algorithm
Acronym Measurement of biological signals for circadian rhythm assessment in humans and analysis of the algorithm
Scientific Title Measurement of biological signals for circadian rhythm assessment in humans and analysis of the algorithm
Scientific Title:Acronym Measurement of biological signals for circadian rhythm assessment in humans and analysis of the algorithm
Region
Japan

Condition
Condition healty males
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Find a method to assess the circadian rhythm of simple and easy in humans
Basic objectives2 Others
Basic objectives -Others The objective judgment of the body rhythm
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes rectal temperatue in the laboratory of 24 hours
Key secondary outcomes ear temperature in th laboratory of 24 hours

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Other
Interventions/Control_1 living in laboratory for 24 hours
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
40 years-old >=
Gender Male
Key inclusion criteria healty
Key exclusion criteria psychology disorder judgment from CMI index
mediation
smoker
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomoko Wakamura
Organization Kyoto University, Graduate school of medicine
Division name Human health Science
Zip code
Address 53 Kawahara-cho, Syogoin Sakyo-ku Kyoto
TEL 075-751-3974
Email wakamura.tomoko.5v@kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomoko Wakamura
Organization Kyoto University, Graduate school of medicine
Division name Human health Science
Zip code
Address 53 Kawahara-cho, Syogoin Sakyo-ku Kyoto
TEL 075-751-3974
Homepage URL
Email wakamura.tomoko.5v@kyoto-u.ac.jp

Sponsor
Institute Kyoto University, Graduate school of medicine
Institute
Department

Funding Source
Organization JST
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
2016 Year 04 Month 20 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 Open public recruiting
Date of protocol fixation
2016 Year 04 Month 16 Day
Date of IRB
Anticipated trial start date
2016 Year 05 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 04 Month 16 Day
Last modified on
2016 Year 06 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025304

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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