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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038350
Receipt No. R000043240
Scientific Title The effect of daytime light environment on circadian rhythm of urination
Date of disclosure of the study information 2019/11/10
Last modified on 2019/10/21

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Basic information
Public title The effect of daytime light environment on circadian rhythm of urination
Acronym The effect of daytime light environment on circadian rhythm of urination
Scientific Title The effect of daytime light environment on circadian rhythm of urination
Scientific Title:Acronym The effect of daytime light environment on circadian rhythm of urination
Region
Japan

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

Objectives
Narrative objectives1 The purpose is to clarify whether the difference in the daytime light environment affects the subsequent urination volume, urine flow rate, and urine components.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Urination volume
Key secondary outcomes Urine biochemistry

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 The light environment during the day (10: 00-18: 00) at 50 lx.
Interventions/Control_2 The light environment during the day (10: 00-18: 00) at 1000 lx.
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
30 years-old >=
Gender Male
Key inclusion criteria Non-smoking person.
People who have not taken any medicines including sleeping pills.
People who usually go to sleep from 23:00 to 1:00 h and wake up from 6:00 to 8:00 h.
Key exclusion criteria People with mental or physical disorders as determined by the Cornell Medical Index.
Extremely Morningness-type or Extremely Eveningness-type determined by Morningness-Eveningness questionnaire.
People with sleep disorders as determined by Pittsburgh sleep quality index.
People with dysuria as determined by International Prostate Symptom Score.
Target sample size 35

Research contact person
Name of lead principal investigator
1st name Tomoko
Middle name
Last name Wakamura
Organization Kyoto University
Division name Human Health Sciences, Graduate School of Medicine
Zip code 606-8507
Address 53, Shogoin, Kawahara-cho, Sakyo-ku, Kyoto
TEL 81-75-751-3974
Email wakamura.tomoko.5v@kyoto-u.ac.jp

Public contact
Name of contact person
1st name Tomoko
Middle name
Last name Wakamura
Organization Kyoto University
Division name Human Health Sciences, Graduate School of Medicine
Zip code 606-8507
Address 53, Shogoin, Kawahara-cho, Sakyo-ku, Kyoto
TEL 81-75-751-3974
Homepage URL
Email wakamura.tomoko.5v@kyoto-u.ac.jp

Sponsor
Institute Kyoto University
Institute
Department

Funding Source
Organization Kaken
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 by Kyoto University Graduate School and Faculty of Medicine Ethics Committee
Address Konoe-cho, Sakyo-ku, Kyoto
Tel 075-753-4680
Email ethcom@kuhp.kyoto-u.ac.jp

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 京都大学医学研究科人間健康科学科 (京都府)

Other administrative information
Date of disclosure of the study information
2019 Year 11 Month 10 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 Preinitiation
Date of protocol fixation
2019 Year 11 Month 10 Day
Date of IRB
Anticipated trial start date
2019 Year 11 Month 10 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 10 Month 21 Day
Last modified on
2019 Year 10 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043240

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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