UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038350 |
|---|---|
| Receipt number | 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 | 2020/04/21 11:55:11 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
wakamura.tomoko.5v@kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
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
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
Completed
Date of protocol fixation
| 2019 | Year | 11 | Month | 10 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 21 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 10 | Day |
Last follow-up date
| 2020 | Year | 02 | Month | 09 | Day |
Date of closure to data entry
| 2020 | Year | 02 | Month | 09 | Day |
Date trial data considered complete
| 2020 | Year | 02 | Month | 09 | Day |
Date analysis concluded
| 2021 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 10 | Month | 21 | Day |
Last modified on
| 2020 | Year | 04 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043240
