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

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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 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

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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name