UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042141
Receipt No. R000048091
Scientific Title Research on the effect of light stimulation control throughout the day on photoreceptors related to circadian rhythm based on metamerism for change in illuminant design method on human health
Date of disclosure of the study information 2020/11/01
Last modified on 2020/10/16

* 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 Research on the effect of light stimulation control throughout the day on photoreceptors related to circadian rhythm based on metamerism for change in illuminant design method on human health
Acronym Research on the effect of light stimulation control throughout the day on photoreceptors related to circadian rhythm based on metamerism for change in illuminant design method on human health
Scientific Title Research on the effect of light stimulation control throughout the day on photoreceptors related to circadian rhythm based on metamerism for change in illuminant design method on human health
Scientific Title:Acronym Research on the effect of light stimulation control throughout the day on photoreceptors related to circadian rhythm based on metamerism for change in illuminant design method on human health
Region
Japan

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

Objectives
Narrative objectives1 The purpose of the research is to clarify the effect of daily light environment differences on melatonin secretion.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Dim Light Melatonin Onset (DLMO) after light exposure
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 Color temperature is 6500k from 0700 3100K from 1630, mRGC is 20 from 0700 14 from 1630
Interventions/Control_2 Color temperature is 1200K from 0700 to 0715, 3100K from 1630, mRGC keeps stimulation after 40 from 0700 to 0715, gradually decreases after 14 from 1630 to 1800
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 eople with mental or physical disorders as determined by the Cornell Medical Index.
Extremely Morningness-type determined by Morningness-Eveningness questionnaire.
People with sleep disorders as determined by Pittsburgh sleep quality index.
Target sample size 20

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 ELM Inc.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization 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

Other administrative information
Date of disclosure of the study information
2020 Year 11 Month 01 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
2020 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2020 Year 11 Month 01 Day
Last follow-up date
2021 Year 06 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 10 Month 16 Day
Last modified on
2020 Year 10 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048091

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.