UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042141 |
|---|---|
| Receipt number | 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 17:35:33 |
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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
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
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048091
