UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044063 |
|---|---|
| Receipt number | R000050310 |
| Scientific Title | A Study on the Effect of Colored LED Lighting on Human Body in Living Room |
| Date of disclosure of the study information | 2021/07/01 |
| Last modified on | 2021/04/28 13:16:48 |
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Basic information
Public title
A Study on the Effect of Colored LED Lighting on Human Body in Living Room
Acronym
A Study on the Effect of Colored LED Lighting on Human Body in Living Room
Scientific Title
A Study on the Effect of Colored LED Lighting on Human Body in Living Room
Scientific Title:Acronym
A Study on the Effect of Colored LED Lighting on Human Body in Living Room
Region
| Japan |
Condition
Condition
Healthy person
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The basic aims of this study is to examine the relationship between chromatic light and human stress using ECG and saliva analysis.
Basic objectives2
Others
Basic objectives -Others
The specific aim of this study is to clarify the effects of mixed light and stress in addition to monochromatic light.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
HRV will be measured and saliva will be obtained within 2-hours experiment per week, and this section will be repeated 7 times.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment |
Interventions/Control_1
2-hours experiment per week will be conducted 7 times.
HRV will be measured through the experiment.
Saliva will be obtained 5 times per one experiment.
Interventions/Control_2
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
| 29 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Students of Tokyo University of Science, aged 20-29.
Healthy persons without insomnia, etc.
Normal colour sense
The meal should be done 2 hours before the experiment.
Caffain drink should not be taken from 6 hours before the experiment.
Excercise should refrain from 6 hours before the experiment.
Alcohol should refrain from 24 hours before the experiment.
No habitual use of drugs.
HRV measurement and saliva gathering can be approved.
Key exclusion criteria
Those who do not satisfy the demands above.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Nozomu |
| Middle name | |
| Last name | Yoshizawa |
Organization
Tokyo University of Science
Division name
Department of Architecture, Faculty of Science and Engineering
Zip code
278-8510
Address
2641 Yamazaki, Noda, Chiba
TEL
04-7122-9468
yoshizawa@rs.tus.ac.jp
Public contact
Name of contact person
| 1st name | Nozomu |
| Middle name | |
| Last name | Yoshizawa |
Organization
Tokyo University of Science
Division name
Department of Architecture, Faculty of Science and Engineering
Zip code
278-8510
Address
2641 Yamazaki, Noda, Chiba
TEL
04-7122-9468
Homepage URL
yoshizawa@rs.tus.ac.jp
Sponsor or person
Institute
Tokyo University of Science
Institute
Department
Personal name
Funding Source
Organization
Tokyo University of Science
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo University of Science
Address
2641 Yamazaki, Noda, Chiba
Tel
0471229468
yoshizawa@rs.tus.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
| 2021 | Year | 07 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
25
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
| 2020 | Year | 09 | Month | 18 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 13 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 13 | Day |
Last follow-up date
| 2021 | 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
| 2021 | Year | 04 | Month | 28 | Day |
Last modified on
| 2021 | Year | 04 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050310
