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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000040826
Receipt No. R000046608
Scientific Title A Study on Stress under Chromatic LEDs in Residential S paces
Date of disclosure of the study information 2020/07/01
Last modified on 2020/06/19

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Basic information
Public title A Study on Stress under Chromatic
LEDs in Residential S paces
Acronym A Study on Stress under Chromatic
LEDs in Residential S paces
Scientific Title A Study on Stress under Chromatic
LEDs in Residential S paces
Scientific Title:Acronym A Study on Stress under Chromatic
LEDs in Residential S paces
Region
Japan

Condition
Condition Healthy person
Classification by specialty
Not applicable Adult
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 effect of the Red/Blue/Green light on the human stress.
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 40

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
Email 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
Email yoshizawa@rs.tus.ac.jp

Sponsor
Institute Tokyo University of Science
Institute
Department

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
Email 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
2020 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 28
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 09 Month 27 Day
Date of IRB
2019 Year 10 Month 03 Day
Anticipated trial start date
2019 Year 10 Month 04 Day
Last follow-up date
2020 Year 06 Month 30 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 06 Month 19 Day
Last modified on
2020 Year 06 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046608

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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