UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000047445 |
|---|---|
| Receipt number | R000054101 |
| Scientific Title | Non-recessive randomized controlled trial under OLED illumination - Randomized crossover controlled trial |
| Date of disclosure of the study information | 2022/04/09 |
| Last modified on | 2022/07/08 08:55:04 |
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Basic information
Public title
Non-recessive randomized controlled trial under OLED illumination - Randomized crossover controlled trial
Acronym
Non-recessive randomized controlled trial under OLED illumination - Randomized crossover controlled trial
Scientific Title
Non-recessive randomized controlled trial under OLED illumination - Randomized crossover controlled trial
Scientific Title:Acronym
Non-recessive randomized controlled trial under OLED illumination - Randomized crossover controlled trial
Region
| Japan |
Condition
Condition
healthy subject
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
It has been clarified that OLED lighting is not inferior to general lighting in night workability even in dark places.
Basic objectives2
Others
Basic objectives -Others
Non-inferiority test
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Uchida-Kraepelin test(average number of answer)
Key secondary outcomes
average number of error, Karolinska sleepiness scale, KSS
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
irradiate for 30 minutes (at rest), rest for 5 minutes, and irradiate for 120 minutes (at work) under the study lighting environment, respectively.
Interventions/Control_2
irradiate for 30 minutes (at rest), rest for 5 minutes, and irradiate for 120 minutes (at work) under the control lighting environment, respectively.
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
| 49 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Japanese men and women between 20 and 50 years old at the time of obtaining consent
2) Healthy people who have not received any treatment
3) Designated visits, items that can fill in records
4) Those with general computing power
5) With a normal sleep of 7 hours or more
6) Those who have received sufficient explanations about the purpose and content of the examination and agree to participate in writing at will
Key exclusion criteria
1) Visual abnormalities *Colorblind, color weakness or eye disease
2) Lasik surgery/ Glasses, eye vision correction with contact lenses
3) Pregnant and lactating
4) Irregular lifestyle habits
5) Drinking more than 20 g per day
6) With more than 20 smoking per day
7) Foods for specified health use, foods with functional indications, and other foods that cannot be refrained from consuming so-called health foods during the study period
8) Participation in other clinical trials or clinical trials within the last month
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | Youichi |
| Middle name | KANEKA CORPORATION |
| Last name | Yamaguchi |
Organization
KANEKA CORPORATION
Division name
OLED Lighting Design & Planning Team Center of Business Group OLED Business Development Project
Zip code
107-6090
Address
1-12-32,Akasaka,Minato-ku Tokyo
TEL
03-5574-8000
youichi.yamaguchi1@kaneka.co.jp
Public contact
Name of contact person
| 1st name | Soichi |
| Middle name | |
| Last name | Yoneda |
Organization
Mibyou Life Science Inc.
Division name
Clinical Trial Division
Zip code
101-0061
Address
5F Tokuei Bldg., Kanda Misaki-cho, Chiyoda-ku, Tokyo, Japan
TEL
03-6256-9600
Homepage URL
renraku@mibyou-ls.com
Sponsor or person
Institute
Mibyou Life Science Inc.
Institute
Department
Personal name
Funding Source
Organization
KANEKA CORPORATION
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
Mibyou Research Ethics Review Committee
Address
2-18-4 Kandamisakicho,Chiyoda-ku, Tokyo
Tel
03-6272-9163
renraku@npo-mibyou.com
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
カネカ未来創造館（兵庫県）／Kaneka miraisouzoukan (Hyogo prefecture)
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 04 | Month | 09 | 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
32
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
| 2022 | Year | 03 | Month | 23 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 12 | Day |
Last follow-up date
| 2022 | 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
| 2022 | Year | 04 | Month | 09 | Day |
Last modified on
| 2022 | Year | 07 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054101
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| Research case data | |
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