UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052650 |
|---|---|
| Receipt number | R000060067 |
| Scientific Title | Investigation of the effects of organic light-emitting diode (OLED) lighting on fatigue-related symptoms, quality of life, and productivity. |
| Date of disclosure of the study information | 2023/10/30 |
| Last modified on | 2023/10/30 09:10:11 |
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Basic information
Public title
Investigation of the effects of organic light-emitting diode (OLED) lighting on fatigue-related symptoms, quality of life, and productivity.
Acronym
Effects of OLED Lighting on Fatigue-Related Symptoms, Quality of Life, and Productivity
Scientific Title
Investigation of the effects of organic light-emitting diode (OLED) lighting on fatigue-related symptoms, quality of life, and productivity.
Scientific Title:Acronym
Effects of OLED Lighting on Fatigue-Related Symptoms, Quality of Life, and Productivity
Region
| Japan |
Condition
Condition
Child, Adult
Classification by specialty
| Not applicable | Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify that OLED lighting reduces the load on the body and mind compared to general lighting, and to verify the effectiveness of OLED lighting in improving fatigue-related symptoms, quality of life, and productivity.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Autonomic nervous system (autonomic balance, parasympathetic activity)
Key secondary outcomes
Sleepiness index (reaction speed, variability of reaction speed, percentage of correct responses) by PVT, cognitive function index (task performance time, number of responses, number of incorrect responses) by Trail Making Test Japan (TMT-J), number of blinks, subjective evaluation (eye fatigue, attention span, tension) by Visual Analog Scale (VAS) Tension level)
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
The participants will perform two tasks in a test lighting environment for approximately one hour each (although the tasks may be shortened to 15, 30, or 45 minutes) and will measure autonomic activity before and after the task by resting with closed eyes for 2 minutes. The VAS and responses to a questionnaire will then be administered.
Interventions/Control_2
The participants will perform two tasks in a control lighting environment for approximately one hour each (although the task may be shortened to 15, 30, or 45 minutes), and before and after the task, they will measure autonomic activity by resting with their eyes closed for 2 minutes. The VAS and responses to a questionnaire will then be administered.
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
| 10 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(i) No problem in normal social and daily life
(ii) Not a patient with a serious lifestyle-related disease or mental illness
(iii) Consent of a surrogate is obtained (in the case of a minor).
Key exclusion criteria
(i)Pregnant women and those who may be pregnant
(ii)Those who have a tendency to depression
(iii)Those who do not study for more than one hour daily outside of school (children)
Target sample size
800
Research contact person
Name of lead principal investigator
| 1st name | Youichi |
| Middle name | |
| Last name | YAMAGUCHI |
Organization
KANEKA CORPORATION
Division name
OLED Business Development Project Center of BusinessGroup OLED Lighting Design & Planning Team
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 | Naomi |
| Middle name | |
| Last name | ADACHI |
Organization
Medithink,Inc.
Division name
None
Zip code
108-0074
Address
2-1-13-1003, Takanawa, Minato-ku, Tokyo
TEL
03-6459-3960
Homepage URL
adachi@medithink.co.jp
Sponsor or person
Institute
KANEKA CORPORATION
Institute
Department
Personal name
Funding Source
Organization
KANEKA CORPORATION
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fatigue Science Laboratory Inc.
Address
7-4-21 Nishinakajima, Yodogawa-ku, Osaka-shi, Osaka
Tel
06-6308-1190
kuni@fatigue.co.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
| 2023 | Year | 10 | Month | 30 | 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
100
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
Main results already published
Date of protocol fixation
| 2019 | Year | 11 | Month | 17 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 17 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | 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
| 2023 | Year | 10 | Month | 30 | Day |
Last modified on
| 2023 | Year | 10 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060067
