UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054158 |
|---|---|
| Receipt number | R000061809 |
| Scientific Title | Investigation of the effects of organic light-emitting diode (OLED) lighting on sleep and fatigue |
| Date of disclosure of the study information | 2024/04/15 |
| Last modified on | 2024/04/15 10:00:34 |
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Basic information
Public title
Investigation of the effects of organic light-emitting diode (OLED) lighting on sleep and fatigue
Acronym
Investigation of the effects of organic light-emitting diode (OLED) lighting on sleep and fatigue
Scientific Title
Investigation of the effects of organic light-emitting diode (OLED) lighting on sleep and fatigue
Scientific Title:Acronym
Investigation of the effects of organic light-emitting diode (OLED) lighting on sleep and fatigue
Region
| Japan |
Condition
Condition
Adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Long-term investigation of the effects of OLED lighting on sleep and fatigue in a residential environment
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Melatonin secretion, Sleep indices, Autonomic nervous system, cognitive function
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
Daily lives in the homes with an OLED lighting environment for 2 months
Interventions/Control_2
Daily lives in the homes with an LED lighting environment for 2 months
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
| 18 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Those who live in the designated apartment and aged between 18 and 70 years old
2)Those who are healthy and not undergoing any kind of medical treatment
3) Those who do not regularly use medicines
4)Those who are not taking sleep supplements(such as melatonin ,tryptophan )
5)Those who are not engaged in night shift/shift work
6) Those who are capable of keeping records
7)Those who have consented to this study in writing
Key exclusion criteria
1)Those who have ophthalmologic diseases
2)Those with PSQI 6 or more
3)Those with BMI 25 or more
4)Those who need dental care
5)Those who cannot refrain from taking food for specified health use, functional foods, or other so-called health foods during the study period
6)Those who have traveled to different time zones within the last 1 month
7)Those who may consume excessive amounts of caffeine and alcohol during the light intervention period
8)Those who have mental illness
9)Those who have participated in other clinical studies within the last 1 month
10)Those who are allergic to metals
Target sample size
100
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 Business Development Group Applied Technology Team
Zip code
107-6090
Address
1-12-32 Akasaka, Minato-ku, Tokyo, JAPAN
TEL
03-5574-8000
youichi.yamaguchi1@kaneka.co.jp
Public contact
Name of contact person
| 1st name | Tomoki |
| Middle name | |
| Last name | Kubo |
Organization
KANEKA CORPORATION
Division name
OLED Business Development Project Business Development Group Applied Technology Team
Zip code
107-6090
Address
1-12-32 Akasaka, Minato-ku, Tokyo, JAPAN
TEL
03-5574-8000
Homepage URL
Tomoki.Kubo@kaneka.co.jp
Sponsor or person
Institute
KANEKA CORPORATION
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
HASEKO Corporation
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical review committee, Kanazawabunko Hospital
Address
2-6-22 Kamariya Higashi, Kanazawa-ku, Yokohama, Kanagawa
Tel
0570-783-706
r.yokohama@kanabun-hp.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
指定されたマンション（千葉県）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 04 | Month | 15 | 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
| 2024 | Year | 04 | Month | 05 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 05 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 15 | Day |
Last follow-up date
| 2026 | 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
| 2024 | Year | 04 | Month | 15 | Day |
Last modified on
| 2024 | Year | 04 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061809
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
