UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052648 |
|---|---|
| Receipt number | R000060019 |
| Scientific Title | Investigation of the effects of organic light-emitting diode (OLED) illumination on melatonin secretion and sleep. |
| Date of disclosure of the study information | 2023/10/30 |
| Last modified on | 2025/03/13 16:45:47 |
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Basic information
Public title
Investigation of the effects of organic light-emitting diode illumination on melatonin secretion and sleep.
Acronym
Investigation of the effects of organic light-emitting diode illumination on melatonin secretion and sleep.
Scientific Title
Investigation of the effects of organic light-emitting diode (OLED) illumination on melatonin secretion and sleep.
Scientific Title:Acronym
Investigation of the effects of organic light-emitting diode (OLED) illumination on melatonin secretion and sleep.
Region
| Japan |
Condition
Condition
Adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the effects of light environments of general LED lighting, OLED lighting, and OLED lighting with further reduced blue light on melatonin secretion and sleep.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Melatonin secretion, Sleep indices
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
5
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
The patient will be irradiated for 300 minutes (melatonin test) in an OLED lighting environment with further reduction of blue light.
Interventions/Control_2
The patient will be irradiated for 300 minutes (melatonin test) in an OLED lighting environment.
Interventions/Control_3
The patient will be irradiated for 240 minutes (sleep test) in an OLED lighting environment with further reduction of blue light.*Details to be determined by melatonin test results.
Interventions/Control_4
The patient will be irradiated for 240 minutes (sleep test) in an OLED lighting environment.*Details to be determined by melatonin test results.
Interventions/Control_5
The patient will be irradiated for 240 minutes (sleep test) in a general LED lighting.*Details to be determined by melatonin test results.
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
| 35 | years-old | >= |
Gender
Male
Key inclusion criteria
1) Japanese males aged 18 to 35 years old.
2) Healthy subjects not receiving any medical treatment
3) No medication use.
4) Not taking any sleeping supplements(Functional foods that claim to improve sleep quality, such as melatonin supplements and tryptophan supplements)
5) Not engaged in night shift/shift work
6) Habitual sleeping hours of 7 to 9 hours
7) Those whose habitual bedtime is between 23:00 and 25:00
8) Able to make designated visits and fill in records
9) The subject must have given written consent to this study.
Key exclusion criteria
1) With ophthalmologic disease
2) PSQI more than 6
3) BMI more than 25
4) MEQ 30 or less or MEQ more than70
5) Patients who need dental treatment
6) Those with irregular lifestyle
7) AUDIT more than 15
8) Smokers
9-1) Those who cannot refrain from taking food for specified health use, functional foods, or other so-called health foods during the study period
9-2) Those who are unable to refrain from taking foods for specified health use, foods with functional claims, or other so-called health foods during the test period
10) Those who have traveled to time zone within the last 1 month.
11) Those who cannot stop consuming caffeine or alcohol during the study period.
12) Patients with mental illness
13) Participation in other clinical trials *Last 1 month
14) Those who are allergic to metals(Exclusion criteria only in sleep studies)
Target sample size
42
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, JAPAN
TEL
03-5574-8000
youichi.yamaguchi1@kaneka.co.jp
Public contact
Name of contact person
| 1st name | Masako |
| Middle name | |
| Last name | Mizuuchi |
Organization
APO PLUS STATION CO., LTD.
Division name
Clinical Operations Dept., CRO Business div.
Zip code
1030027
Address
2-14-1,Nihonbashi,Chuo-ku,Tokyo, Japan
TEL
03-6386-8809
Homepage URL
food-contact@apoplus.co.jp
Sponsor or person
Institute
APO PLUS STATION CO., LTD.
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
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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 10 | Month | 30 | 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
Completed
Date of protocol fixation
| 2023 | Year | 10 | Month | 16 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 16 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 31 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
1.The planned sample size is 12 subjects for the melatonin study and 30 subjects for the sleep study, but the precise sample size of the sleep study will be estimated based on the result of the melatonin study.
2.The contents of the interventions for the sleep study (interventions 3-5)is to be finalized based on the result of the melatonin study.
Management information
Registered date
| 2023 | Year | 10 | Month | 30 | Day |
Last modified on
| 2025 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060019
