UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050321 |
|---|---|
| Receipt number | R000057302 |
| Scientific Title | Investigation of the effect of organic light-emitting diode (OLED) illumination on melatonin secretion. |
| Date of disclosure of the study information | 2023/02/13 |
| Last modified on | 2024/01/22 08:20:28 |
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Basic information
Public title
Investigation of the effect of organic light-emitting diode illumination on melatonin secretion.
Acronym
Investigation of the effect of organic light-emitting diode illumination on melatonin secretion.
Scientific Title
Investigation of the effect of organic light-emitting diode (OLED) illumination on melatonin secretion.
Scientific Title:Acronym
Investigation of the effect of organic light-emitting diode (OLED) illumination on melatonin secretion.
Region
| Japan |
Condition
Condition
Adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify that OLED lighting reduces melatonin secretion suppression compared to general lighting and is suitable for nighttime use.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
melatonin suppression
Key secondary outcomes
Melatonin concentration, melatonin onset, Sleep indices (sleep efficiency, sleep latency, sleep depth, arousal during sleep wake after sleep onset, sleepiness (reaction rate, response rate, variability of response rate, correct response rate), autonomic nervous system (autonomic balance, parasympathetic nervous system activity)
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 patients will be irradiated (at rest) in the test lighting environment for 300 minutes, during which melatonin samples will be taken every 30 minutes and PVT will be performed every 60 minutes.
Interventions/Control_2
The patients will be irradiated (at rest) in a control lighting environment for 300 minutes, during which melatonin samples will be taken every 30 minutes and PVT will be performed every 60 minutes.
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
| 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
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 are allergic to metals
12) Those who cannot stop consuming caffeine or alcohol during the study period.
13) Patients with mental illness
14) Participation in other clinical trials *Last 1 month
Target sample size
25
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 | 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, JAPAN
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
Shiba Palace Clinic Ethics Review Committee
Address
DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, JAPAN
Tel
03-5408-1599
shiba_palace@s-palace-clinic.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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 02 | Month | 13 | 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 | 01 | Month | 31 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 09 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 13 | Day |
Last follow-up date
| 2023 | 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
| 2023 | Year | 02 | Month | 13 | Day |
Last modified on
| 2024 | Year | 01 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057302
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