UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055636 |
|---|---|
| Receipt number | R000063563 |
| Scientific Title | Investigation of the effects of organic light-emitting diode lighting on sleep |
| Date of disclosure of the study information | 2024/09/26 |
| Last modified on | 2025/03/13 16:52:56 |
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Basic information
Public title
Investigation of the effects of organic light-emitting diode lighting on sleep
Acronym
Investigation of the effects of organic light-emitting diode lighting on sleep
Scientific Title
Investigation of the effects of organic light-emitting diode lighting on sleep
Scientific Title:Acronym
Investigation of the effects of organic light-emitting diode lighting on 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 with general LED lighting, OLED lighting, and OLED lighting with less short-wavelength light on sleep
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Objectively measured sleep latency
Key secondary outcomes
1) Objectively measured sleep parameters (TST(min); N1, N2, N3, REM (min, %); SE(%); N3 onset latency(min); REM onset latency(min); WASO(min, %))
2) Changes in sleep parameters (sleep latency(min); TST(min); N1, N2, N3, REM (min, %); SE(%); N3 onset latency(min); REM onset latency(min); WASO(min, %)) from baseline
3) Sleep questionnaire (Ogri-Shirakawa-Azumi sleep inventory MA version)
4) The number of rising during sleep time
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
3
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Four-hours light exposure to OLED lighting with less short-wavelength light before bedtime
Interventions/Control_2
Four-hours light exposure to OLED lighting before bedtime
Interventions/Control_3
Four-hours light exposure to general LED lighting before bedtime
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) Healthy Japanese males aged 18 to 35 years old
2) Those whose habitual bedtime is between 23:00 and 25:00
3) Those whose habitual sleep time is 7 to 9 hours
Key exclusion criteria
Individuals with
1) Any current medical treatment
2) Current or past psychiatric diseases
3) Sleep disorder
4) Sleep apnea syndrome or aware of sleep apnea
5) Any eye diseases
6) Intake of any medication
7) Intake of any quasi-drugs, health foods or supplements that may affect the study
8) PSQI >=6
9) MEQ <=30 or MEQ >=70
10) BMI >=25
11) AUDIT >=15
12) Current smokers
13) Current night-shift workers or shift workers
14) Traveling to time zone within the past month
15) Participation in other clinical trials within the past month
16) Allergic to metals or sensitive skin
Target sample size
24
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
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
株式会社カネカ未来創造館(兵庫県)
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 09 | Month | 26 | 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
| 2024 | Year | 09 | Month | 09 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 11 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 26 | Day |
Last follow-up date
| 2025 | 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
| 2024 | Year | 09 | Month | 26 | 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=R000063563
