UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000054488
Receipt number R000062013
Scientific Title Investigation of the relationship between organic light-emitting diode (OLED) lighting and fatigue/wellness
Date of disclosure of the study information 2024/05/27
Last modified on 2025/03/14 15:25:16

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Basic information

Public title

Investigation of the relationship between organic light-emitting diode (OLED) lighting and fatigue or health

Acronym

Investigation of the relationship between organic light-emitting diode (OLED) lighting and fatigue or health

Scientific Title

Investigation of the relationship between organic light-emitting diode (OLED) lighting and fatigue/wellness

Scientific Title:Acronym

Investigation of the relationship between organic light-emitting diode (OLED) lighting and fatigue or health

Region

Japan


Condition

Condition

Adult

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Investigation of anti-fatigue and health-promotion effects of OLED lighting on healthy adults

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Autonomic nerve function (heart rate and frequency components of heart rate variability)

Key secondary outcomes

Visual analogue scale (VAS) score for subjective sensation, performance of cognitive function task (reaction time and rate of correct answer), quality of sleep, and fatigue-related questionnaire scores



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


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

Research site with OLED lighting

Interventions/Control_2

Research site with LED lighting

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 have been employees of KANEKA CORPORATION
2)Those who are between 18 and 70 years of age and are healthy adults
3)Those who understand the content of the research and are able to express their willingness to give consent
4)Those who do not meet the following exclusion criteria and gave written consent

Key exclusion criteria

1)Those who have a history of serious illnesses
2)Those who have a history of seizures(loss of consciousness, coma, convulsions, etc.)based on neurological disease
3)Those who are considered unsuitable for the research by the researchers

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Kei
Middle name
Last name Mizuno

Organization

Osaka Metropolitan University

Division name

Center for Health Science Innovation

Zip code

530-0011

Address

9F, Tower C, Grand Front Osaka North Tower, 3-1 Ofuka-cho, Kita-Ku, Osaka, JAPAN

TEL

06-6485-0288

Email

gr-knky-chsi@omu.ac.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


Email

Tomoki.Kubo@kaneka.co.jp


Sponsor or person

Institute

Osaka Metropolitan University

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, Center for Health Science Innovation, Osaka Metropolitan University

Address

9F, Tower C, Grand Front Osaka North Tower, 3-1 Ofuka-cho, Kita-ku, Osaka

Tel

06-6485-0288

Email

gr-knky-chsi@omu.ac.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

株式会社カネカ高砂工業所(兵庫県)
株式会社カネカ大阪工場(大阪府)


Other administrative information

Date of disclosure of the study information

2024 Year 05 Month 27 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

No longer recruiting

Date of protocol fixation

2024 Year 02 Month 26 Day

Date of IRB

2024 Year 02 Month 26 Day

Anticipated trial start date

2024 Year 05 Month 28 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 05 Month 27 Day

Last modified on

2025 Year 03 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062013