UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054633 |
|---|---|
| Receipt number | R000062433 |
| Scientific Title | Investigation of methods to improve the effects of night shift on biological rhythms and sleep using lighting fixtures. |
| Date of disclosure of the study information | 2024/06/12 |
| Last modified on | 2025/12/14 11:24:28 |
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Basic information
Public title
Does changing lighting fixtures improve the impact of night shifts on shift workers?
Acronym
Experiments with lighting fixtures for night shifts.
Scientific Title
Investigation of methods to improve the effects of night shift on biological rhythms and sleep using lighting fixtures.
Scientific Title:Acronym
Experiments with lighting fixtures for night shifts.
Region
| Japan |
Condition
Condition
Circadian rhythm sleep disorder
Classification by specialty
| Endocrinology and Metabolism | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To reduce the stress associated with night work for nurses, three types of lighting fixtures will be compared and evaluated in terms of biological rhythm and stress level as indicators: day-white LEDs, which are conventionally used, bulb-coloured LEDs, and new LEDs that combine day-white and bulb-coloured LEDs and set the emission ratio to be in sync with biological rhythm.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Melatonin concentration
Key secondary outcomes
a. cortisol concentration in hair
b. Melatonin concentration in blood
c. Melatonin concentration in saliva
d. Diurnal rhythm of deep body temperature
e. Sleep diary
f. Questionnaire survey of mental and sleep indicators
g. Number of overtime hours worked
h. Assessment by activity meters.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Group A participants will work for 40 days in an environment using cool white LEDs, followed by 40 days in an environment using warm white LEDs (from 9 PM to 6 AM the next day). After this, they will again work for 40 days in an environment with cool white LEDs, and then for 40 days in an environment using adjustable warm white LEDs (from 9 PM to 6 AM the next day). During this last phase, they will work under warm white light from 9 PM to 3 AM, transitioning gradually from warm white to cool white light from 3 AM to 6 AM.
Group B participants will work for 40 days in an environment using cool white LEDs, followed by 40 days in an environment using adjustable warm white LEDs (from 9 PM to 6 AM the next day). After this, they will again work for 40 days in an environment with cool white LEDs, and then for 40 days in an environment using warm white LEDs (from 9 PM to 6 AM the next day).
In this manner, a crossover experiment will be conducted between Group A and Group B.
Interventions/Control_2
Research collaborators in Group B will work for 40 days in an environment using cool white LEDs, followed by 40 days in an environment using adjustable warm white LEDs (with warm white from 9 PM to 3 AM the next day, gradually transitioning to cool white from 3 AM to 6 AM). After this, they will again work for 40 days in an environment using cool white LEDs, and then for another 40 days in an environment using warm white LEDs.
Interventions/Control_3
In this way, a crossover experiment will be conducted between Group A and Group B.
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
| 20 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Nurses working in the research facility who meet all of the following criteria.
1) Place of work: ward A or ward B of the research facility.
2) Healthy at the time of study participation and not having taken any medication continuously in the last three months.
3) Age: between 20 and 70 years of age at the time consent is obtained.
4) Gender: any gender
5) Written consent to participate in research: the research participants freely and voluntarily consented to the document.
Key exclusion criteria
1) If the research participant's free and voluntary written consent cannot be obtained
2) People who have been using drugs regularly in the last 3 months.
3) People who have gained or lost weight rapidly.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Fumihisa |
| Middle name | |
| Last name | Miyauchi |
Organization
Japan Community Healthcare Organization Uwajima Hospital
Division name
internal medicine
Zip code
798-0053
Address
2-1-37, Kako-cho, Uwajima, Ehime 798-0053, Japan
TEL
0895-22-5616
miyauchi-humihisa@uwajima.jcho.go.jp
Public contact
Name of contact person
| 1st name | Fumihisa |
| Middle name | |
| Last name | Miyauchi |
Organization
Japan Community Healthcare Organization Uwajima Hospital
Division name
internal medicine
Zip code
798-0053
Address
2-1-37, Kako-cho, Uwajima, Ehime 798-0053, Japan
TEL
0895-22-5616
Homepage URL
miyauchi-humihisa@uwajima.jcho.go.jp
Sponsor or person
Institute
Japan Community Healthcare Organization Uwajima Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Community Healthcare Organization
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Japan Community Healthcare Organization Uwajima Hospital
Address
2-1-37, Kako-cho, Uwajima, Ehime 798-0053, Japan
Tel
0895-22-5616
miyauchi-humihisa@uwajima.jcho.go.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
| 2024 | Year | 06 | Month | 12 | 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
19
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 | 20 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 20 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 12 | 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 | 06 | Month | 12 | Day |
Last modified on
| 2025 | Year | 12 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062433
