UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062727 |
|---|---|
| Receipt number | R000071817 |
| Scientific Title | Study of the physical and mental effects of environmental conditions on humans |
| Date of disclosure of the study information | 2026/08/28 |
| Last modified on | 2026/08/28 17:13:48 |
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Basic information
Public title
Study of the physical and mental effects of environmental conditions on humans
Acronym
Study of the physical and mental effects of environmental conditions on humans
Scientific Title
Study of the physical and mental effects of environmental conditions on humans
Scientific Title:Acronym
Study of the physical and mental effects of environmental conditions on humans
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
An influence of lighting conditions (color temperature, illuminance) on color discrimination will be discussed through a three-point discrimination test using ccolor rendering evaluation samples
Basic objectives2
Others
Basic objectives -Others
Optimal value, Favorite value
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Ease of color visibility (correct answer rate, response time)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Color temperature, Illuminance
Interventions/Control_2
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Four age categories for men and women: (1) 18-29 years old, (2) 30-44 years old, (3) 45-59 years old, (4) 60-74 years old.
Key exclusion criteria
Those who meet the following conditions are not eligible.
(1) Pregnant or breastfeeding.
(2) Having a smoking habit.
(3) Suffering from poor physical condition due to medical disease, neurological disease, mental illness, or any other cause.
(4) Diagnosed person with autonomic nervous system disorder, depression, mania, manic depression, or facial paralysis in the past (excluding those who have been cured or remitted).
(5) Regularly take tranquilizers or antihypertensive drugs, those who receive hormone replacement therapy, or those who take oral contraceptives.
(6) Having bleeding in their mouth due to periodontal disease or other causes.
(7) Feeling that it is difficult to produce saliva due to xerostomia or other causes, and those whose oral moisture content was 27.9% or less as determined by an oral moisture meter test before the experiment.
Target sample size
480
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Fukuda |
Organization
National Institute of Advanced Industrial Science and Technology (AIST)
Division name
Sensing System Research Center
Zip code
305-8565
Address
1-1-1 Higashi, Tsukuba, Ibaraki
TEL
050-3521-1962
t-fukuda@aist.go.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Fukuda |
Organization
National Institute of Advanced Industrial Science and Technology (AIST)
Division name
Sensing System Research Center
Zip code
305-8565
Address
1-1-1 Higashi, Tsukuba, Ibaraki
TEL
050-3521-1962
Homepage URL
t-fukuda@aist.go.jp
Sponsor or person
Institute
National Institute of Advanced Industrial Science and Technology (AIST)
Institute
Department
Personal name
Funding Source
Organization
National Institute of Advanced Industrial Science and Technology (AIST)
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
National Institute of Advanced Industrial Science and Technology (AIST)
Address
1-1-1 Higashi, Tsukuba, Ibaraki
Tel
029-861-2120
safe-life-ml@aist.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
| 2026 | Year | 08 | Month | 28 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 09 | Month | 11 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 27 | Day |
Anticipated trial start date
| 2026 | Year | 08 | Month | 28 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2027 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 08 | Month | 28 | Day |
Last modified on
| 2026 | Year | 08 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071817
