UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062850 |
|---|---|
| Receipt number | R000071950 |
| Scientific Title | Study on Thermophysiological Responses to Radiofrequency Electromagnetic Fields toward Beyond 5G |
| Date of disclosure of the study information | 2026/09/08 |
| Last modified on | 2026/09/08 19:36:11 |
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Basic information
Public title
Study on Thermophysiological Responses to Radiofrequency Electromagnetic Fields toward Beyond 5G
Acronym
Beyond 5G Thermophysiology Study
Scientific Title
Study on Thermophysiological Responses to Radiofrequency Electromagnetic Fields toward Beyond 5G
Scientific Title:Acronym
Beyond 5G Thermophysiology Study
Region
| Japan |
Condition
Condition
Healthy volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the effects of radiofrequency electromagnetic field exposure on the human body by locally exposing human skin to radiofrequency electromagnetic fields in frequency bands expected to be used for Beyond 5G and evaluating physiological responses, including skin temperature, blood flow, and thermal sensation, thereby providing scientific evidence for the development of safe communication technologies and safety standards.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in body temperature, skin temperature, skin blood flow, and thermal sensation associated with radiofrequency electromagnetic field exposure.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are 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
Sham exposure
Interventions/Control_2
Exposure at A
Interventions/Control_3
Exposure at 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
| 18 | years-old | <= |
Age-upper limit
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Individuals aged 18 to 79 years at the time of informed consent who are not currently enrolled in high school.
2. Individuals who provide written informed consent to participate in the study.
3. Individuals without severe diseases that interfere with daily activities. Individuals with common chronic diseases, such as hypertension, may be included if the condition is appropriately controlled under medical supervision and participation in the study is considered acceptable.
4. Individuals judged by the principal investigator to be eligible to participate based on an interview and assessment of lifestyle-related information.
Key exclusion criteria
1. Individuals who do not meet the above inclusion criteria.
2. Individuals found to have provided false information at the time of informed consent or during participation in the study.
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | HIROSHI |
| Middle name | |
| Last name | MASUDA |
Organization
Kurume University School of Medicine
Division name
Dept. of Environmental Medicine
Zip code
8300011
Address
67 Asahimach, Kurume, Fukuoka, Japan
TEL
0942-31-7552
bdxmsdb@kurume-u.ac.jp
Public contact
Name of contact person
| 1st name | HIROSHI |
| Middle name | |
| Last name | MASUDA |
Organization
Kurume University School of Medicine
Division name
Dept. of Environmental Medicine
Zip code
8300011
Address
67 Asahimachi, Kurume, Fukuoka, Japan
TEL
0942-31-7552
Homepage URL
bdxmsdb@kurume-u.ac.jp
Sponsor or person
Institute
Kurume University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Internal Affairs and Communications (MIC)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Kurume University
Address
67 Asahimachi, Kurume, Fukuoka, Japan
Tel
0942653749
i_rinri@kurume-u.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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 09 | Month | 08 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 09 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 09 | Month | 14 | Day |
Last follow-up date
| 2029 | 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
| 2026 | Year | 09 | Month | 08 | Day |
Last modified on
| 2026 | Year | 09 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071950
