UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058357 |
|---|---|
| Receipt number | R000066701 |
| Scientific Title | Study of biological stress responses to 28 GHz radio wave exposure used in 5G communication devices |
| Date of disclosure of the study information | 2025/08/25 |
| Last modified on | 2025/07/11 16:11:51 |
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Basic information
Public title
Research on biological stress responses to Extremely High Frequency radio wave exposure used in 5G communication devices
Acronym
Research on biological stress responses to radio wave exposure
Scientific Title
Study of biological stress responses to 28 GHz radio wave exposure used in 5G communication devices
Scientific Title:Acronym
Study of biological stress responses to 28 GHz radio wave exposure
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
5G and autonomous driving technologies have rapidly expanded, but safety assessments of newly used radio waves lag behind. Key international guidelines (WHO, ICNIRP, IEEE C95.1) still rely on outdated data and lack evidence for vulnerable populations or diverse conditions. As a result, global demand for updated knowledge is increasing.
We evaluated the biological effects of 28 GHz exposure used in 5G. This frequency is thought to cause faster thermal effects than lower-frequency neurostimulation. Our findings partially support current guidelines.
We developed analytical methods to assess stress biomarkers (glucocorticoids, catecholamines, oxidative stress markers). A positive control with infrared heating (UMIN000055969) showed biomarker changes when back skin temperature increased by 5 degrees C or more.
This study uses similar 28 GHz exposure intensity.We will measure cortisol/cortisone, catecholamines, and oxidative stress markers to evaluate the biological effects of 28 GHz exposure.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Assessment of alterations in biological parameters induced by electromagnetic wave exposure, including urinary cortisol, cortisone, catecholamines, oxidative stress markers.
Key secondary outcomes
Effects of electromagnetic wave exposure on skin temperature and blood flow.
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
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
28 GHz Exposure: Electromagnetic wave exposure at 28 GHz will be applied to the skin surface of the subject's back using a radio wave irradiation device for 30 to 40 minutes, until the increase in skin temperature reaches a steady state. The procedure will be repeated approximately three times, with an interval of at least one day between sessions.
Interventions/Control_2
Infrared Exposure: Infrared radiation will be applied to the skin surface of the participant's back using an infrared heater for 30 to 40 minutes, until the skin temperature reaches a steady state. This procedure will be conducted approximately three times, with at least one day between sessions.
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
| 20 | years-old | < |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
- The participant is in good health
- Written informed consent has been obtained from the participant
- Based on interviews regarding lifestyle and medical history, and through the screening process, the research team has determined that the participant is eligible to take part in the study
Key exclusion criteria
Individuals who
- are pregnant or may be pregnant
- are determined not to be in good health at the time of obtaining consent
- are found to have provided false information in the consent form or self-reported data
Individuals
- with a pacemaker
- for whom conducting the study procedures is judged to be difficult by the research team
- deemed unsuitable for participation in the study based on interviews regarding lifestyle and medical history, or during the screening process
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Akiko |
| Middle name | |
| Last name | Matsumoto |
Organization
Faculty of Medicine, Saga University
Division name
Department of Social and Environmental Medicine
Zip code
849-5401
Address
5-1-1 Nabeshima, Saga, Saga, Japan
TEL
0952-34-2289
matsumoa@cc.saga-u.ac.jp
Public contact
Name of contact person
| 1st name | Mikiko |
| Middle name | |
| Last name | Tokiya |
Organization
Faculty of Medicine, Saga University
Division name
Department of Social and Environmental Medicine
Zip code
849-5401
Address
5-1-1 Nabeshima, Saga, Saga, Japan
TEL
0952-34-2289
Homepage URL
sx4932@cc.saga-u.ac.jp
Sponsor or person
Institute
Saga University
Institute
Department
Personal name
Funding Source
Organization
Radio Environment Division, Radio Department, Telecommunications Bureau, 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
Kurume University
Nagoya Institute of Technology
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee, Faculty of Medicine, Saga University
Address
5-1-1 Nabeshima, Saga, Saga, Japan
Tel
0952-34-3329
medsosou1@mail.admin.saga-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
久留米大学医学部(福岡県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 08 | Month | 25 | 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
| 2025 | Year | 05 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 07 | Month | 08 | 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
| 2025 | Year | 07 | Month | 03 | Day |
Last modified on
| 2025 | Year | 07 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066701
