UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044873 |
|---|---|
| Receipt number | R000051252 |
| Scientific Title | Research of biological effects of exposure to quasi-millimeter wave/millimeter wave on human body |
| Date of disclosure of the study information | 2021/08/01 |
| Last modified on | 2022/05/08 14:58:18 |
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Basic information
Public title
Investigation of biological effects of the exposure to radio waves (5G:5th generation mobile communication system) on human body
Acronym
Investigation of biological effects of the exposure to radio waves (5G:5th generation mobile communication system) on human body
Scientific Title
Research of biological effects of exposure to quasi-millimeter wave/millimeter wave on human body
Scientific Title:Acronym
Research of biological effects of exposure to quasi-millimeter wave/millimeter wave on human body
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the biological effects of high frequency radio waves used in 5G in healthy adults between 20 and 80 years old
Basic objectives2
Others
Basic objectives -Others
To investigate the biological effects of high frequency radio waves used in 5G in healthy adults between 20 and 80 years old
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in temperature in human skin during local exposure to quasi-millimeter wave/millimeter-wave
Key secondary outcomes
Changes in skin blood flow, core temperature, heart rate, respiratory rate, and temperature perception in the human body during local exposure to quasi-millimeter wave/millimeter wave
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
A quasi-millimeter wave (around 30 GHz) is exposed to the skin of human forearm.
After a period of 15 minutes for wash out, the exposure is repeated with a different exposure intensity.
Eight intensities of exposure (0, 0.05, 0.5, 1, 1.5, 2, 2.5, 3 W of antenna input power) are set.
Two of these intensities are randomly selected per day, and the exposure is performed in four days.
Interventions/Control_2
A millimeter wave (around 60 GHz) is exposed to the skin of human forearm.
After a period of 15 minutes for wash out, the exposure is repeated with a different exposure intensity.
Six intensities of exposure (0, 0.05, 0.5, 1, 2, 3 W of antenna input power) are set.
Two of these intensities are randomly selected per day, and the exposure is performed in three days.
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
Subjects who are between 20 and 80 years old at the time of obtaining written consent.
Subjects who has received sufficient explanation of the purpose and content of the research, has agreed in writing.
Subjects who is judged as an appropriate candidate according to the questionnaire and the interview.
Key exclusion criteria
Subjects with health problems.
If any falsehood is found in the consent form or the information declared.
Subjects who is judged as an inappropriate candidate according to the questionnaire and the interview.
Subjects who is considered as an inappropriate candidate by experiment staffs.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Tatsuya |
| Middle name | |
| Last name | Ishitake |
Organization
Kurume University
Division name
Department of Environmental Medicine
Zip code
830-0011
Address
67 Asahi-Machi, Kurume, Fukuoka, 830-0011, Japan
TEL
0942-31-7552
tishitak@med.kurume-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Masuda |
Organization
Kurume University
Division name
Department of Environmental Medicine
Zip code
830-0011
Address
67 Asahi-Machi, Kurume, Fukuoka, 830-0011, Japan
TEL
0942-31-7552
Homepage URL
bdxmsdb@yahoo.co.jp
Sponsor or person
Institute
Kurume University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Internal Affairs and Communications
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Graduate School of Information Science and Technology,Hokkaido University
Department of Electrical and Electronic Engineering, Kitami Institute of Technology
Department of Electrical and Mechanical Engineering, Nagoya Institute of Technology
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kurume University
Address
67 Asahi-Machi, Kurume, Fukuoka, 830-0011, Japan
Tel
0942-65-3749
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
| 2021 | Year | 08 | Month | 01 | 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
70
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
Completed
Date of protocol fixation
| 2017 | Year | 12 | Month | 08 | Day |
Date of IRB
| 2017 | Year | 12 | Month | 08 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 06 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 07 | Month | 15 | Day |
Last modified on
| 2022 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051252
