UMIN-CTR Clinical Trial

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
Email	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
Email	bdxmsdb@yahoo.co.jp

Sponsor
Institute	Kurume University
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051252