Tokyo, Aug. 25 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058357) titled 'Research on biological stress responses to Extremely High Frequency radio wave exposure used in 5G communication devices' on Aug. 25.

Study Type: Interventional

Study Design: Basic Design - Cross-over Randomization - Non-randomized Blinding - Single blind -participants are blinded Control - Placebo

Primary Sponsor: Institute - Saga University

Condition: Condition - None Classification by malignancy - Others Genomic information - NO

Objective: 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 Key international guidelines (WHO, ICNIRP, IEEE C95.1) still rely on outdated data and lack evidence for vulnerable populations or diverse conditions.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

Intervention: 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.

Eligibility: Age-lower limit - 20 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 Size - 10

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 05 Month 27 Day Anticipated trial start date - 2025 Year 07 Month 08 Day Last follow-up date - 2026 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066701

Disclaimer: Curated by HT Syndication.