The effect of romosozumab on bone mineral density depending on prior treatment: a prospective, multicentre cohort study in Switzerland.

This multicentre, prospective cohort study measured the effect of romosozumab for 12 months on bone mineral density, taking into account prior therapies. Prior antiresorptive therapy blunted the BMD response to romosozumab, and the duration was correlated with BMD changes at both the lumbar spine and total hip. INTRODUCTION: In Switzerland, romosozumab is administered to high-risk osteoporosis patients. Our study aimed to assess the effect of romosozumab on bone mineral density (BMD), taking into account prior therapies. METHODS: This multicentre, prospective cohort study measured the effect of romosozumab for 12 months in patients in a nationwide Swiss osteoporosis registry. BMD and bone turnover marker (P1NP and CTX) changes were measured and compared between pre-treated and treatment naïve patients. RESULTS: Ninety-nine patients (92 women and 7 men, median age 71 years [65, 76]) were enrolled from January 2021 to December 2023. Among them, 22 had no prior treatment before romosozumab, while 77 had previous therapy (including 23 with a history of prior teriparatide therapy), with a median duration of 6 years [4, 11] of cumulative antiresorptive treatment. Over 12 months, romosozumab led to BMD changes of 10.3% [7.5, 15.5] at the lumbar spine, 3.1% [1.1, 5.8] at the total hip and 3.1% [0.5, 5.3] at the femoral neck, indicating notable variability. Significantly lower BMD responses were observed in pre-treated patients, with the duration of prior antiresorptive therapy inversely associated with BMD increases at the lumbar spine and hip. Other predictors of BMD changes at the total hip included baseline T-scores at the hip, body mass index and baseline CTX level, while the BMD response at the lumbar spine was associated with the lumbar spine T-score at baseline, age and baseline CTX level. CONCLUSION: Prior antiresorptive therapy blunted the BMD response to romosozumab, and the duration was correlated with BMD changes at both the lumbar spine and total hip.

Mobile phone specific radiation disturbs cytokinesis and causes cell death but not acute chromosomal damage in buccal cells: Results of a controlled human intervention study.

Several human studies indicate that mobile phone specific electromagnetic fields may cause cancer in humans but the underlying molecular mechanisms are currently not known. Studies concerning chromosomal damage (which is causally related to cancer induction) are controversial and those addressing this issue in mobile phone users are based on the use of questionnaires to assess the exposure. We realized the first human intervention trial in which chromosomal damage and acute toxic effects were studied under controlled conditions. The participants were exposed via headsets at one randomly assigned side of the head to low and high doses of a UMTS signal (n = 20, to 0.1 W/kg and n = 21 to 1.6 W/kg Specific Absorption Rate) for 2 h on 5 consecutive days. Before and three weeks after the exposure, buccal cells were collected from both cheeks and micronuclei (MN, which are formed as a consequence of structural and numerical chromosomal aberrations) and other nuclear anomalies reflecting mitotic disturbance and acute cytotoxic effects were scored. We found no evidence for induction of MN and of nuclear buds which are caused by gene amplifications, but a significant increase of binucleated cells which are formed as a consequence of disturbed cell divisions, and of karyolitic cells, which are indicative for cell death. No such effects were seen in cells from the less exposed side. Our findings indicate that mobile phone specific high frequency electromagnetic fields do not cause acute chromosomal damage in oral mucosa cells under the present experimental conditions. However, we found clear evidence for disturbance of the cell cycle and cytotoxicity. These effects may play a causal role in the induction of adverse long term health effects in humans.

Numerical assessment of induced electric fields in a worker's hand with commonly used metallic implants under exposure to low frequency magnetic fields.

The European Union's Workers' Directive 2013/35/EU on the minimum health and safety requirements regarding the exposure of workers to electromagnetic fields specifies action levels (ALs) for external electric and magnetic fields, which should protect against induced tissue-internal electric field strengthEiabove the exposure limit values, the latter being defined in order to prevent tissue stimulation at low frequencies. However, although 2013/35/EU explicitly calls for the protection of 'workers at particular risk' (including workers with metallic implants), the AL specified in the Directive have been derived under the assumption that there are no metallic parts present inside the body. Therefore, in the present work, we analysed the situation of a worker's hand and forearm bearing metallic implants (Herbert screw and volar radius plate) used for osteosynthesis after the most common bone fractures of the hand/forearm, exposed to low frequency magnetic fields. The uniform exposure of the whole hand and forearm as well as the exposure to a specific and widely used device, a deactivator for single-use labels of acousto-magnetic electronic article surveillance systems, were considered based on numerical computations using a high-resolution anatomical hand and forearm model. The results obtained indicated that the maximum induced electric field strength averaged in a volume of 2 mm × 2 mm × 2 mm cube was higher in the presence of the metallic implants by a factor of up to 4.2 for bone tissue and 2.3 for soft tissue compared with the case without an implant. Hence, it is obvious that the local induced electric field strengths may be substantially increased by the implants. The extent of this increase, however, is highly dependent on the implant's position inside the body, the implant's geometry, and the field distribution and orientation with respect to the anatomical structure and the implant.

Nonsinusoidalin situelectric field caused by magnetic deactivator device for EAS labels-assessment of field strength inside a detailed anatomical hand model.

In order to evaluate the localised magnetic field (MF) exposure of the cashier's hand due to a particular demagnetization device (deactivator) for single-use labels of an acoustomagnetic (AM) electronic article surveillance (EAS) system, comprehensive measurements of the MF near the surface of the deactivator, and numerical computations of the induced electric field strengthEi, were performed in high-resolution anatomical hand models of different postures and positions with respect to the deactivator. The measurement results for magnetic inductionBwere assessed with respect to the action levels (AL) for limb exposure, and the computational results forEiwere evaluated with respect to the exposure limit values (ELV) for health effects according to European Union (EU) directive 2013/35/EU. For the ELV-based assessment, a maximum of the 2 × 2 × 2 mm3averagedEi(maxEi,avg) and the respective 99.9th, 99.5th, and 99.0th percentiles were used. As the MF impulse emitted by the deactivator for demagnetization of the AM-EAS labels was highly nonsinusoidal, measurement results were assessed based on the weighted peak method in the time domain (WPM-TD). A newly developed scaling technique was proposed to also apply the WPM-TD to the assessment of the (nonsinusoidal)Eiregarding the ELV. It was used to calculate the resulting WPM-TD-based exposure index (EI) from frequency domain computations. The assessment regarding the AL for limbs yielded peak values of magnetic induction of up to 97 mT (measured with a 3 cm2MF probe on top of the deactivator surface) corresponding to an EI of 443%. However, this was considered an overestimation of the actual exposure in terms ofEias the AL were intentionally defined conservatively. A WPM-TD-based assessment ofEifinally led to the worst case EI of up to 135%, 93%, 78%, and 72% when using the maxEi,avg, 99.9th, 99.5th, and 99.0th percentiles, respectively.

Design and Dosimetric Characterization of a Broadband Exposure Facility for In Vitro Experiments in the Frequency Range 18-40.5 GHz.

A novel exposure facility for exposing cell monolayers to centimeter and millimeter waves (18-40.5 GHz) used by future 5G mobile communication technology and similar applications has been developed. A detailed dosimetric characterization of the apparatus for frequencies of 27 and 40.5 GHz and 60 mm petri dishes, used in a presently ongoing study on human dermal fibroblasts and keratinocytes, was carried out. The exposure facility enables a well-defined, randomized, and blinded application of sham exposure and exposure with selectable values of incident power flux density, and additionally provides the possibility of continuous monitoring of the sample temperature during exposure while it does not require significant deviations from routine in vitro handling procedures, i.e. petri dishes are not required to be placed inside waveguides or TEM cells. Mean specific absorption rate (SAR) values inside the cell monolayer of 115 W/kg (27 GHz) and 160 W/kg (40.5 GHz) per watt antenna input power and corresponding transmitted power density (St ) values at the bottom of the cell monolayer of 65 W/m2 (27 GHz) and 70 W/m2 (40.5 GHz) per watt antenna input power can be achieved, respectively. For reasonable amounts of harvested cells (80% of petri dish bottom area), the variation (max/min) of SAR and St over the cell monolayer remains below 3.7 dB (27 GHz) and 3.0 dB (40.5 GHz), respectively. © 2021 Bioelectromagnetics Society.

Effects of 2.45 GHz Wi-Fi exposure on sleep-dependent memory consolidation.

Studies have reported that exposure to radiofrequency electromagnetic fields (RF-EMF) emitted by mobile telephony might affect specific sleep features. Possible effects of RF-EMF emitted by Wi-Fi networks on sleep-dependent memory consolidation processes have not been investigated so far. The present study explored the impact of an all-night Wi-Fi (2.45 GHz) exposure on sleep-dependent memory consolidation and its associated physiological correlates. Thirty young males (mean ± standard deviation [SD]: 24.1 ± 2.9 years) participated in this double-blind, randomized, sham-controlled crossover study. Participants spent five nights in the laboratory. The first night was an adaptation/screening night. The second and fourth nights were baseline nights, each followed consecutively by an experimental night with either Wi-Fi (maximum: psSAR10g = <25 mW/kg; 6 min average: <6.4 mW/kg) or sham exposure. Declarative, emotional and procedural memory performances were measured using a word pair, a sequential finger tapping and a face recognition task, respectively. Furthermore, learning-associated brain activity parameters (power spectra for slow oscillations and in the spindle frequency range) were analysed. Although emotional and procedural memory were not affected by RF-EMF exposure, overnight improvement in the declarative task was significantly better in the Wi-Fi condition. However, none of the post-learning sleep-specific parameters was affected by exposure. Thus, the significant effect of Wi-Fi exposure on declarative memory observed at the behavioural level was not supported by results at the physiological level. Due to these inconsistencies, this result could also be a random finding.

RF-EMF exposure effects on sleep - Age doesn't matter in men!

BACKGROUND: Although there are several human experimental studies on short-term effects of radiofrequency electromagnetic fields (RF-EMF) on sleep, the role of effect modification by sex or age in this context has not yet been considered. In an earlier study, we observed sex differences in RF-EMF effects in elderly subjects. The present study investigated possible RF-EMF effect modifications by age in men. METHODS: Data available for the present analysis come from three double-blind, randomized cross-over studies, in which effects of different RF-EMF exposure signals on sleep were investigated in young [sample 1: 25.3 (mean) ± 2.6 (SD) years; sample 2: 25.4 ± 2.6 years; n = 30, respectively] and older (69.1 ± 5.5 years; n = 30) healthy male volunteers. Studies comprised a screening/adaptation night followed by nine experimental nights at two-week intervals. RF-EMF exposure effect modifications by age were analysed for two different exposure signals (GSM900 at 2 W/kg, TETRA at 6 W/kg), each compared to a sham exposure. Polysomnography, during which the exposure signals were delivered by a head worn antenna, as well as sleep staging were performed according to the AASM standard. Four subjective and 30 objective sleep parameters were statistically analysed related to possible RF-EMF effects. RESULTS: Comparisons of sleep parameters observed under sham exposure revealed highly pronounced physiological differences between young and elderly men. A consistent exposure effect in both age groups was found for a shorter latency to persistent sleep under TETRA exposure reflecting a sleep-promoting effect. Exposure effect modifications by age were observed for two of the four self-reported sleep parameters following GSM900 exposure and for arousals during REM sleep under TETRA exposure. CONCLUSIONS: As effects of a short-term all-night RF-EMF exposure on sleep occurred only sporadically in young and elderly men, it seems that age doesn't matter in this respect. However, as long as there are no corresponding data from young healthy women that would allow a comparison with the data from elderly women, this assumption cannot be conclusively verified. Nevertheless, the present results are not indicative of any adverse health effects.

An experimental study on effects of radiofrequency electromagnetic fields on sleep in healthy elderly males and females: Gender matters!

BACKGROUND: Results from human experimental studies investigating possible effects of radiofrequency electromagnetic fields (RF-EMF) on sleep are heterogeneous. So far, there is no study on possible sex-differences in RF-EMF effects. OBJECTIVES: The present study aimed at analyzing differences in RF-EMF effects on the macrostructure of sleep between healthy elderly males and females. METHODS: With a double-blind, randomized, sham-controlled cross-over design effects of two RF-EMF exposures (GSM900 and TETRA) on sleep were investigated in samples of 30 elderly healthy male and 30 healthy elderly female volunteers. Participants underwent each of the three exposure conditions on three occassions following an individually randomized order resulting in a total of nine study nights per participant. Exposure was delivered for 30 min prior to sleep and for the whole night (7.5 h) by a head worn antenna specifically designed for the projects. The peak spatial absorption rate averaged over time in head tissues (psSAR10g) was 6 W/kg for TETRA and 2 W/kg for GSM900. Thirty variables characterising the macrostructure of sleep and arousals as well as four subjective sleep variables were considered for statistical analyses. RESULTS: Multivariate analyses revealed that exposure to GSM900 and/or TETRA resulted in a significant reduction in arousals, a shorter latency to sleep stage N3, and a shorter self-reported time awake after sleep in both males and females. Exposure effects depending on sex (significant interactions) were observed. Latency to sleep stage R was shorter in females and tended to be longer in males under both exposures. Latency to stage N3 was shorter in females under TETRA exposure and almost not affected in males. The time awake within the sleep period under TETRA exposure was shorter in females and only slightly longer in males. Under GSM exposure, the self-rated total sleep time tended to be longer in females and to be shorter in males. Finally, the number of awakenings was lower only in females and tended to be higher in males under GSM exposure. DISCUSSION: With regard to RF-EMF effects on human sleep it seems that gender matters since GSM900 and TETRA led to significantly more exposure effects in females. Regardless of gender, none of the observed changes is indicative of a sleep disturbing effect of RF-EMF exposure. Observed effects might be mediated by skin related thermoregulatory mechanisms.

Design and Dosimetric Analysis of an Exposure Facility for Investigating Possible Effects of 2.45 GHz Wi-Fi Signals on Human Sleep.

A new head exposure system for double-blind provocation studies investigating possible effects of 2.45 GHz Wi-Fi exposure on human sleep was developed and dosimetrically analyzed. The exposure system includes six simultaneously radiating directional antennas arranged along a circle (radius 0.6 m) around the test subject's head, and enables a virtually uniform head exposure, i.e. without any preferred direction of incidence, during sleep. The system is fully computer-controlled and applies a real wireless local area network (WLAN) signal representing different transmission patterns as expected in real WLAN scenarios, i.e. phases of "beacon only" as well as phases of different data transmission rates. Sham and verum are applied in a double-blind crossover study design and all relevant exposure data, i.e. forward and reverse power at all six antenna inputs, are continuously recorded for quality control. For a total antenna input power (sum of all antennas) of 220 mW, typical specific absorption rate (SAR) in cortical brain regions is approximately 1-2 mW/kg (mass average SAR over respective brain region), which can be seen as a realistic worst-case exposure level in real WLAN scenarios. Taking into account variations of head positions during the experiments, the resulting exposure of different brain regions may deviate from the given average SAR levels up to 10 dB. Peak spatial 10 g average SAR in all brain and all head tissues is between 1.5-3.5 and 10.4-25 mW/kg, respectively. Bioelectromagnetics. © 2020 Bioelectromagnetics Society.

Dosimetric analysis of hands exposure during handling of strong permanent magnets.

Workers in a production line for synchronous motors occasionally reported tingling sensations or a feeling of numbness in their hands when handling strong permanent magnets. As the magnetic flux density (B) and its gradients along and close to the surface of the permanent magnets were expected to be comparably high and the movements of the workers' hands may therefore cause relevant induction inside the tissue, a detailed dosimetric analysis of the in situ electric field inside the hands (Ei) of the workers was carried out. The time derivate of the magnetic flux density (dB/dt) occurring along the hands was determined based on time domain measurements using a specially developed 'measurement glove' containing 12 Hall sensors. Based on these measurement results temporal peak electric field strength (Ei) induced inside a newly developed high resolution anatomical hand models were numerically computed, using the scalar potential finite difference (SPFD) method. The highest measured dB/dt along the palmar side of the hand was 51.2 T s-1. The corresponding worst case temporal peak value of the maximum of the Ei averaged over 2 × 2 × 2 mm3 in soft tissue was 2.0 V m-1, which is a factor of 1.8 higher than the applicable exposure limit value, but still below the range of 3.8-6.2 V m-1 which is presently assumed the range of lowest stimulation threshold for peripheral nerves. Our analysis did therefore not provide an indication that the perception reported by the workers are due to tissue stimulation in the sense of provoking action potentials.

Benchmark of different assessment methods for non-sinusoidal magnetic field exposure in the context of European Directive 2013/35/EU.

For the assessment of non-sinusoidal magnetic fields the European EMF Directive 2013/35/EU specified the Weighted Peak Method in Time Domain (WPM-TD) as the reference method. However, also other scientifically validated methods are allowed, provided that they lead to approximately equivalent and comparable results. In the non-binding guide for practical implementation of 2013/35/EU three methods alternative to the WPM-TD are described, i.e. the Weighted Peak Method in Frequency Domain (WPM-FD), the Multiple Frequency Rule (MFR), and an alternative Time Domain Assessment Method (TDAM). In this paper the results of a benchmark comparison of these assessment methods, based on 12 different time domain signals of magnetic induction, measured close to real devices and nine additional generic waveforms, are presented. The results demonstrated that assessments obtained with WPM-TD and WPM-FD can be considered approximately equivalent (maximum deviation 3.4 dB). The MFR systematically overestimates exposure, due to its inherently conservative definitions. In contrast, the TDAM significantly and systematically underestimates exposure up to a factor of 22 (26.8 dB) for the considered waveforms. The main reasons for this exposure underestimation by the TDAM are the introduction of an inappropriate time averaging, and the fact that the characteristic time parameter τ p,min, describing the minimum duration of all field changes dB/dt of the waveform is derived independently from the extent of the field change in the definitions of the TDAM. Consequently, we recommend not to use the TDAM as presently published in the non-binding guide to 2013/35/EU, as its application would be in contradiction with the underlying aim of 2013/35/EU, i.e. a harmonised level of occupational safety with respect to exposure to electromagnetic fields.

Dosimetric issues with simplified homogeneous body models in low frequency magnetic field exposure assessment.

A simplified procedure, using circular disk models with homogeneous electric conductivity as representations for different body parts, has been proposed recently by product standard IEC 62822-3 for the assessment of magnetic field exposure in proximity to current-carrying conductors of welding equipment. Based on such simplified models, worst case coupling coefficients CCEi(I), i.e. maximum induced electric field strength, normalised for current and frequency, for body parts at different distances d to straight single and double wire arrangements, as well as rectangular loop-shaped current paths are tabulated in the standard. In this work we compared CCEi(I) values obtained by numerical computations with detailed anatomical models of the hand/forearm with the corresponding values given in IEC 62822-3 for current-carrying single wire conductors along the forearm at distances d = 30, 50 and 100 mm, respectively. Our results clearly indicated that the CCEi(I) given in the standard may substantially underestimate the actual exposure. Using average values for tissue conductivities the observed extent of underestimation was up to 8.9 dB (factor 2.79) and may be even higher for worst case combinations of tissue conductivities. The reasons for this substantial underestimation are the oversimplified geometry, i.e. the circular disk does not reflect anatomical constrictions of the induction area present in realistic hand/forearm geometries, as well as the missing conductivity contrast between different tissues in the homogeneous disk models. Results of exposure assessment and corresponding minimum distances to components of welding equipment obtained by the simplified disk model approach suggested by IEC 62822-3 should therefore be considered with caution.

Inconsistency of a recently proposed method for assessing magnetic field exposure for protection against peripheral nerve stimulation in occupational situations.

A non-binding guide to practical implementation of European Directive 2013/35/EU concerning the limitation of occupational exposure against electromagnetic fields has been published recently. With regard to exposure assessment this guide proposes practically applicable assessment methods for non-uniform and non-sinusoidal environmental electric and magnetic fields, respectively. For non-sinusoidal magnetic fields in the low frequency range this guide proposes a time domain assessment (TDA) method, claimed to reduce the overestimation of exposure inherent to other assessment methods while being based on fundamental physiological principles regarding nerve stimulation. In the present paper we demonstrate that the proposed TDA method is not consistent with the obvious underlying principles of directive 2013/35/EU. Based on practically relevant waveforms and general considerations it can be shown that external magnetic fields may be deemed compliant by the TDA method although the underlying exposure limit values defined in 2013/35/EU may be exceeded. We therefore strongly recommend that the TDA method is removed from the guide for implementing 2013/35/EU as soon as possible.

Terrestrial Trunked Radio (TETRA) exposure and its impact on slow cortical potentials.

BACKGROUND: Studies have shown that exposure to radiofrequency electromagnetic fields (RF-EMF) in the mobile communication frequency range may induce physiological modifications of both spontaneous as well as event-related human electroencephalogram. So far, there are very few peer-reviewed studies on effects of Terrestrial Trunked Radio (TETRA), which is a digital radio communication standard used by security authorities and organizations in several European countries, on the central nervous system. OBJECTIVES: To analyze the impact of simulated TETRA handset signals at 385 MHz on slow cortical potentials (SCPs). METHODS: 30 young healthy males (25.2±2.7 years) were exposed in a double-blind, counterbalanced, cross-over design to one of three exposure levels (TETRA with 10 g averaged peak spatial SAR: 1.5 W/kg, 6.0 W/kg and sham). Exposure was conducted with a body worn antenna (especially designed for this study), positioned at the left side of the head. Subjects had 9 test sessions (three per exposure condition) in which three SCPs were assessed: SCP related to a clock monitoring task (CMT), Contingent negative variation (CNV) and Bereitschaftspotential (BP). RESULTS: Neither behavioral measures nor the electrophysiological activity was significantly affected by exposure in the three investigated SCP paradigms. Independent of exposure, significant amplitude differences between scalp regions could be observed for the CMT-related SCP and for the CNV. CONCLUSIONS: The present results reveal no evidence of RF-EMF exposure-dependent brain activity modifications investigated at the behavioral and the physiological level.

Do signals of a hand-held TETRA transmitter affect cognitive performance, well-being, mood or somatic complaints in healthy young men? Results of a randomized double-blind cross-over provocation study.

BACKGROUND: TETRA (terrestrial trunked radio) is a digital radio communication standard, which has been implemented in several European countries and is used by public executives, transportation services, and by private companies. Studies on possible impacts on the users' health considering different exposure conditions are missing. OBJECTIVES: To investigate possible acute effects of electromagnetic fields (EMF) of two different levels of TETRA hand-held transmitter signals on cognitive function and well-being in healthy young males. METHODS: In the present double-blind cross-over study possible effects of short-term (2.5h) EMF exposure of handset-like signals of TETRA (385 MHz) were studied in 30 healthy male participants (mean±SD: 25.4±2.6 years). Individuals were tested on nine study days, on which they were exposed to three different exposure conditions (Sham, TETRA 1.5 W/kg and TETRA 6.0 W/kg) in a randomly assigned and balanced order. Participants were tested in the afternoon at a fixed timeframe. RESULTS: Attention remained unchanged in two out of three tasks. In the working memory significant changes were observed in two out of four subtasks. Significant results were found in 5 out of 35 tested parameters, four of them led to an improvement in performance. Mood, well-being and subjective somatic complaints were not affected by TETRA exposure. CONCLUSIONS: The results of the present study do not indicate a negative impact of a short-term EMF-effect of TETRA on cognitive function and well-being in healthy young men.

The discrepancy between maximum in vitro exposure levels and realistic conservative exposure levels of mobile phones operating at 900/1800 MHz.

The objective of this paper is to compare realistic maximum electromagnetic exposure of human tissues generated by mobile phones with electromagnetic exposures applied during in vitro experiments to assess potentially adverse effects of electromagnetic exposure in the radiofrequency range. We reviewed 80 in vitro studies published between 2002 and present that concern possible adverse effects of exposure to mobile phones operating in the 900 and 1800 MHz bands. We found that the highest exposure level averaged over the cell medium that includes evaluated cells (monolayer or suspension) used in 51 of the 80 studies corresponds to 2 W/kg or less, a level below the limit defined for the general public. That does not take into account any exposure non-uniformity. For comparison, we estimated, by numerical means using dipoles and a commercial mobile phone model, the maximum conservative exposure of superficial tissues from sources operated in the 900 and 1800 MHz bands. The analysis demonstrated that exposure of skin, blood, and muscle tissues may well exceed 40 W/kg at the cell level. Consequently, in vitro studies reporting minimal or no effects in response to maximum exposure of 2 W/kg or less averaged over the cell media, which includes the cells, may be of only limited value for analyzing risk from realistic mobile phone exposure. We, therefore, recommend future in vitro experiments use specific absorption rate levels that reflect maximum exposures and that additional temperature control groups be included to account for sample heating.

Experimental investigation of possible warmth perception from a head exposure system for human provocation studies with TETRA handset-like signals.

An experimental investigation of warming and warmth perception caused by handset EMF exposure was performed in order to examine its possible impact on blinding. Healthy male participants (15) were exposed to three different exposure conditions: sham and Terrestrial Trunked Radio (TETRA) handsets with maximum 10 g averaged SAR values of 1.5 and 6 W/kg each on three days. The study followed a randomized, double-blind design. TETRA signals simulated exposure from a handheld device consisting of a 385 MHz carrier modulated with a pulse length of 14.17 ms and a pulse period of 56.67 ms (i.e., duty cycle 25%; 17.65 Hz pulse modulation). A body worn antenna was used and fixed at the left ear. In addition to subjective ratings, skin temperatures at two locations close to the radiating element of the body-worn antenna were measured. The measurements revealed a temperature rise proportional to the supplied RF power with an average temperature increase measured at the two locations of 0.8 °C following the high exposure level of 6 W/kg. However, subjects were not able to distinguish between exposure conditions based on their subjective perception and thus the double-blinding was ensured.

Design and dosimetric analysis of a 385 MHz TETRA head exposure system for use in human provocation studies.

A new head exposure system for double-blind provocation studies investigating possible effects of terrestrial trunked radio (TETRA)-like exposure (385 MHz) on central nervous processes was developed and dosimetrically analyzed. The exposure system allows localized exposure in the temporal brain, similar to the case of operating a TETRA handset at the ear. The system and antenna concept enables exposure during wake and sleep states while an electroencephalogram (EEG) is recorded. The dosimetric assessment and uncertainty analysis yield high efficiency of 14 W/kg per Watt of accepted antenna input power due to an optimized antenna directly worn on the subject's head. Beside sham exposure, high and low exposure at 6 and 1.5 W/kg (in terms of maxSAR10g in the head) were implemented. Double-blind control and monitoring of exposure is enabled by easy-to-use control software. Exposure uncertainty was rigorously evaluated using finite-difference time-domain (FDTD)-based computations, taking into account anatomical differences of the head, the physiological range of the dielectric tissue properties including effects of sweating on the antenna, possible influences of the EEG electrodes and cables, variations in antenna input reflection coefficients, and effects on the specific absorption rate (SAR) distribution due to unavoidable small variations in the antenna position. This analysis yielded a reasonable uncertainty of <±45% (max to min ratio of 4.2 dB) in terms of maxSAR10g in the head and a variability of <±60% (max to min ratio of 6 dB) in terms of mass-averaged SAR in different brain regions, as demonstrated by a brain region-specific absorption analysis.

Measurement and image-based estimation of dielectric properties of biological tissues -past, present, and future.

The dielectric properties of biological tissues are fundamental pararmeters that are essential for electromagnetic modeling of the human body. The primary database of dielectric properties compiled in 1996 on the basis of dielectric measurements at frequencies from 10 Hz to 20 GHz has attracted considerable attention in the research field of human protection from non-ionizing radiation. This review summarizes findings on the dielectric properties of biological tissues at frequencies up to 1 THz since the database was developed. Although the 1996 database covered general (normal) tissues, this review also covers malignant tissues that are of interest in the research field of medical applications. An intercomparison of dielectric properties based on reported data is presented for several tissue types. Dielectric properties derived from image-based estimation techniques developed as a result of recent advances in dielectric measurement are also included. Finally, research essential for future advances in human body modeling is discussed.

The effect of radiofrequency electromagnetic fields (RF-EMF) on biomarkers of oxidative stress in vivo and in vitro: A protocol for a systematic review.

BACKGROUND: Oxidative stress is conjectured to be related to many diseases. Furthermore, it is hypothesized that radiofrequency fields may induce oxidative stress in various cell types and thereby compromise human and animal health. This systematic review (SR) aims to summarize and evaluate the literature related to this hypothesis. OBJECTIVES: The main objective of this SR is to evaluate the associations between the exposure to radiofrequency electromagnetic fields and oxidative stress in experimental models (in vivo and in vitro). METHODS: The SR framework has been developed following the guidelines established in the WHO Handbook for Guideline Development and the Handbook for Conducting a Literature-Based Health Assessment). We will include controlled in vivo and in vitro laboratory studies that assess the effects of an exposure to RF-EMF on valid markers for oxidative stress compared to no or sham exposure. The protocol is registered in PROSPERO. We will search the following databases: PubMed, Embase, Web of Science Core Collection, Scopus, and the EMF-Portal. The reference lists of included studies and retrieved review articles will also be manually searched. STUDY APPRAISAL AND SYNTHESIS METHOD: Data will be extracted according to a pre-defined set of forms developed in the DistillerSR online software and synthesized in a meta-analysis when studies are judged sufficiently similar to be combined. If a meta-analysis is not possible, we will describe the effects of the exposure in a narrative way. RISK OF BIAS: The risk of bias will be assessed with the NTP/OHAT risk of bias rating tool for human and animal studies. We will use GRADE to assess the certainty of the conclusions (high, moderate, low, or inadequate) regarding the association between radiofrequency electromagnetic fields and oxidative stress. FUNDING: This work was funded by the World Health Organization (WHO). REGISTRATION: The protocol was registered on the PROSPERO webpage on July 8, 2021.