Investigation of Possible Effects of a Lifestyle Product in a Double-blind Pre-Post-Between-Groups Study

Within this study, the Lifestyle product Qi-Shield manufactured by Waveguard GmbH shall be investigated regarding its subjective psychological and neurophysiological effects. Thereby, the constructs well-being, stress feeling in the everyday life and subjectively perceived sleep quality as well as (neuro)-physiological correlates are of particular interest. The physical effects of the product will not be scope of this study. According to the World Health Organization (WHO), the number and variety of sources of electromagnetic fields (EMF) has increased over the last decades. These sources include video display units (VDUs) associated with computers, cell phones and their base stations, which does not exclude possible health risks from EMF emissions. In this context, several studies report a variety of health problems associated with exposure to EMFs. The sensitivity to EMF is called electromagnetic hypersensitivity. EHS is characterized by a variety of non-specific effects that people attribute to exposure to EMFs. Among the most frequently reported effects are dermatological symptoms and neurasthenic and vegetative symptoms. Some laboratory studies explored the relationship between EMF (short-term exposure) and EHS and observed highly inter-subjectively varying effects. However, EHS has no clear diagnostic criteria and there is no scientific basis to link EHS effects to EMF exposure, at least not to short-term EMF exposure. However, the limited quantity and quality of research on possible effects of EMF does not allow excluding long-term effects.

The Qi-Shield device aims to reduce effects of EMF exposure and enable to maintain subjective well-being, low stress perception and good sleep quality.

Previous literature reported neuronal correlates characterized with (acute) stress exposure and effects on well-being (especially emotional regulation) at the physiological (autonomic nervous system) and neurophysiological level (central nervous system). These measurements can also be observed during the resting state. On a physiological level, heart rate variability (HRV) -recorded by the electrocardiography (ECG) - can be derived as a constant measure of the influence of stress. The most frequently reported parameter under acute stress was low parasympathetic activity, characterized by a decrease in the high frequency band (0.15-0.4 Hz, HF) and an increase in the low frequency band (0.04-0.15 Hz, LF). Furthermore, the measurement of sweat production of the skin - recorded by the derivation of the electrodermal skin activity (EDA) - is suitable to characterize specific influences on the autonomic nervous system. For this purpose, the EDA signal can be segmented into phasic reactions (individual rapid reactions - usually responses to a given stimulus) and tonic components (longer lasting basic skin resistance value). From these two components, the number of individual phasic responses, the summed amplitude of the phasic responses, and the change in the tonic state of the electrical conductivity are the most suitable feature to investigate effects of stress on the physiological level. On a neurophysiological level, acute stress leads to effects in the resting state networks of the brain. A recently published study showed that acute stress weakens the connectivity of the front-parietal module and strengthens the connectivity of the module in the default mode network. Thus, it can be assumed that stress influences the information flow in networks that are important for salience processing (especially attention control) and self-referential mental processing or even emotional processing. Possible quantitative markers from EEG resting state measurements are the derivation of the frequency spectrum (derived by calculating the Fourier transform) as well as connectivity measures (calculating coherence measures from the EEG frequency spectrum). In particular, the ratio of frontal theta (4-7 Hz) to beta (13-30 Hz) activity can be derived from the resting EEG as an indicator of possible influences on cognitive control abilities (attention-control). Possible influences on one's own well-being, such as the ability to control one's emotions (impulse control), can be observed in changes in frontal alpha (8-14 Hz) activity both in frequency spectrum and coherence and in the determination of so-called frontal alpha asymmetry. Since there could be possible effects of Qi-shield may result in a reduction of EMF, power and coherence measures in individual alpha and beta band resting activity already observed in connection with EMF exposure may serve as a basis for this study. Regarding subjective influences on effects of the here studied device, various studies reported correlations between personality characteristics (i.e, critical thinking), fluid intelligence and the tendency towards and openness for paranormal beliefs. Matrix intelligence tests such as the Vienna Matrix Test 2 (WMT-2) detect inferential thinking and correlate strongly positively with manifestations in critical thinking. Both constructs show a negative correlation between manifestations of paranormal beliefs and statements about paranormal experiences. An influence of personality factors such as openness to new experiences can also be assumed. To control possible moderating or mediating factors, these constructs will be investigate, too.

The study design is a double-blind Pre-Post Between-Subject Design. This means that the subjects are invited twice (pre-session and post-session). Between the two sessions, there is one week of exposure time during which the subjects of the invention groups take the device home.

At the beginning of the experiment in the pre-session, all subjects (N=90) are checked for the presence of inclusion and exclusion criteria and if necessary excluded from the study. The subjects are assigned to the trial groups in a semi-randomized latin-square counterbalanced manner. The assignment is double-blind, i.e. neither the volunteer nor the investigator is informed which group receives a placebo or real intervention. The real devices resemble the sham devices in appearance, composition and weight, so that a traceability based on these factors is not possible. The products are marked with the letters A and B. The assignment which letter belongs to which intervention group is explained in a sealed envelope and will be opened after completion of the study and analysis. Prior to the start of the study, participants are informed about their rights and potential risk of participation with an authorized deception in case of the assumed effects of the intervention and asked to sign the declaration of consent in line with the declaration of Helsinki. The information for the intervention groups differs from the information for the no-intervention group, as the latter serves as a control group and therefore does not receive any information about the intervention.