Ignite Creation Date:
2024-05-06 @ 3:15 PM
Last Modification Date:
2024-10-26 @ 1:46 PM
Study NCT ID:
NCT04571775
Status:
UNKNOWN
Last Update Posted:
2020-10-09
First Post:
2020-09-14
Brief Title:
Effects of a Lifestyle Product on Physiological Measures and Subjective Well-being in Humans A Systematic Study
Sponsor:
Waveguard GmbH
Organization:
Waveguard GmbH
Study Overview
Official Title:
Investigation of Possible Effects of a Lifestyle Product in a Double-blind Pre-Post-Between-Groups Study
Status:
UNKNOWN
Status Verified Date:
2020-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Research question The study investigates possible effects of the lifestyle product Qi-Shield on a subjective and neuro-physiological level Thereby effects on well-being stress perception and the sleep quality as well as influencing factors like personality and beliefs are of particular interest
Sample and Design In the study 90 test persons are to be tested in a double-blind pre-post between-subject design with three groups real device A - sham device without effectiveness also called placebo B - no device C
Measurement methods Established questionnaires and scales as well as neuro-physiological methods comprising electroencephalography EEG electrocardiogram ECG and skin conductance level measure electrodermal activity EDA during a 20 mins resting state measure with alternating eyes open and closed are used
Statistical evaluation Group comparisons A B C in the difference between the measurement points post - pre on a subjective and neuro-physiological level
Sample and Design In the study 90 test persons are to be tested in a double-blind pre-post between-subject design with three groups real device A - sham device without effectiveness also called placebo B - no device C
Measurement methods Established questionnaires and scales as well as neuro-physiological methods comprising electroencephalography EEG electrocardiogram ECG and skin conductance level measure electrodermal activity EDA during a 20 mins resting state measure with alternating eyes open and closed are used
Statistical evaluation Group comparisons A B C in the difference between the measurement points post - pre on a subjective and neuro-physiological level
Detailed Description:
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 015-04 Hz HF and an increase in the low frequency band 004-015 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 ones own well-being such as the ability to control ones 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 ie 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 N90 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 ie 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
Afterwards the test person is asked to answer a control item for the examined product only for group A - correct product and B - sham product and then fill in questionnaires about sleep quality and current fatigue in detail below Subsequently the sensors for EEG ECG and EDA are prepared and fixed to the head and body accordance with the corresponding guidelines After this preparation the resting state measurements of electrophysiological signals EEG ECG and EDA are recorded during relaxation In order to identify possible effects in the alpha band resting measurements are taken with eyes closed so-called eyes closed EC as well as with eyes open so-called eyes open EO according to a standardized procedure This consists of an alternating task 20 minutes in total in which the subjects are asked to alternately relax with eyes open and relax with eyes closed for 60 seconds each In the phase with open eyes the test persons are asked to fixate a crosshair on a screen The change between the phases is signalled by an acoustic tone
Afterwards the measurement equipment is removed from the head and body and the test person is asked to answer several questionnaires and scales in detail below
At the end of the session test persons from groups A and B receive the information on handling the device and the device with the respective label A or B During the seven days exposure period subjects are asked daily to answer questions about their current condition and special events via an online survey The subjects in groups A and B are also asked to answer two questions related to the handling of the product During the exposure period subjects are supervised via WhatsApp or E-mail from employees of the University of Stuttgart and Fraunhofer IAO A short standardized text will be used as a reminder to fill in the questionnaires if participants have not been completed by a certain time 6 pm The second session is similar to the first session in terms of the way the study is conducted At the beginning of the session the subjects are again given detailed written information about the study and asked to sign the declaration of consent for the second session Afterwards the participants are asked to fill in the daily questions about well-being everyday stress and special events as well as the questionnaires about sleep quality and current fatigue Afterwards we will conduct the neurophysiological measurement during the resting state as in the pre-session Afterwards the measurement sensors are removed from the head and body and the participant is asked to answer the questionnaires and scales At the end of the post-session the test persons will be informed in detailed and the deception will be dissolved The experimenter will answers further questions
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 015-04 Hz HF and an increase in the low frequency band 004-015 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 ones own well-being such as the ability to control ones 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 ie 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 N90 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 ie 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
Afterwards the test person is asked to answer a control item for the examined product only for group A - correct product and B - sham product and then fill in questionnaires about sleep quality and current fatigue in detail below Subsequently the sensors for EEG ECG and EDA are prepared and fixed to the head and body accordance with the corresponding guidelines After this preparation the resting state measurements of electrophysiological signals EEG ECG and EDA are recorded during relaxation In order to identify possible effects in the alpha band resting measurements are taken with eyes closed so-called eyes closed EC as well as with eyes open so-called eyes open EO according to a standardized procedure This consists of an alternating task 20 minutes in total in which the subjects are asked to alternately relax with eyes open and relax with eyes closed for 60 seconds each In the phase with open eyes the test persons are asked to fixate a crosshair on a screen The change between the phases is signalled by an acoustic tone
Afterwards the measurement equipment is removed from the head and body and the test person is asked to answer several questionnaires and scales in detail below
At the end of the session test persons from groups A and B receive the information on handling the device and the device with the respective label A or B During the seven days exposure period subjects are asked daily to answer questions about their current condition and special events via an online survey The subjects in groups A and B are also asked to answer two questions related to the handling of the product During the exposure period subjects are supervised via WhatsApp or E-mail from employees of the University of Stuttgart and Fraunhofer IAO A short standardized text will be used as a reminder to fill in the questionnaires if participants have not been completed by a certain time 6 pm The second session is similar to the first session in terms of the way the study is conducted At the beginning of the session the subjects are again given detailed written information about the study and asked to sign the declaration of consent for the second session Afterwards the participants are asked to fill in the daily questions about well-being everyday stress and special events as well as the questionnaires about sleep quality and current fatigue Afterwards we will conduct the neurophysiological measurement during the resting state as in the pre-session Afterwards the measurement sensors are removed from the head and body and the participant is asked to answer the questionnaires and scales At the end of the post-session the test persons will be informed in detailed and the deception will be dissolved The experimenter will answers further questions
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None