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Effects of a Lifestyle Product on Physiological Measures and Subjective Well-being in Humans: A Systematic Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04571775
Recruitment Status : Recruiting
First Posted : October 1, 2020
Last Update Posted : October 9, 2020
Sponsor:
Collaborator:
University of Stuttgart, Institute of Human Factors and Technology Management
Information provided by (Responsible Party):
Waveguard GmbH

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.


Condition or disease Intervention/treatment Phase
Healthy Lifestyle Device: Qi-Shield user group Device: Sham Qi-Shield user group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Official Title: Investigation of Possible Effects of a Lifestyle Product in a Double-blind Pre-Post-Between-Groups Study
Actual Study Start Date : October 3, 2020
Estimated Primary Completion Date : February 1, 2021
Estimated Study Completion Date : February 1, 2021

Arm Intervention/treatment
Active Comparator: Qi-Shield user group Device: Qi-Shield user group
real device Qi-Shield (treatment)

Sham Comparator: Sham Qi-Shield user group Device: Sham Qi-Shield user group
sham device (placebo)

No Intervention: No Qi-Shield device group



Primary Outcome Measures :
  1. Adapted Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: Change from Baseline Measure at the 1st day at 7 days ]
    The PSQI asks about sleep quality retrospectively. It asks about the frequency of sleep disturbing events, the estimation of sleep quality, the usual sleeping times, sleep latency and sleep duration, the intake of sleep medication, as well as daytime tiredness. A total of 18 items are used for quantitative evaluation and 7 components are assigned, each of which can assume a value range from 0 to 3. The total score results from the summation of the component scores and can vary from 0 to 21, whereby a higher value corresponds to a reduced sleep quality. There is an empirically determined cut-off value (from 5), which allows a division into "good" and "bad" sleepers. Lower values are associated with better sleep quality.

  2. WHO-5 [ Time Frame: Change from Baseline Measure at the 1st day at 7 days ]
    The WHO 5 Well-being Index is a short questionnaire of only five questions that measures well-being. Values from 0 to 5 can be entered for each question. By summing up the values for the answers, one obtains a total value, whereby a low total value corresponds to a low level of well-being. A value less than 13 should indicate a possible depression. Standard values and test quality criteria can be used for WHO-5. The processing time is less than one minute.

  3. State Trait Anxiety Inventory [ Time Frame: Change from Baseline Measure at the 1st day at 7 days ]
    The State Trait Anxiety Inventory is based on the distinction between anxiety as a state and anxiety as a characteristic. The two scales of the STAI, each with 20 items, serve to record fear as a state (state anxiety) and fear as a characteristic (trait anxiety). The answer format is a 4-point Likert-rating scale. Higher values indicate higher state or trait anxiety.

  4. Positive and Negative Affect Schedule , PANAS [ Time Frame: Change from Baseline Measure at the 1st day at 7 days ]
    The PANAS records the emotional state of mind. The questionnaire consists of 20 adjectives that describe different sensations and feelings. 20 adjectives describe the dimensions of positive (10) and negative affect (10). The PANAS is used in this study for two temporal dimensions - once for an immediate assessment and further for a period of one week. The answer format is a 5-point Likert-rating scale (1 = "not at all" and 5 = " extremely").

  5. Adapted Perceived Stress Scale [ Time Frame: Change from Baseline Measure at the 1st day at 7 days ]
    The scale of perceived stress asks for subjectively experienced stress retrospectively. The 10 items were validated on a German sample and are a reliable, valid and economic instrument for the assessment of perceived stress. The answer format is a 7-point Likert-rating scale (1 = " not at all" and 7 = "completely"). Higher values are related to more stress perception.

  6. Brief Resilience Scale [ Time Frame: Change from Baseline Measure at the 1st day at 7 days ]
    The Brief Resilience Scale is a short, six-item measure of the ability to recover from stress on a five-point Likert scale. It showed good psychometric characteristics with high internal consistency and reliability in repeat tests.The items are rated on a five-point Likert scale (1 = strongly disagree, 2 = disagree, 3 = neutral, 4 = agree, 5 = strongly agree or 1 = stimme überhaupt nicht zu, 2 = stimme eher nicht zu, 3 = neutral, 4 = stimme eher zu, 5 = stimme vollkommen zu, respectively). A higher score is associated with a higher ability to cope stressfull events and higher stress resilience.

  7. EEG Alpha band power [ Time Frame: Change from Baseline Measure at the 1st day at 7 days ]
  8. EEG Alpha band functional connectivity [ Time Frame: Change from Baseline Measure at the 1st day at 7 days ]
  9. EEG Beta band power [ Time Frame: Change from Baseline Measure at the 1st day at 7 days ]
  10. EEG Beta band functional connectivity [ Time Frame: Change from Baseline Measure at the 1st day at 7 days ]
  11. EEG: Frontal alpha band asymmetry (right side activity) [ Time Frame: Change from Baseline Measure at the 1st day at 7 days ]
  12. EEG: Frontal theta/beta band ratio [ Time Frame: Change from Baseline Measure at the 1st day at 7 days ]
  13. EDA: number of individual phasic responses [ Time Frame: Change from Baseline Measure at the 1st day at 7 days ]
  14. EDA: number of summed amplitude of phasic responses [ Time Frame: Change from Baseline Measure at the 1st day at 7 days ]
  15. ECG: Low frequency response in the heart rate variability [ Time Frame: Change from Baseline Measure at the 1st day at 7 days ]
  16. ECG: High frequency response in the heart rate variability [ Time Frame: Change from Baseline Measure at the 1st day at 7 days ]
  17. ECG: Average heart rate [ Time Frame: Change from Baseline Measure at the 1st day at 7 days ]
  18. ECG: Standard deviation of normal to normal intervals (SDNN) [ Time Frame: Change from Baseline Measure at the 1st day at 7 days ]
  19. Satisfaction with Life Scale [ Time Frame: Change from Baseline Measure at the 1st day at 7 days ]
    The five-item scale is used to measure life satisfaction. This is understood as a multifactorial construct with affective and cognitive-evaluative components. The affective components are characterized by the presence of positive and the absence of negative emotions. The cognitive-evaluative components are composed of global and domain-specific satisfaction in different areas of life. The response format is a 7-point Likert-rating scale (1 = "not at all" and 7 = "completely").


Secondary Outcome Measures :
  1. Complementary and Alternative Medicine (CAM) Health Belief Questionnaire [ Time Frame: Change from Baseline Measure at the 1st day at 7 days ]
    The questionnaire collects the attitude and openness towards complementary and alternative medicine. It uses 10 items with a 7-point Likert-rating scale (1 = "not at all" and 7 = "completely"). Higher values are related to stronger beliefs in complementary and alternative medicines (CAM).

  2. Adapted Paranormal Experience Scale [ Time Frame: Change from Baseline Measure at the 1st day at 7 days ]
    The adapted scale for paranormal experiences asks in 12 items experiences of supernatural phenomena with a binary answer format. Higher values are related to stronger beliefs in and susceptibility for paranormal experiences.

  3. Revised Paranormal Belief Scale [ Time Frame: Change from Baseline Measure at the 1st day at 7 days ]
    With 26 items, the scale of paranormal beliefs in the seven dimensions of Traditional Religious Belief, Psi, Witchcraft, Superstition, Spiritualism, Extraordinary Life Forms and Precognition asks. A 7-point Likert rating scale is used as the answer format (1 = "not at all" and 7 = " completely"). Higher values are related to stronger susceptibility for paranormal beliefs.

  4. Vienna matrix test [ Time Frame: 1st day [Pre-session] ]
    The WMT-2 is a shortened version of the Vienna Matrices Test with rapidly scaled 18 items. Depending on the type of item, the test measures the ability to reason when dealing with abstract symbols. According to Cattell, this can be classified as fluid intelligence (ability to think logically, recognize connections and figural relationships and find solutions to problems), which is largely independent of learning experience and culture. The concept of the WMT is based on that of Raven's Progressive Matrices. Higher values indicate higher ability in fluid intelligence.

  5. Short version of the Big 5 Inventory [ Time Frame: 1st day [Pre-session] ]
    The short version of the Big 5 inventory includes the personality dimensions openness to experience, conscientiousness, extraversion, tolerance and neuroticism. The inventory uses 21 items with a 7-point likert scale (1 -strongly disagress to 7 strongly agree) and is considered economic with an average processing time of less than 2 minutes. The results show satisfactory psychometric parameters for the BFI-K. In addition to sufficient reliability, the factorial validity of the procedure as well as high agreement with acquaintance judgements and with other established procedures for recording the five-factor model could be confirmed.

  6. Karolinska Sleepiness Scale [ Time Frame: Change from Baseline Measure at the 1st day at 7 days ]
    The Karolinska Sleepiness Scale asks for the currently felt fatigue in an item on a scale from 0 to 9. The scale can also be displayed via a visual analogue scale. High values are correlates with high sleepiness.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy males and females (approximately 50:50)
  • sufficient language skills
  • No knowledge or experience with the Qi-Shield device

Exclusion Criteria:

  • neurological diseases such as e.g. epilepsy or psychiatric disorders (asked for by selfdisclosure) or the intake of centrally effective drugs, as these factors can influence electrophysiological signals such as EEG ECG and EDA.
  • persons with COVID risk factors

Since it has been repeatedly reported that EHS individuals are prone to certain physiological reactions that are outside the normal range, we will exclude these individuals in the present study


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04571775


Contacts
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Contact: Katharina Lingelbach, Master +49 711 970 5342 katharina.lingelbach@iao.fraunhofer.de
Contact: Mathias Vukelić, PhD +49 711 970 5183 mathias.vukelic@iao.fraunhofer.de

Locations
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Germany
Fraunhofer Institute for Industrial Engineering IAO Recruiting
Stuttgart, Germany, 70569
Contact: Katharina Lingelbach, Master    +49 711 970 5342    katharina.lingelbach@iao.fraunhofer.de   
Contact: Mathias Vukelić, PhD    +49 711 970 5183    mathias.vukelic@iao.fraunhofer.de   
Sponsors and Collaborators
Waveguard GmbH
University of Stuttgart, Institute of Human Factors and Technology Management
Investigators
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Principal Investigator: Katharina Lingelbach Fraunhofer Institute for Industrial Engineering IAO
  Study Documents (Full-Text)

Documents provided by Waveguard GmbH:
Informed Consent Form  [PDF] September 20, 2020

Publications:
Aubeck, H.-J. (1989). Querschnitt der Parapsychologie. Eine Einführung in die okkulte Wissenschaft. Deutschland, Frankfurt a. M.: R. G. Fischer.
Blankertz, B., Sanelli, C., Halder, S., Hammer, E., Kübler, A., Müller, K. R., ... & Dickhaus, T. (2009). Predicting BCI performance to study BCI illiteracy. BMC Neuroscience, 10(Suppl 1), 84. doi: 10.1016/j.neuroimage.2010.03.022
Bortz, J., & Döring, N. (2006). Forschungsmethoden und Evaluation: für Human- und Sozialwissenschaftler. Heidelberg, de: Springer-Medizin-Verl.
Breyer, B., & Bluemke, M. (2016). Deutsche Version der Positive and Negative Affect Schedule PANAS (GESIS Panel). Zusammenstellung sozialwissenschaftlicher Items und Skalen (ZIS). https://doi.org/10.6102/zis242
Eid, M., Gollwitzer, M., & Schmitt, M. (2017). Statistik und Forschungsmethoden: mit Online-Materialien. Weinheim, Basel, de: Beltz Verlag.
Formann, A. K., & Piswanger, K. (1979). WMT-2. Wiener Matrizen-Test. Ein Rasch-skalierter sprachfreier Intelligenztest. Göttingen: Hofgrefe Testzentrale.
Hergovich, A. (2003). Field dependence, suggestibility and belief in paranormal phenomena. Personality and Individual Differences, 34, 195-209. https://doi.org/10.1016/S0191-8869(02)00022-3
Hergovich, A., & Arendasy, M. (2005). Critical thinking ability and belief in the paranormal. Personality and Individual Differences, 38, 1805-1812. https://doi.org/10.1016/j.paid.2004.11.008
Janke, S., & Glöckner-Rist, A. (2012). Deutsche Version der Satisfaction with Life Scale (SWLS). Zusammenstellung sozialwissenschaftlicher Items und Skalen (ZIS). https://doi.org/10.6102/zis147
Laux, L., Glanzmann, P., Schaffner, P., & Spielberger, C. D. (1981). Das State-Trait-Angstinventar (STAI). Weinheim, DE: Beltz.
Psychiatric Research Unit, WHO Collaborating Center for Mental Health, WHO-5 Frederiksborg General Hospital, DK-3400 Hillerød. Abgerufen am 01.07.2020 unter https://www.thieme.de/de/thieme-telecare/143343.htm
Rammstedt, B., & John, O. P. (2005). Kurzversion des big five inventory (BFI-K). Diagnostica, 51, 195-206.
Tobacyk, J. (2004). A Revised Paranomal Belief Scale. International Journal of Transpersonal Studies, 23, 94 - 98. doi:10.1037/t14015-000
Watson G., & Glaser E.M., (1991). Watson-Glaser Critical Thinking Appraisal Manual. London: Psychological Corporation
WHO (2004, October 25 -27). WHO workshop on electromagnetic hypersensitivity. Prague, Czech Republic. Abgerufen am 01.07.2020 unter https://www.who.int/peh-emf/meetings/hypersensitivity_prague2004/en/
Zhang, J., Hua, Y., Xiu, L., Oei, T. P., & Hu, P. (2020). Resting state frontal alpha asymmetry predicts emotion regulation difficulties in impulse control. Personality and Individual Differences, 159, 109870. https://doi.org/10.1016/j.paid.2020.109870

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Responsible Party: Waveguard GmbH
ClinicalTrials.gov Identifier: NCT04571775    
Other Study ID Numbers: WAVEGUARD STRESS HUMANS FR01
First Posted: October 1, 2020    Key Record Dates
Last Update Posted: October 9, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Waveguard GmbH:
EEG
ECG
EDA
resting state
well-being
stress
sleep