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

NCT04571775 | Unknown

• 1 other identifier: WAVEGUARD STRESS HUMANS FR01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Lifestyle

Keywords

EEG; ECG; EDA; resting state; well-being; stress; sleep

Outcome Measures

Primary Outcomes (19)

• Adapted Pittsburgh Sleep Quality Index (PSQI)

  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.

  Change from Baseline Measure at the 1st day at 7 days

• WHO-5

  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.

  Change from Baseline Measure at the 1st day at 7 days

• State Trait Anxiety Inventory

  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.

  Change from Baseline Measure at the 1st day at 7 days

• Positive and Negative Affect Schedule , PANAS

  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").

  Change from Baseline Measure at the 1st day at 7 days

• Adapted Perceived Stress Scale

  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.

  Change from Baseline Measure at the 1st day at 7 days

• Brief Resilience Scale

  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.

  Change from Baseline Measure at the 1st day at 7 days

• EEG Alpha band power

  Change from Baseline Measure at the 1st day at 7 days

• EEG Alpha band functional connectivity

  Change from Baseline Measure at the 1st day at 7 days

• EEG Beta band power

  Change from Baseline Measure at the 1st day at 7 days

• EEG Beta band functional connectivity

  Change from Baseline Measure at the 1st day at 7 days

• EEG: Frontal alpha band asymmetry (right side activity)

  Change from Baseline Measure at the 1st day at 7 days

• EEG: Frontal theta/beta band ratio

  Change from Baseline Measure at the 1st day at 7 days

• EDA: number of individual phasic responses

  Change from Baseline Measure at the 1st day at 7 days

• EDA: number of summed amplitude of phasic responses

  Change from Baseline Measure at the 1st day at 7 days

• ECG: Low frequency response in the heart rate variability

  Change from Baseline Measure at the 1st day at 7 days

• ECG: High frequency response in the heart rate variability

  Change from Baseline Measure at the 1st day at 7 days

• ECG: Average heart rate

  Change from Baseline Measure at the 1st day at 7 days

• ECG: Standard deviation of normal to normal intervals (SDNN)

  Change from Baseline Measure at the 1st day at 7 days

• Satisfaction with Life Scale

  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").

  Change from Baseline Measure at the 1st day at 7 days

Secondary Outcomes (6)

• Complementary and Alternative Medicine (CAM) Health Belief Questionnaire

  Change from Baseline Measure at the 1st day at 7 days

• Adapted Paranormal Experience Scale

  Change from Baseline Measure at the 1st day at 7 days

• Revised Paranormal Belief Scale

  Change from Baseline Measure at the 1st day at 7 days

• Vienna matrix test

  1st day [Pre-session]

• Short version of the Big 5 Inventory

  1st day [Pre-session]

Study Arms (3)

Qi-Shield user group

ACTIVE COMPARATOR

Device: Qi-Shield user group

Sham Qi-Shield user group

SHAM COMPARATOR

Device: Sham Qi-Shield user group

No Qi-Shield device group

NO INTERVENTION

Interventions

Qi-Shield user group DEVICE

real device Qi-Shield (treatment)

Qi-Shield user group

Sham Qi-Shield user group DEVICE

sham device (placebo)

Sham Qi-Shield user group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Waveguard GmbH: lead
• University of Stuttgart, Institute of Human Factors and Technology Management: collaborator

Study Sites (1)

Fraunhofer Institute for Industrial Engineering IAO

Stuttgart, 70569, Germany

RECRUITING

Related Publications (41)

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Study Officials

• Katharina Lingelbach

  Fraunhofer Institute for Industrial Engineering IAO

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katharina Lingelbach, Master

CONTACT

+49 711 970 5342; katharina.lingelbach@iao.fraunhofer.de

Mathias Vukelić, PhD

CONTACT

+49 711 970 5183; mathias.vukelic@iao.fraunhofer.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2020
• First Posted: October 1, 2020
• Study Start: October 3, 2020
• Primary Completion: February 1, 2021
• Study Completion: February 1, 2021
• Last Updated: October 9, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)