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

NCT04571775 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2020-10-09

No results posted yet for this study

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

Interventions

DEVICE

Qi-Shield user group

real device Qi-Shield (treatment)

DEVICE

Sham Qi-Shield user group

sham device (placebo)

Sponsors & Collaborators

  • University of Stuttgart, Institute of Human Factors and Technology Management

    collaborator UNKNOWN

  • Waveguard GmbH

    lead INDUSTRY

Principal Investigators

  • Katharina Lingelbach · Fraunhofer Institute for Industrial Engineering IAO

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-10-03
Primary Completion
2021-02-01
Completion
2021-02-01

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04571775 on ClinicalTrials.gov