BARABAZ Analyseert Biometrie

The aim of this study is the validation of a new measurement system, BARABAZ®. BARABAZ® is a non-invasive measurement system that will be used for functional analyses of the human body, aiming to screen for disease/overload. To be able to do this, the BARABAZ® uses two separate measurement systems: a bio-impedance system and a digital pulse oximeter. In addition, BARABAZ® is equipped with two sets of sensors, which will be placed on the forehead of the patient. This allows BARABAZ® to collect data on heartrate variability, galvanic skin response and oxygen saturation. Each of these outcomoe measures will be compared to a validated alternative.

In this validation study it will be investigated whether the digital pulse oximeter of BARABAZ®, which uses Blood Volume Pulse (BVP) sensors, can be used to measure HRV. The BVP sensors use photoplethysmography (PPG): measuring changes in blood volume using an optic method that measures the amount of infrared light absorbed by the blood.
ECG is currently the gold standard to determine HRV, this data will be collected using the TMSi Mobi 8. Measuring the HRV with both measurement systems and comparing the data on several parameters (R-R intervals; N-N intervals; and RMSSD), allows us to make an educated conclusion whether the digital pulse oximeter of BARABAZ® is a valid alternative for determining HRV in a population of healthy subjects.

Secondly, it will be investigated whether the oximeter of BARABAZ® is a valid alternative to determine oxygen saturation. This will be done by comparing SpO2-values of BARABAZ® to those measured by a Nonin Onyx Vantage 9590 professional clinical pulse oximeter.
Lastly, it will be investigated whether the GSR data of BARABAZ® are a valid alternative for the GSR data measured with the Shimmer 3 GSR+.

Data of 62 participants will be collected for this study. All measurements will be performed 3 times for each of the outcome measures, to ensure a valid dataset. All measurement systems have a CE-certificate and measure non-invasive. Participants will not benefit from partaking in this study directly. However, there will not be any downsides to partaking either. Risks are neglectable.

The study is initiated by BARABAZ, and will be executed by Kinetic Analysis.

A new health system is being validated on heart rate variability; galvanic skin response and oxygen saturation.

All measurements will be done once, therefore there will be only one timepoint.

This study is a validation study on HRV, GSR and oxygen saturation, therefore there is no actual intervention. All participants will be measured with all measurement systems to allow for a direct comparison on all parameters.

A standard measurement protocol will be instated to ensure measurements are done exactly the same way for every participant. This way of measurement is in line with the standard approach within the healthcare sector regarding measurement tools. In addition, the same setup will be used to minimise the influence of external factors, such as lighting.

In theory, the internal software of the measurement equipment should correct for external light sources, preventing external light sources from influencing the data. However, to ensure the influence of external light sources is equal in every trial, the measurements will be performed in the same space in the room every time.



All parameters will be measured 3 times for every participant to ensure a valid dataset. If the first trial appears to have a complete dataset, this trial will be used for analyses. However, if the dataset is incomplete or contains a measurement error, the second dataset will be used. In case the second set is incomplete or contains errors, data from the third trial will be used.