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The aim of the study is to compare the accuracy of peripheral blood oxygen saturation measurements using smartwatches from three manufacturers compared to a standard medical pulse oximeter.
The aim is to create a study that compares multiple smartwatch models simultaneously with a standard medical pulse oximeter using a single measurement methodology. According to the available literature, no such study exists. The methodology of the study and the subsequent statistical evaluation are based on the guidelines of the standard ČSN EN ISO 80601-2-61, which specifies requirements for the basic safety and necessary functionality of pulse oximetry devices. The comparison will be performed non-invasively in healthy volunteers during gradual desaturation in the range of 70-100 % SpO2 (normobaric hypoxia). The data obtained could help to increase the awareness of the possibilities of SpO2 monitoring using smartwatches in medical conditions that are manifested by a decrease in SpO2 level over a longer time period, where measurement with a conventional oximeter is impractical.
Age
18 - 30 years
Sex
ALL
Healthy Volunteers
Yes
Czech Technical University in Prague
Kladno, Czechia
Start Date
March 17, 2023
Primary Completion Date
April 30, 2023
Completion Date
June 28, 2023
Last Updated
March 11, 2026
18
ACTUAL participants
Hypoxia and Smartwatch model
OTHER
Lead Sponsor
Czech Technical University in Prague
NCT07326293
NCT06966934
Data Source & Attribution
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