NCT05789563

Comparison of SpO2 Measurement Accuracy of Different Types of Smartwatches

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Czech Technical University in Prague · Academic / Other
• Sex: All
• Age: 18 Years – 30 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Hypoxia

Interventions

Type	Name	Description
OTHER	Hypoxia and Smartwatch model	Breathing mixtures of O2 (14 %, 12 %, 10 %) balanced with N2 and monitoring SpO2 by one of the smartwatch models on left wrist and by pulse oximeter on left index finger.

Timeline

• Start date: 2023-03-17
• Primary completion: 2023-04-30
• Completion: 2023-06-28
• First posted: 2023-03-29
• Last updated: 2026-03-11

Locations

1 site across 1 country: Czechia