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Completed

NCT Number: NCT05789563

Comparison of SpO2 Measurement Accuracy of Different Types of Smartwatches

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.

Completed

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Key information

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Czech Technical University in Prague

Kladno, 27201, Czechia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Passing the initial examination, which will determine the following data: wrist circumference, heart rate, blood pressure and blood oxygen saturation

Exclusion criteria

  • pregnancy
  • severe cardiovascular conditions
  • severe asthma or other severe respiratory conditions
  • injury to the upper limbs or hands that could affect the peripheral perfusion
  • diabetes
  • hypotension or hypertension

Treatment and study plan

Hypoxia and Smartwatch model

Other

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.

Primary outcomes

  1. Similarity of SpO2 readings

    Time frame: Under 1 hour

    The agreement of SpO2 measurements of every model of smartwatches and reference pulse oximeter will be evaluated

Sponsors and collaborators

Lead sponsor

Czech Technical University in Prague

Other

Registry information

Acronym: CSMADTS

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 29, 2023
Registry last updated
Mar 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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