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Completed

NCT Number: NCT04780724

Evaluation of SpO2 Measurement Using a Smartwatch

The aim of the study is to compare the measurement of peripheral blood oxygen saturation using a smartwatch with a medical-grade pulse oximeter.

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Key information

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Biomedical Engineering, Czech Technical University in Prague

Kladno, 27201, Czechia

About this study

Recently, wearables, like smartwatches, have been gaining new possibilities in monitoring biological signals and they are used for home monitoring of health conditions. The newest models of smartwatches even measure peripheral blood oxygen saturation (SpO2). The study aims to compare the measurement of peripheral blood oxygen saturation using the latest smartwatch with a medical-grade pulse oximeter under the condition of normobaric hypoxia. Healthy participants will breathe oxygen-reduced mixtures (the hypoxic gas mixture of 12% O2 and 88% N2 and the hypercapnic and hypoxic gas mixture of 12% O2, 5% CO2, and 83% N2), which will temporarily reduce their blood oxygen saturation. SpO2 measurements will be taken by hand from the watch and the pulse oximeter simultaneously. The agreement of the measurements of both devices will be evaluated.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • healthy volunteers from the Czech Technical University

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

Hypoxic gas mixture

Other

Gas mixture of 12% O2 and 88% N2 for five minutes.

Hypercapnic and hypoxic gas mixture

Other

Gas mixture of 12% O2, 5% CO2, and 88% N2 for five minutes.

SpO2 measurement

Other

Two SpO2 measuring devices are active simultaneously during measurement.

Primary outcomes

  1. Similarity of SpO2 readings

    Time frame: 2 hours

    The agreement of SpO2 measurements of both monitoring devices will be evaluated.

Sponsors and collaborators

Lead sponsor

Czech Technical University in Prague

Other

Registry information

Acronym: ESMUS

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 3, 2021
Registry last updated
Jan 28, 2022

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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