Evaluation of SpO2 Measurement Using a Smartwatch

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04780724

Acronym

ESMUS

Enrollment

Registered

2021-03-03

Start date

2021-02-15

Completion date

2021-03-30

Last updated

2022-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypercapnia, Hypoxia

Keywords

SpO2, pulse oximetry, smartwatch

Brief summary

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

Detailed description

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.

Interventions

OTHERHypoxic gas mixture

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

OTHERHypercapnic and hypoxic gas mixture

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

OTHERSpO2 measurement

Two SpO2 measuring devices are active simultaneously during measurement.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

OTHER

Masking

SINGLE (Subject)

Intervention model description

All participants go through all study arms, in random order. Two measuring devices are active simultaneously during measurement on each participant and their functioning is compared.

Eligibility

Sex/Gender

ALL

Age

18 Years to 30 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Similarity of SpO2 readings	2 hours	The agreement of SpO2 measurements of both monitoring devices will be evaluated.

Countries

Czechia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026