Evaluation of SpO2 Measurement Using a Smartwatch

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-15

Study Completion Date

2021-03-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Hypoxia Hypercapnia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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Hypoxic

Participants inhale ambient air, the hypoxic gas mixture, and ambient air.

Group Type EXPERIMENTAL

Hypoxic gas mixture

Intervention Type OTHER

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

SpO2 measurement

Intervention Type OTHER

Two SpO2 measuring devices are active simultaneously during measurement.

Hypercapnic

Participants inhale ambient air, the hypercapnic and hypoxic gas mixture, and the ambient air.

Group Type EXPERIMENTAL

Hypercapnic and hypoxic gas mixture

Intervention Type OTHER

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

SpO2 measurement

Intervention Type OTHER

Two SpO2 measuring devices are active simultaneously during measurement.

Interventions

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Hypoxic gas mixture

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

Intervention Type OTHER

Hypercapnic and hypoxic gas mixture

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

Intervention Type OTHER

SpO2 measurement

Two SpO2 measuring devices are active simultaneously during measurement.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes