Evaluation of SpO2 Measurement Using a Smartwatch

Study Overview
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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.

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.

Official Title
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Evaluation of SpO2 Measurement Using a Smartwatch

Conditions
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Hypoxia, Hypercapnia

Intervention / Treatment
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* Other: Hypoxic gas mixture
* Other: Hypercapnic and hypoxic gas mixture
* Other: SpO2 measurement


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hypoxic<br>Participants inhale ambient air, the hypoxic gas mixture, and ambient air. | Other: Hypoxic gas mixture<br>* Gas mixture of 12% O2 and 88% N2 for five minutes.<br>Other: SpO2 measurement<br>* Two SpO2 measuring devices are active simultaneously during measurement.<br>|
| Experimental: Hypercapnic<br>Participants inhale ambient air, the hypercapnic and hypoxic gas mixture, and the ambient air. | Other: Hypercapnic and hypoxic gas mixture<br>* Gas mixture of 12% O2, 5% CO2, and 88% N2 for five minutes.<br>Other: SpO2 measurement<br>* Two SpO2 measuring devices are active simultaneously during measurement.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Similarity of SpO2 readings | The agreement of SpO2 measurements of both monitoring devices will be evaluated. | 2 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SpO2, pulse oximetry, smartwatch