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Evaluation of SpO2 Measurement Using a Smartwatch (ESMUS)

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ClinicalTrials.gov Identifier: NCT04780724
Recruitment Status : Active, not recruiting
First Posted : March 3, 2021
Last Update Posted : March 3, 2021
Sponsor:
Information provided by (Responsible Party):
Czech Technical University in Prague

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.

Condition or disease Intervention/treatment Phase
Hypoxia Hypercapnia Other: Hypoxic gas mixture Other: Hypercapnic and hypoxic gas mixture Other: SpO2 measurement Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
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.
Masking: Single (Participant)
Primary Purpose: Other
Official Title: Evaluation of SpO2 Measurement Using a Smartwatch
Actual Study Start Date : February 15, 2021
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Nitrox

Arm Intervention/treatment
Experimental: Hypoxic
Participants inhale ambient air, the hypoxic gas mixture, and ambient air.
Other: Hypoxic gas mixture
Gas mixture of 12% O2 and 88% N2 for five minutes.

Other: SpO2 measurement
Two SpO2 measuring devices are active simultaneously during measurement.

Experimental: Hypercapnic
Participants inhale ambient air, the hypercapnic and hypoxic gas mixture, and the ambient air.
Other: Hypercapnic and hypoxic gas mixture
Gas mixture of 12% O2, 5% CO2, and 88% N2 for five minutes.

Other: SpO2 measurement
Two SpO2 measuring devices are active simultaneously during measurement.




Primary Outcome Measures :
  1. Similarity of SpO2 readings [ Time Frame: 2 hours ]
    The agreement of SpO2 measurements of both monitoring devices will be evaluated.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04780724


Locations
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Czechia
Faculty of Biomedical Engineering, Czech Technical University in Prague
Kladno, Czechia, 27201
Sponsors and Collaborators
Czech Technical University in Prague
Investigators
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Principal Investigator: Veronika Rafl Huttova Czech Technical University in Prague
Publications:
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Responsible Party: Czech Technical University in Prague
ClinicalTrials.gov Identifier: NCT04780724    
Other Study ID Numbers: smartwatch21
First Posted: March 3, 2021    Key Record Dates
Last Update Posted: March 3, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Czech Technical University in Prague:
SpO2
pulse oximetry
smartwatch
Additional relevant MeSH terms:
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Hypoxia
Hypercapnia
Signs and Symptoms, Respiratory
Nitrox
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs