HypoxiaESMUSNCT04780724
Evaluation of SpO2 Measurement Using a Smartwatch
A study testing Hypoxic gas mixture, Hypercapnic and hypoxic gas mixture and SpO2 measurement in people with Hypoxia and Hypercapnia, run by Czech Technical University in Prague at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypoxia, Hypercapnia
- What is being tested?
- Hypoxic gas mixture, Hypercapnic and hypoxic gas mixture and SpO2 measurement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteCzechia
- Study dates
- 15 Feb 2021to 30 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy volunteers from the Czech Technical University
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Czechia1 site
Faculty of Biomedical Engineering, Czech Technical University in Prague
Kladno, 27201
About this study
The aim of the study is to compare the measurement of peripheral blood oxygen saturation using a smartwatch with a medical-grade pulse oximeter.
Read the 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.
- Conditions
- Hypoxia, Hypercapnia
- Being tested
- Hypoxic gas mixture, Hypercapnic and hypoxic gas mixture, SpO2 measurement
- Keywords
- SpO2, pulse oximetry, smartwatch
- Medical subject headings
- Hypoxia, Hypercapnia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypoxic gas mixtureOther
Gas mixture of 12% O2 and 88% N2 for five minutes.
Hypercapnic and hypoxic gas mixtureOther
Gas mixture of 12% O2, 5% CO2, and 88% N2 for five minutes.
SpO2 measurementOther
Two SpO2 measuring devices are active simultaneously during measurement.
| Study group | Role | What they receive |
|---|---|---|
| Hypoxic | Experimental | Participants inhale ambient air, the hypoxic gas mixture, and ambient air. Receives: Other: Hypoxic gas mixture; Other: SpO2 measurement |
| Hypercapnic | Experimental | Participants inhale ambient air, the hypercapnic and hypoxic gas mixture, and the ambient air. Receives: Other: Hypercapnic and hypoxic gas mixture; Other: SpO2 measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Similarity of SpO2 readings
The agreement of SpO2 measurements of both monitoring devices will be evaluated.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2021
- Study start15 Feb 2021
- Primary completion30 Mar 2021
- Study completion30 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HypoxiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- 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 blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Czech Technical University in Prague
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Veronika Rafl Huttova, Principal investigator, Czech Technical University in Prague
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04780724
- Sponsor's protocol ID
- smartwatch21
- Acronym
- ESMUS
- Status last verified
- Jan 2022
- First submitted
- 1 Mar 2021
- Last updated
- 28 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rafl J, Kulhanek F, Kudrna P, Ort V, Roubik K. Response time of indirectly accessed gas exchange depends on measurement method. Biomed Tech (Berl). 2018 Nov 27;63(6):647-655. doi: 10.1515/bmt-2017-0070.
PubMed 28802098Lauterbach CJ, Romano PA, Greisler LA, Brindle RA, Ford KR, Kuennen MR. Accuracy and Reliability of Commercial Wrist-Worn Pulse Oximeter During Normobaric Hypoxia Exposure Under Resting Conditions. Res Q Exerc Sport. 2021 Sep;92(3):549-558. doi: 10.1080/02701367.2020.1759768. Epub 2020 Jul 7.
PubMed 32633688Rafl J, Bachman TE, Rafl-Huttova V, Walzel S, Rozanek M. Commercial smartwatch with pulse oximeter detects short-time hypoxemia as well as standard medical-grade device: Validation study. Digit Health. 2022 Oct 11;8:20552076221132127. doi: 10.1177/20552076221132127. eCollection 2022 Jan-Dec.
PubMed 36249475
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of SpO2 Measurement Using a Smartwatch
- ClinicalTrials.gov ID
- NCT04780724
- Acronym / sponsor ID
- ESMUS / smartwatch21
- Conditions
- Hypoxia, Hypercapnia
- Keywords
- SpO2, pulse oximetry, smartwatch
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Czech Technical University in PragueUniversity, hospital or other
- Study start
- 15 Feb 2021 (actual)
- Primary completion
- 30 Mar 2021 (actual)
- Study completion
- 30 Mar 2021 (actual)
- First posted
- 3 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Hypoxic | Experimental | Other: Hypoxic gas mixture, Other: SpO2 measurementParticipants inhale ambient air, the hypoxic gas mixture, and ambient air. |
| Hypercapnic | Experimental | Other: Hypercapnic and hypoxic gas mixture, Other: SpO2 measurementParticipants inhale ambient air, the hypercapnic and hypoxic gas mixture, and the ambient air. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy volunteers from the Czech Technical University
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypoxic gas mixtureGas mixture of 12% O2 and 88% N2 for five minutes. | Other | Hypoxic |
| Hypercapnic and hypoxic gas mixtureGas mixture of 12% O2, 5% CO2, and 88% N2 for five minutes. | Other | Hypercapnic |
| SpO2 measurementTwo SpO2 measuring devices are active simultaneously during measurement. | Other | Hypercapnic, Hypoxic |
Primary outcome
Similarity of SpO2 readings
Time frame: 2 hours
The agreement of SpO2 measurements of both monitoring devices will be evaluated.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2022.
- Background: PubMed 28802098Rafl J, Kulhanek F, Kudrna P, Ort V, Roubik K. Response time of indirectly accessed gas exchange depends on measurement method. Biomed Tech (Berl). 2018 Nov 27;63(6):647-655. doi: 10.1515/bmt-2017-0070.
- Background: PubMed 32633688Lauterbach CJ, Romano PA, Greisler LA, Brindle RA, Ford KR, Kuennen MR. Accuracy and Reliability of Commercial Wrist-Worn Pulse Oximeter During Normobaric Hypoxia Exposure Under Resting Conditions. Res Q Exerc Sport. 2021 Sep;92(3):549-558. doi: 10.1080/02701367.2020.1759768. Epub 2020 Jul 7.
- Derived from this study: PubMed 36249475Rafl J, Bachman TE, Rafl-Huttova V, Walzel S, Rozanek M. Commercial smartwatch with pulse oximeter detects short-time hypoxemia as well as standard medical-grade device: Validation study. Digit Health. 2022 Oct 11;8:20552076221132127. doi: 10.1177/20552076221132127. eCollection 2022 Jan-Dec.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Veronika Rafl Huttova principal investigator
Czech Technical University in Prague
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypoxic gas mixture, Hypercapnic and hypoxic gas mixture and SpO2 measurement in people with Hypoxia and Hypercapnia, run by Czech Technical University in Prague at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Similarity of SpO2 readings (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04780724, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2022.