HypoxiaCSMADTSNCT05789563
Comparison of SpO2 Measurement Accuracy of Different Types of Smartwatches
A study testing Hypoxia and Smartwatch model in people with Hypoxia, run by Czech Technical University in Prague at 1 site in Czechia.
Trial summary
The aim of the study is to compare the accuracy of peripheral blood oxygen saturation measurements using smartwatches from three manufacturers compared to a standard medical 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
- What is being tested?
- Hypoxia and Smartwatch model
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteCzechia
- Study dates
- 17 Mar 2023to 28 Jun 2023
- 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
- Passing the initial examination, which will determine the following data: wrist circumference, heart rate, blood pressure and blood oxygen saturation
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.
About this study
The aim of the study is to compare the accuracy of peripheral blood oxygen saturation measurements using smartwatches from three manufacturers compared to a standard medical pulse oximeter.
Read the detailed description
The aim is to create a study that compares multiple smartwatch models simultaneously with a standard medical pulse oximeter using a single measurement methodology. According to the available literature, no such study exists. The methodology of the study and the subsequent statistical evaluation are based on the guidelines of the standard ČSN EN ISO 80601-2-61, which specifies requirements for the basic safety and necessary functionality of pulse oximetry devices. The comparison will be performed non-invasively in healthy volunteers during gradual desaturation in the range of 70-100 % SpO2 (normobaric hypoxia). The data obtained could help to increase the awareness of the possibilities of SpO2 monitoring using smartwatches in medical conditions that are manifested by a decrease in SpO2 level over a longer time period, where measurement with a conventional oximeter is impractical.
- Conditions
- Hypoxia
- Being tested
- Hypoxia and Smartwatch model
- Keywords
- SpO2, Pulse oximetry, Smartwatch
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypoxia and Smartwatch modelOther
Breathing mixtures of O2 (14 %, 12 %, 10 %) balanced with N2 and monitoring SpO2 by one of the smartwatch models on left wrist and by pulse oximeter on left index finger.
| Study group | Role | What they receive |
|---|---|---|
| First smartwatch model | Experimental | Volunteers sequentially inhale three hypoxic gas mixtures each for 2.5 minute. Every measurement will begin with a two-minute stabilization phase, during which the physiological values of the volunteer will be checked. During the experiment, SpO2 measurements will be taken by hand from the watch and the pulse oximeter simultaneously. Receives: Other: Hypoxia and Smartwatch model |
| Second smartwatch model | Experimental | Volunteers sequentially inhale three hypoxic gas mixtures each for 2.5 minute. Every measurement will begin with a two-minute stabilization phase, during which the physiological values of the volunteer will be checked. During the experiment, SpO2 measurements will be taken by hand from the watch and the pulse oximeter simultaneously. Receives: Other: Hypoxia and Smartwatch model |
| Third smartwatch model | Experimental | Volunteers sequentially inhale three hypoxic gas mixtures each for 2.5 minute. Every measurement will begin with a two-minute stabilization phase, during which the physiological values of the volunteer will be checked. During the experiment, SpO2 measurements will be taken by hand from the watch and the pulse oximeter simultaneously. Receives: Other: Hypoxia and Smartwatch model |
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 every model of smartwatches and reference pulse oximeter will be evaluated
Measured: Under 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2023
- Study start17 Mar 2023
- Primary completion30 Apr 2023
- Study completion28 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 each measurement on each participant and their functioning is compared.
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Czech Technical University in Prague
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jakub Rafl, PhD., Principal investigator, Czech Technical University in Prague
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05789563
- Sponsor's protocol ID
- NVT_01_2023
- Acronym
- CSMADTS
- Status last verified
- Mar 2026
- First submitted
- 16 Mar 2023
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rafl 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 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of SpO2 Measurement Accuracy of Different Types of Smartwatches
- ClinicalTrials.gov ID
- NCT05789563
- Acronym / sponsor ID
- CSMADTS / NVT_01_2023
- Conditions
- Hypoxia
- Keywords
- SpO2, Pulse oximetry, Smartwatch
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Czech Technical University in PragueUniversity, hospital or other
- Study start
- 17 Mar 2023 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 28 Jun 2023 (actual)
- First posted
- 29 Mar 2023 (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 accuracy of peripheral blood oxygen saturation measurements using smartwatches from three manufacturers compared to a standard medical pulse oximeter.
Detailed description
The aim is to create a study that compares multiple smartwatch models simultaneously with a standard medical pulse oximeter using a single measurement methodology. According to the available literature, no such study exists. The methodology of the study and the subsequent statistical evaluation are based on the guidelines of the standard ČSN EN ISO 80601-2-61, which specifies requirements for the basic safety and necessary functionality of pulse oximetry devices. The comparison will be performed non-invasively in healthy volunteers during gradual desaturation in the range of 70-100 % SpO2 (normobaric hypoxia). The data obtained could help to increase the awareness of the possibilities of SpO2 monitoring using smartwatches in medical conditions that are manifested by a decrease in SpO2 level over a longer time period, where measurement with a conventional oximeter is impractical.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- All participants go through all study arms, in random order. Two measuring devices are active simultaneously during each measurement on each participant and their functioning is compared.
| Arm | Type | Receives |
|---|---|---|
| First smartwatch model | Experimental | Other: Hypoxia and Smartwatch modelVolunteers sequentially inhale three hypoxic gas mixtures each for 2.5 minute. Every measurement will begin with a two-minute stabilization phase, during which the physiological values of the volunteer will be checked. During the experiment, SpO2 measurements will be taken by hand from the watch and the pulse oximeter simultaneously. |
| Second smartwatch model | Experimental | Other: Hypoxia and Smartwatch modelVolunteers sequentially inhale three hypoxic gas mixtures each for 2.5 minute. Every measurement will begin with a two-minute stabilization phase, during which the physiological values of the volunteer will be checked. During the experiment, SpO2 measurements will be taken by hand from the watch and the pulse oximeter simultaneously. |
| Third smartwatch model | Experimental | Other: Hypoxia and Smartwatch modelVolunteers sequentially inhale three hypoxic gas mixtures each for 2.5 minute. Every measurement will begin with a two-minute stabilization phase, during which the physiological values of the volunteer will be checked. During the experiment, SpO2 measurements will be taken by hand from the watch and the pulse oximeter simultaneously. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Passing the initial examination, which will determine the following data: wrist circumference, heart rate, blood pressure and blood oxygen saturation
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 |
|---|---|---|
| Hypoxia and Smartwatch modelBreathing mixtures of O2 (14 %, 12 %, 10 %) balanced with N2 and monitoring SpO2 by one of the smartwatch models on left wrist and by pulse oximeter on left index finger. | Other | First smartwatch model, Second smartwatch model, Third smartwatch model |
Primary outcome
Similarity of SpO2 readings
Time frame: Under 1 hour
The agreement of SpO2 measurements of every model of smartwatches and reference pulse oximeter 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 11 Mar 2026.
- Background: 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.
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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.
Jakub Rafl, PhD. 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 Hypoxia and Smartwatch model in people with Hypoxia, 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 11 Mar 2026. 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: Under 1 hour). 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 NCT05789563, which also lists 1 linked publication.
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 11 Mar 2026.