Blood PressureNCT05302193
Non-invasive Blood Pressure Measurement Using Samsung Smartwatch
A study testing Calm measurement of blood pressure and heart rate (before physical activity), Physical activity and Calm measurement of blood pressure and heart rate (after physical activity) in people with Blood Pressure and Heart Rate, run by Czech Technical University in Prague at 1 site in Czechia.
Trial summary
The aim of this study is to verify the accuracy of blood pressure and heart rate measurement by Samsung smartwatches compared to a standard monitor of vital signs used in intensive care units. Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure, Heart Rate
- What is being tested?
- Calm measurement of blood pressure and heart rate (before physical activity), Physical activity and Calm measurement of blood pressure and heart rate (after physical activity)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Mar 2021to 30 Sep 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 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- healthy volunteers
Who cannot join
- any acute illness
- pregnancy
- severe cardiovascular conditions
- severe asthma or other severe respiratory conditions
- 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 this study is to verify the accuracy of blood pressure and heart rate measurement by Samsung smartwatches compared to a standard monitor of vital signs used in intensive care units.
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. Heart rate measurement is a common function of smartwatches, some smartwatch models even measure blood pressure. The study aims to compare the measurement of blood pressure and heart rate using the latest smartwatch with a vital signs monitor used in clinical practice. Blood pressure and heart rate measurements will be taken by hand from the watch and the vital signs monitor simultaneously. The agreement of the measurements of both devices will be evaluated.
- Conditions
- Blood Pressure, Heart Rate
- Being tested
- Calm measurement of blood pressure and heart rate (before physical activity), Physical activity, Calm measurement of blood pressure and heart rate (after physical activity)
- Keywords
- blood pressure measurement, heart rate measurement, smartwatch
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calm measurement of blood pressure and heart rate (before physical activity)Other
Simultaneous blood pressure and heart rate measurements at minutes 2 and 5.5 of the experiment.
Physical activityOther
Five minutes of physical activity, between times 7.5 min and 12.5 min of the experimental part. Riding on a spinning ergometer with a standardized load of 1 W/kg.
Calm measurement of blood pressure and heart rate (after physical activity)Other
Simultaneous blood pressure and heart rate measurements at times 15.5, 17, 20.5 and 22 minutes of the experimental part.
| Study group | Role | What they receive |
|---|---|---|
| Blood pressure and heart rate measurement | Experimental | Calm measurement of blood pressure and heart rate simultaneously by smartwatch and vital signs monitor. Each participant will undergo this measurement a total of 6 times. Receives: Other: Calm measurement of blood pressure and heart rate (before physical activity); Other: Physical activity; Other: Calm measurement of blood pressure and heart rate (after physical activity) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Similarity of blood pressure measurements from two devices
The agreement of systolic and diastolic blood pressure measurements of both monitoring devices will be evaluated.
Measured: 1 hour
Similarity of heart rate measurements from two devices
The agreement of heart rate measurements of both monitoring devices will be evaluated.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start1 Mar 2021
- Primary completion30 Sep 2021
- Study completion30 Sep 2021
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 Blood PressureStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Two measuring devices are active simultaneously during measurement of blood pressure and heart rate on each participant and their functioning is compared.
- Masking
- None (open label)
- Enrolment
- 27 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, MSc, Principal investigator, Czech Technical University in PragueJakub Rafl, PhD, Principal investigator, Czech Technical University in PragueMartin Rozanek, PhD, Principal investigator, Czech Technical University in Prague
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05302193
- Sponsor's protocol ID
- NIBPsmartwatch21
- Status last verified
- Mar 2025
- First submitted
- 16 Mar 2022
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hahnen C, Freeman CG, Haldar N, Hamati JN, Bard DM, Murali V, Merli GJ, Joseph JI, van Helmond N. Accuracy of Vital Signs Measurements by a Smartwatch and a Portable Health Device: Validation Study. JMIR Mhealth Uhealth. 2020 Feb 12;8(2):e16811. doi: 10.2196/16811.
PubMed 32049066
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Blood Pressure Measurement Using Samsung Smartwatch
- ClinicalTrials.gov ID
- NCT05302193
- Acronym / sponsor ID
- NIBPsmartwatch21
- Conditions
- Blood Pressure, Heart Rate
- Keywords
- blood pressure measurement, heart rate measurement, smartwatch
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Czech Technical University in PragueUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 31 Mar 2022 (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 this study is to verify the accuracy of blood pressure and heart rate measurement by Samsung smartwatches compared to a standard monitor of vital signs used in intensive care units.
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. Heart rate measurement is a common function of smartwatches, some smartwatch models even measure blood pressure. The study aims to compare the measurement of blood pressure and heart rate using the latest smartwatch with a vital signs monitor used in clinical practice. Blood pressure and heart rate measurements will be taken by hand from the watch and the vital signs monitor simultaneously. The agreement of the measurements of both devices will be evaluated.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Two measuring devices are active simultaneously during measurement of blood pressure and heart rate on each participant and their functioning is compared.
| Arm | Type | Receives |
|---|---|---|
| Blood pressure and heart rate measurement | Experimental | Other: Calm measurement of blood pressure and heart rate (before physical activity), Other: Physical activity, Other: Calm measurement of blood pressure and heart rate (after physical activity)Calm measurement of blood pressure and heart rate simultaneously by smartwatch and vital signs monitor. Each participant will undergo this measurement a total of 6 times. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- healthy volunteers
Key exclusion criteria (6 listed)
- any acute illness
- pregnancy
- severe cardiovascular conditions
- severe asthma or other severe respiratory conditions
- 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 |
|---|---|---|
| Calm measurement of blood pressure and heart rate (before physical activity)Simultaneous blood pressure and heart rate measurements at minutes 2 and 5.5 of the experiment. | Other | Blood pressure and heart rate measurement |
| Physical activityFive minutes of physical activity, between times 7.5 min and 12.5 min of the experimental part. Riding on a spinning ergometer with a standardized load of 1 W/kg. | Other | Blood pressure and heart rate measurement |
| Calm measurement of blood pressure and heart rate (after physical activity)Simultaneous blood pressure and heart rate measurements at times 15.5, 17, 20.5 and 22 minutes of the experimental part. | Other | Blood pressure and heart rate measurement |
Primary outcome
Similarity of blood pressure measurements from two devices
Time frame: 1 hour
The agreement of systolic and diastolic blood pressure measurements of both monitoring devices will be evaluated.
Similarity of heart rate measurements from two devices
Time frame: 1 hour
The agreement of heart rate 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 25 Mar 2025.
- Background: PubMed 32049066Hahnen C, Freeman CG, Haldar N, Hamati JN, Bard DM, Murali V, Merli GJ, Joseph JI, van Helmond N. Accuracy of Vital Signs Measurements by a Smartwatch and a Portable Health Device: Validation Study. JMIR Mhealth Uhealth. 2020 Feb 12;8(2):e16811. doi: 10.2196/16811.
- 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, MSc principal investigator
Czech Technical University in Prague
Jakub Rafl, PhD principal investigator
Czech Technical University in Prague
Martin Rozanek, 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 Calm measurement of blood pressure and heart rate (before physical activity), Physical activity and Calm measurement of blood pressure and heart rate (after physical activity) in people with Blood Pressure and Heart Rate, 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 25 Mar 2025. 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 blood pressure measurements from two devices (time frame: 1 hour). The study lists 2 primary outcomes in all. 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 NCT05302193, 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 25 Mar 2025.