HypertensionBPLONGNCT06098092
Long-term Accuracy and Stability of Blood Pressure Measurements From a Smartwatch: Prospective Validation Study
A study testing Long-term non-invasive Blood pressure monitoring in people with Hypertension and Blood Pressure, run by Czech Technical University in Prague at 2 sites in Czechia.
Trial summary
The aim of the study is to perform an experimental validation of the long-term accuracy of blood pressure measurement using the Samsung Galaxy Smartwatch Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Blood Pressure
- What is being tested?
- Long-term non-invasive Blood pressure monitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 2 sitesCzechia
- Study dates
- 13 Oct 2023to 1 Nov 2025
- 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 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteer
Who cannot join
- post-traumatic conditions of the upper limbs
- tattoos, birthmarks, injuries or diseases of the skin on the wrists of hands
- cardiac arrhythmias
- circulatory or peripheral varcular disease
- aortic valve disease
- myocardiopathy
Show all 13Show fewer
- other cardiovascular diseases
- pregnancy
- kidney disease
- diabetes
- neurotic disorder
- haemostatic disorders
- use of blood-thinning drugs
Trial locations and contacts
2 sites in 1 country.
Czechia2 sites
Czech Technical University in Prague
Kladno, 27201
Faculty of biomedical Engineering, Czech Technical University in Prague
Kladno, 27201
About this study
Official title: Experimental Validation of the Long-term Accuracy of Blood Pressure Measurement Using a Smartwatch
The aim of the study is to perform an experimental validation of the long-term accuracy of blood pressure measurement using the Samsung Galaxy Smartwatch
Read the detailed description
Blood pressure is one of the basic vital signs monitored and is one of the most important indicators of a patient's health status. Cardiovascular disease is one of the leading causes of death worldwide. One of the major risk factors for cardiovascular disease is hypertension, which is globally attributed to one third of deaths in the world population. To improve the prevention of hypertension, self-monitoring of blood pressure is increasingly recommended. This project involves an experimental validation of the long-term accuracy of blood pressure measurement using the Samsung Galaxy Smartwatch compared to a medical grade digital tonometer with a cuff placed on the arm.
- Conditions
- Hypertension, Blood Pressure
- Being tested
- Long-term non-invasive Blood pressure monitoring
- Keywords
- Smartwatch, Blood pressure, Heart rate
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Long-term non-invasive Blood pressure monitoringOther
Also called Long-term non-invasive Heart rate monitoring
All measurements during the experiment include only non-invasive Blood pressure and Heart rate measurements. Measurements will be taken using a smartwatch attached to the wrist and a digital tonometer with a cuff placed on the other arm. Paired readings will be compared.
| Study group | Role | What they receive |
|---|---|---|
| Long-term Blood pressure and Heart rate monitoring with reference digital tonometer and smartwatch | Experimental | Measurement of a non-invasive Blood pressure and Heart rate using a reference medical grade digital tonometer Omron and a smartwatch Samsung Galaxy Watch during 20-40 days every morning and evening. Receives: Other: Long-term non-invasive Blood pressure monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure agreement between smartwatch and digital tonometer
The agreement of Blood pressure measurements between smartwatch and medical grade reference digital tonometer
Measured: 20-40 days
Secondary outcomes (1)
Heart rate agreement between smartwatch and digital tonometer
The agreement of Heart rate measurements between smartwatch and medical grade reference digital tonometer
Measured: 20-40 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2023
- Study start13 Oct 2023
- Primary completion30 Oct 2025
- Study completion1 Nov 2025
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 HypertensionStudies 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
- Interventional prospective single-arm study
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Czech Technical University in Prague
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jakub Rafl, Principal investigator, Czech Technical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06098092
- Sponsor's protocol ID
- NVT_02_2023
- Acronym
- BPLONG
- Status last verified
- Mar 2026
- First submitted
- 9 Oct 2023
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The measured data will be shared publicly in the data repository on web page: https://ventilation.fbmi.cvut.cz/data/
Publications
Walzel S, Sebestova H, Rafl-Huttova V, Rozanek M, Rafl J. Long-term accuracy and stability of blood pressure measurements from a smartwatch: Prospective validation study. Digit Health. 2026 Jan 22;12:20552076261415923. doi: 10.1177/20552076261415923. eCollection 2026 Jan-Dec.
PubMed 41602947
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Experimental Validation of the Long-term Accuracy of Blood Pressure Measurement Using a Smartwatch
- ClinicalTrials.gov ID
- NCT06098092
- Acronym / sponsor ID
- BPLONG / NVT_02_2023
- Conditions
- Hypertension, Blood Pressure
- Keywords
- Smartwatch, Blood pressure, Heart rate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Czech Technical University in PragueUniversity, hospital or other
- Study start
- 13 Oct 2023 (actual)
- Primary completion
- 30 Oct 2025 (actual)
- Study completion
- 1 Nov 2025 (actual)
- First posted
- 24 Oct 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 perform an experimental validation of the long-term accuracy of blood pressure measurement using the Samsung Galaxy Smartwatch
Detailed description
Blood pressure is one of the basic vital signs monitored and is one of the most important indicators of a patient's health status. Cardiovascular disease is one of the leading causes of death worldwide. One of the major risk factors for cardiovascular disease is hypertension, which is globally attributed to one third of deaths in the world population. To improve the prevention of hypertension, self-monitoring of blood pressure is increasingly recommended. This project involves an experimental validation of the long-term accuracy of blood pressure measurement using the Samsung Galaxy Smartwatch compared to a medical grade digital tonometer with a cuff placed on the arm.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Interventional prospective single-arm study
| Arm | Type | Receives |
|---|---|---|
| Long-term Blood pressure and Heart rate monitoring with reference digital tonometer and smartwatch | Experimental | Other: Long-term non-invasive Blood pressure monitoringMeasurement of a non-invasive Blood pressure and Heart rate using a reference medical grade digital tonometer Omron and a smartwatch Samsung Galaxy Watch during 20-40 days every morning and evening. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy volunteer
Key exclusion criteria (13 listed)
- post-traumatic conditions of the upper limbs
- tattoos, birthmarks, injuries or diseases of the skin on the wrists of hands
- cardiac arrhythmias
- circulatory or peripheral varcular disease
- aortic valve disease
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 |
|---|---|---|
| Long-term non-invasive Blood pressure monitoringAlso: Long-term non-invasive Heart rate monitoringAll measurements during the experiment include only non-invasive Blood pressure and Heart rate measurements. Measurements will be taken using a smartwatch attached to the wrist and a digital tonometer with a cuff placed on the other arm. Paired readings will be compared. | Other | Long-term Blood pressure and Heart rate monitoring with reference digital tonometer and smartwatch |
Primary outcome
Blood pressure agreement between smartwatch and digital tonometer
Time frame: 20-40 days
The agreement of Blood pressure measurements between smartwatch and medical grade reference digital tonometer
1 secondary outcome
Heart rate agreement between smartwatch and digital tonometer
Time frame: 20-40 days
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 12 Mar 2026.
- Derived from this study: PubMed 41602947Walzel S, Sebestova H, Rafl-Huttova V, Rozanek M, Rafl J. Long-term accuracy and stability of blood pressure measurements from a smartwatch: Prospective validation study. Digit Health. 2026 Jan 22;12:20552076261415923. doi: 10.1177/20552076261415923. eCollection 2026 Jan-Dec.
- Individual participant dataSharing planned: Yes. The measured data will be shared publicly in the data repository on web page: https://ventilation.fbmi.cvut.cz/data/
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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 principal investigator
Czech Technical University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Long-term non-invasive Blood pressure monitoring in people with Hypertension and Blood Pressure, run by Czech Technical University in Prague at 2 sites 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 13 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 12 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 2 sites 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?
Blood pressure agreement between smartwatch and digital tonometer (time frame: 20-40 days). 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 NCT06098092, 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 12 Mar 2026.