Blood PressureNCT05401435
Reliability of Measuring Blood Pressure With a Smartwatch
A study testing Resting measurement of blood pressure and heart rate 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 long-term accuracy of blood pressure and heart rate measurements by Samsung smartwatches between two consecutive calibrations compared to a standard digital tonometer used in clinical practice and for home measurement of these vital parameters. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure, Heart Rate
- What is being tested?
- Resting measurement of blood pressure and heart rate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteCzechia
- Study dates
- 4 May 2022to 30 Sep 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- 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, 1 recruiting
- Recruiting
Faculty of Biomedical Engineering, Czech Technical University in Prague
Kladno, 27201
Barbora Nezpevakova, Bc, +420728096216, nezpebar@fbmi.cvut.cz
Veronika Rafl Huttova, MSc, huttover@fbmi.cvut.cz
About this study
The aim of this study is to verify the long-term accuracy of blood pressure and heart rate measurements by Samsung smartwatches between two consecutive calibrations compared to a standard digital tonometer used in clinical practice and for home measurement of these vital parameters.
Read the detailed description
Recently, smartwatches can measure a wide range of biological signals, including heart rate and blood pressure. The short-term reliability of blood pressure measurements after the required calibration has been studied, but long-term reliability is still a question. The aim of the project is to experimentally evaluate the reliability of long-term blood pressure measurement with a Samsung smart watch between two consecutive calibrations over a period of 28 days in comparison with a digital tonometer (Omron) approved as a medical device. Volunteers will measure blood pressure and heart rate manually twice a day from a smartwatch and a digital tonometer simultaneously. The agreement of the measurements of both devices will be evaluated.
- Conditions
- Blood Pressure, Heart Rate
- Being tested
- Resting measurement of blood pressure and heart rate
- 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.
Resting measurement of blood pressure and heart rateOther
Simultaneous blood pressure and heart rate measurement every morning and evening during the duration of the experiment (28 days).
| Study group | Role | What they receive |
|---|---|---|
| Blood pressure and heart rate measurement | Experimental | Resting blood pressure and heart rate measurement regularly one value in the morning and evening for 28 days. The volunteer measures the parameters simultaneously on both devices (smartwatch and digital tonometer). In total, each participant will undergo this measurement 56 times. Receives: Other: Resting measurement of blood pressure and heart rate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in long-term similarity of blood pressure measurements from two devices between two consecutive calibrations
The long-term agreement of systolic and diastolic blood pressure measurements of both monitoring devices between two consecutive smartwatch calibrations will be evaluated. This means that we evaluate the changes in the similarity of measured blood pressures over a period of 28 days.
Measured: 28 days
Change in long-term similarity of heart rate measurements from two devices
The long-term agreement of heart rate measurements of both monitoring devices will be evaluated. This means that we evaluate the changes in the similarity of measured heart rates over a period of 28 days.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2022
- Study start4 May 2022
- Primary completion30 Sep 2022 (estimated)
- Study completion30 Sep 2022 (estimated)
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 single measurement of blood pressure and heart rate on each participant. Measurements are repeated 2 times a day for 28 days. The functioning of two measuring devices is compared.
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Czech Technical University in Prague
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Barbora Nezpevakova, Bc., Principal investigator, Czech Technical University in PragueVeronika Rafl Huttova, MSc, Principal investigator, Czech Technical University in PragueMartin Rozanek, PhD, Principal investigator, Czech Technical University in PragueJakub Rafl, PhD, Principal investigator, Czech Technical University in Prague
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05401435
- Sponsor's protocol ID
- NIBPsmartwatch22
- Status last verified
- Jun 2022
- First submitted
- 23 May 2022
- Last updated
- 2 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
van Helmond N, Freeman CG, Hahnen C, Haldar N, Hamati JN, Bard DM, Murali V, Merli GJ, Joseph JI. The accuracy of blood pressure measurement by a smartwatch and a portable health device. Hosp Pract (1995). 2019 Oct;47(4):211-215. doi: 10.1080/21548331.2019.1656991. Epub 2019 Aug 26.
PubMed 31423912
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability of Measuring Blood Pressure With a Smartwatch
- ClinicalTrials.gov ID
- NCT05401435
- Acronym / sponsor ID
- NIBPsmartwatch22
- Conditions
- Blood Pressure, Heart Rate
- Keywords
- blood pressure measurement, heart rate measurement, smartwatch
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Czech Technical University in PragueUniversity, hospital or other
- Study start
- 4 May 2022 (actual)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 2 Jun 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 long-term accuracy of blood pressure and heart rate measurements by Samsung smartwatches between two consecutive calibrations compared to a standard digital tonometer used in clinical practice and for home measurement of these vital parameters.
Detailed description
Recently, smartwatches can measure a wide range of biological signals, including heart rate and blood pressure. The short-term reliability of blood pressure measurements after the required calibration has been studied, but long-term reliability is still a question. The aim of the project is to experimentally evaluate the reliability of long-term blood pressure measurement with a Samsung smart watch between two consecutive calibrations over a period of 28 days in comparison with a digital tonometer (Omron) approved as a medical device. Volunteers will measure blood pressure and heart rate manually twice a day from a smartwatch and a digital tonometer 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 single measurement of blood pressure and heart rate on each participant. Measurements are repeated 2 times a day for 28 days. The functioning of two measuring devices is compared.
| Arm | Type | Receives |
|---|---|---|
| Blood pressure and heart rate measurement | Experimental | Other: Resting measurement of blood pressure and heart rateResting blood pressure and heart rate measurement regularly one value in the morning and evening for 28 days. The volunteer measures the parameters simultaneously on both devices (smartwatch and digital tonometer). In total, each participant will undergo this measurement 56 times. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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 |
|---|---|---|
| Resting measurement of blood pressure and heart rateSimultaneous blood pressure and heart rate measurement every morning and evening during the duration of the experiment (28 days). | Other | Blood pressure and heart rate measurement |
Primary outcome
Change in long-term similarity of blood pressure measurements from two devices between two consecutive calibrations
Time frame: 28 days
The long-term agreement of systolic and diastolic blood pressure measurements of both monitoring devices between two consecutive smartwatch calibrations will be evaluated. This means that we evaluate the changes in the similarity of measured blood pressures over a period of 28 days.
Change in long-term similarity of heart rate measurements from two devices
Time frame: 28 days
The long-term agreement of heart rate measurements of both monitoring devices will be evaluated. This means that we evaluate the changes in the similarity of measured heart rates over a period of 28 days.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2022.
- Background: PubMed 31423912van Helmond N, Freeman CG, Hahnen C, Haldar N, Hamati JN, Bard DM, Murali V, Merli GJ, Joseph JI. The accuracy of blood pressure measurement by a smartwatch and a portable health device. Hosp Pract (1995). 2019 Oct;47(4):211-215. doi: 10.1080/21548331.2019.1656991. Epub 2019 Aug 26.
- Individual participant dataSharing planned: No
Related trials for Blood Pressure
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
RecruitingPhase 3
A Phase III Renal Outcomes and Cardiovascular Mortality Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin in Participants With Chronic Kidney Disease and High Blood Pressure
Chronic Kidney Disease and Hypertension
Recruiting
Guiding Optimal Blood Pressure Management in Peritoneal Dialysis Pilot Trial
End Stage Kidney Disease (ESKD), Hypertension (HTN)
RecruitingPhase 4
Hematological Safety of Dipyrone Versus Paracetamol After Dental Extractions
Hematologic Test, Agranulocytosis
Not yet recruiting
Acute Effects of Mat Pilates on Blood Pressure Response to Mental Stress in Higher Education Teachers
Behavior
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.
Barbora Nezpevakova, Bc. principal investigator
Czech Technical University in Prague
Veronika Rafl Huttova, MSc 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 Resting measurement of blood pressure and heart rate 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: status not confirmed, as of the sponsor's last update on 2 Jun 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Barbora Nezpevakova, Bc. (+420728096216, nezpebar@fbmi.cvut.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in long-term similarity of blood pressure measurements from two devices between two consecutive calibrations (time frame: 28 days). 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 NCT05401435, 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 2 Jun 2022.