HypertensionWBPMCSNCT07719660
Wearable Blood-Pressure Monitoring Comparison Study
An observational study of Hypertension and Blood Pressure Monitoring, run by Technische Universität Dresden at 2 sites in 2 countries.
Trial summary
The goal of this clinical trial is to compare the accuracy, clinical applicability, and usability of different wearable blood pressure monitoring methods integrated in wearable devices, such as smartwatches, in hospitalized patients. Read more about this study
- Who is it for?
- Ages 21 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Blood Pressure Monitoring, Wearable Devices
- How many people
- 120 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 20 Jul 2026to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 21 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Hospitalized adult patients aged 21 to 85 years who are treated on participating general wards or intensive care units at the hospital and are able to provide written informed consent.
Who may be able to join
- Blood pressure measurements can be performed on at least one arm, for example no amputation, dialysis shunt, or obstructive dressing
- Ability to understand the study information and provide written informed consent
- For participants in the intensive care unit: an arterial line placed for clinical reasons
Who cannot join
- Wrist circumference exceeds the size range of the investigated wearable devices
- Physical or medical conditions preventing placement of the wearable devices, including relevant skin lesions, wounds, severe edema, or patient restraint
- Inability to provide written informed consent
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Germany1 site, 1 recruiting
- Recruiting
University Hospital Dresden
Dresden, Saxony, 01307
Italy1 site, 1 recruiting
- Not yet recruiting
Careggi University Hospital
Florence, FI, 50134
About this study
Official title: Wearable Blood-Pressure Monitoring Comparison Study (WBPMCS)
The goal of this clinical trial is to compare the accuracy, clinical applicability, and usability of different wearable blood pressure monitoring methods integrated in wearable devices, such as smartwatches, in hospitalized patients. The study evaluates novel photoplethysmography (PPG)-based and wrist-oscillometric blood pressure measurement methods against established clinical reference methods (upper-arm cuff measurements on the general ward and invasive arterial blood pressure monitoring (A-line) in the intensive care unit).
The main questions the study aims to answer are:
Read more
- Can novel blood pressure monitoring methods suitable for integration into wearable devices achieve clinically acceptable agreement with established reference measurements?
- How does the performance of calibration-dependent wearable devices change over time following calibration?
- How does the performance of the investigated methods compare with each other?
- How do the investigated methods perform for patients with different pre-existing conditions ?
To answer these questions, participants will undergo:
- blood pressure measurements using different wearable devices based on PPG and wrist oscillometry
- standardized reference blood pressure measurements using an upper-arm cuff (general ward) or an existing invasive arterial line (intensive care unit)
- repeated measurements over three consecutive days on the general ward to assess calibration stability and measurement reproducibility,
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort at general ward | Not described | |
| Cohort at ICU | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement of wearable blood pressure measurement methods with clinical reference measurements
The mean difference and standard deviation of the differences in systolic and diastolic blood pressure, expressed in mmHg, between each investigated wearable blood pressure measurement method and the corresponding reference method.
Measured: General ward: At each measurement session on study days 1, 2, and 3. ICU: At measurement session on study day 1, approx. 2 hours after device calibration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2026
- Study start20 Jul 2026
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Collaborators
- Careggi Hospital
- Responsible party
- Principal investigator, Moritz Herzog, Technische Universität Dresden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07719660
- Sponsor's protocol ID
- BO ff (Mono)-EK-475112025
- Acronym
- WBPMCS
- Status last verified
- Jul 2026
- First submitted
- 18 Jul 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We plan to provide the anonymized IPD after publication.
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wearable Blood-Pressure Monitoring Comparison Study (WBPMCS)
- ClinicalTrials.gov ID
- NCT07719660
- Acronym / sponsor ID
- WBPMCS / BO ff (Mono)-EK-475112025
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Collaborators
- Careggi Hospital
- Study start
- 20 Jul 2026 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 22 Jul 2026 (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 goal of this clinical trial is to compare the accuracy, clinical applicability, and usability of different wearable blood pressure monitoring methods integrated in wearable devices, such as smartwatches, in hospitalized patients. The study evaluates novel photoplethysmography (PPG)-based and wrist-oscillometric blood pressure measurement methods against established clinical reference methods (upper-arm cuff measurements on the general ward and invasive arterial blood pressure monitoring (A-line) in the intensive care unit).
The main questions the study aims to answer are:
- Can novel blood pressure monitoring methods suitable for integration into wearable devices achieve clinically acceptable agreement with established reference measurements?
- How does the performance of calibration-dependent wearable devices change over time following calibration?
- How does the performance of the investigated methods compare with each other?
- How do the investigated methods perform for patients with different pre-existing conditions ?
To answer these questions, participants will undergo:
- blood pressure measurements using different wearable devices based on PPG and wrist oscillometry
- standardized reference blood pressure measurements using an upper-arm cuff (general ward) or an existing invasive arterial line (intensive care unit)
- repeated measurements over three consecutive days on the general ward to assess calibration stability and measurement reproducibility,
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort at general ward | – | – |
| Cohort at ICU | – | – |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Hospitalized adult patients aged 21 to 85 years who are treated on participating general wards or intensive care units at the hospital and are able to provide written informed consent.
Key inclusion criteria (3 listed)
- Blood pressure measurements can be performed on at least one arm, for example no amputation, dialysis shunt, or obstructive dressing
- Ability to understand the study information and provide written informed consent
- For participants in the intensive care unit: an arterial line placed for clinical reasons
Key exclusion criteria (3 listed)
- Wrist circumference exceeds the size range of the investigated wearable devices
- Physical or medical conditions preventing placement of the wearable devices, including relevant skin lesions, wounds, severe edema, or patient restraint
- Inability to provide written informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Agreement of wearable blood pressure measurement methods with clinical reference measurements
Time frame: General ward: At each measurement session on study days 1, 2, and 3. ICU: At measurement session on study day 1, approx. 2 hours after device calibration
The mean difference and standard deviation of the differences in systolic and diastolic blood pressure, expressed in mmHg, between each investigated wearable blood pressure measurement method and the corresponding reference method.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Individual participant dataSharing planned: Yes. We plan to provide the anonymized IPD after publication.
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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.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension and Blood Pressure Monitoring, run by Technische Universität Dresden at 2 sites in 2 countries.
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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 26 Aug 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 Germany, Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Moritz Herzog, MD (0049 351 458 11501, moritz.herzog@ukdd.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement of wearable blood pressure measurement methods with clinical reference measurements (time frame: General ward: At each measurement session on study days 1, 2, and 3. ICU: At measurement session on study day 1, approx. 2 hours after device calibration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Aug 2026.