Wearable Blood-Pressure Monitoring Comparison Study (WBPMCS)

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:

• 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 Overview

• Status: Not yet recruiting
• Conditions: Hypertension; Cuff; Wearable Devices; Photoplethysmography; Blood Pressure Monitoring

• Study Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

• Study Contact: Name: Moritz Herzog, MD; Phone Number: 0049 351 458 11501; Email: moritz.herzog@ukdd.de

Study Locations

• Germany
  • Saxony
    • Dresden, Saxony, Germany, 01307
      • University Hospital Dresden
• Italy
  • FI
    • Florence, FI, Italy, 50134
      • Careggi University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Cohort at general ward
Cohort at ICU

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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

Collaborators and Investigators

• Sponsor: Technische Universität Dresden
• Collaborators: Careggi Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): July 20, 2026
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: July 18, 2026
• First Submitted That Met QC Criteria: July 18, 2026
• First Posted (Actual): July 22, 2026

Study Record Updates

• Last Update Posted (Actual): July 23, 2026
• Last Update Submitted That Met QC Criteria: July 22, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypertension
• Other Study ID Numbers: BO ff (Mono)-EK-475112025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We plan to provide the anonymized IPD after publication.
• IPD Sharing Time Frame: after finishing the study, data will be stored locally for at least 10 years
• IPD Sharing Access Criteria: contact the investigators via mail
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No