Wearable Blood-Pressure Monitoring Comparison Study

NCT07719660 | Not Yet Recruiting

• 1 other identifier: BO ff (Mono)-EK-475112025
• Study Type: observational
• Target: 120
• Locations: 2 countries
• Sites: 2

Brief 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. 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,

Conditions

Hypertension; Blood Pressure Monitoring; Wearable Devices; Photoplethysmography; Cuff

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Cohort at general ward

Cohort at ICU

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Technische Universität Dresden: lead
• Careggi Hospital: collaborator

Study Sites (2)

University Hospital Dresden

Dresden, Saxony, 01307, Germany

Location

Careggi University Hospital

Florence, FI, 50134, Italy

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Moritz Herzog, MD

CONTACT

0049 351 458 11501; moritz.herzog@ukdd.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 18, 2026
• First Posted: July 22, 2026
• Study Start: July 20, 2026
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 23, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: after finishing the study, data will be stored locally for at least 10 years
• Access Criteria: contact the investigators via mail

Locations

DE (1); IT (1)