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NCT Number: NCT07719660

Wearable Blood-Pressure Monitoring Comparison Study

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,

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Key information

Age range

21 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Dresden, Dresden, Saxony, Germany

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Moritz Herzog, MD

CONTACT

[email protected]

0049 351 458 11501

Sponsors and collaborators

Lead sponsor

Technische Universität Dresden

Other

Collaborators

  • Careggi Hospital

Registry information

Official study title

Wearable Blood-Pressure Monitoring Comparison Study (WBPMCS)

Acronym: WBPMCS

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 22, 2026
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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