Validation of a Smartwatch for Blood Pressure Monitoring (SmartBP)

February 25, 2025 updated by: European University Miguel de Cervantes

Validation of a Smartwatch for Blood Pressure Measurement

Accurate measurement of blood pressure is essential for the assessment of cardiovascular health and the prevention of cardiovascular disease. Smartwatches have emerged as a promising option for continuous monitoring of blood pressure outside the clinical setting. This study aims to validate the use of the smartwatch KC08 for blood pressure measurement, which is a cost-effective and convenient alternative for blood pressure measurement. A cross-sectional study will be conducted with participants aged greater than or equal to18 years. The measurements of blood pressure, heart rate and oxygen saturation will be performed with the smartwatch KC08, the Beurer PO30 pulse oximeter and the Omron M7 BP monitor. The statistical analysis will evaluate the reliability of the devices and compare the measurements of the two devices using different statistical methods.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

101

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Castilla Y León
      • Valladolid, Castilla Y León, Spain, 47012
        • European University Miguel de Cervantes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Observational cross-sectional study with participants at least 18 years of age. Participants will be recruited from the European University Miguel de Cervantes. Once the protocol has been explained and the informed consent has been signed, measurements will be taken.

Description

Inclusion Criteria:

  • Be ≥18 years old and able to understand the informed consent.

Exclusion Criteria:

  • A difference of ≥20 mmHg in systolic and/or diastolic blood pressure between both arms.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Descriptive
A single population is used to estimate blood pressure, heart rate and oxygen saturation in order to study and validate the use of the KC08 smartwatch.
Device: Use of the KC08 smartwatch, Beurer PO30 and Omron M7 BP monitor.
Use of the KC08 smartwatch, Beurer PO30 and Omron M7 BP monitor to estimate blood pressure, heart rate and oxygen saturation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diastolic and systolic blood pressure
Time Frame: 5 minutes rest; 5 minutes safety BP measurements of both arms; 30 minutes BP measurements (10 measurements in total)
For BP measurement, an Omron M7 automatic blood pressure monitor (Omron Healthcare Co., Ltd., Kyoto, Japan) and a KC08 smartwatch (Mediatek Inc., Hsinchu, Taiwan) will be used. The participant should sit in a comfortable chair with lumbar support for at least 5 minutes prior to the measurement. The participant will be asked to place both feet flat on the floor, without crossing the legs, and rest the arm with the cuff on a table at chest level, palm up. Ensuring that the cuff is properly adjusted but not too tight and in contact with bare skin, the blood pressure will be measured. During this process, the subject should refrain from talking to ensure an accurate and reliable reading. The values obtained will be recorded according to standard blood pressure measurement procedures. 10 measurements separated by 1 minute will be taken with each device. The BP results will be recorded in mmHg.
5 minutes rest; 5 minutes safety BP measurements of both arms; 30 minutes BP measurements (10 measurements in total)
Heart rate
Time Frame: 30 minutes (10 measurements in total)

An Omron M7 automatic blood pressure monitor (Omron Healthcare Co., Ltd., Kyoto, Japan), a Beuer PO30 pulse oximeter and a KC08 smartwatch (Mediatek Inc., Hsinchu, Taiwan) will be used. Heart rate will be recorded while blood pressure measurements are being recorded.

10 measurements separated by 1 minute will be taken with each device. The heart rate results will be recorded in beats per minute (bpm).
30 minutes (10 measurements in total)
Peripheral oxygen saturation
Time Frame: 30 minutes (10 measurements in total)
A Beurer PO30 pulse oximeter (Beurer GmbH, Mittelstand, Germany) and a KC08 smartwatch (Mediatek Inc., Hsinchu, Taiwan) will be used. 10 measurements separated by 1 minute will be taken with each device. The peripheral oxygen saturation results will be recorded in percentage of hemoglobin saturation.
30 minutes (10 measurements in total)
Physical activity levels
Time Frame: 2 minutes

Participants' physical activity levels will be assessed using the International Physical Activity Questionnaire (IPAQ). This questionnaire consists of 7 questions that will help us stratify physical activity levels.

It is used as a descriptive measure of the users and a possible confounding factor. It takes approximately 2 minutes to complete the questionnaire and we do it in the initial interview, before starting with the measurements of BP, heart rate and peripheral oxygen saturation.
2 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European University Miguel de Cervantes

Collaborators

Valladolid University Clinical Hospital. Cardiology Department.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 10, 2024

Primary Completion (Actual)

November 21, 2024

Study Completion (Actual)

November 21, 2024

Study Registration Dates

First Submitted

October 3, 2024

First Submitted That Met QC Criteria

October 3, 2024

First Posted (Actual)

October 4, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 25, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PI-DOC007_SmartBP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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