Validation of a Smartwatch for Blood Pressure Monitoring

NCT06627920 | Completed

• 1 other identifier: PI-DOC007_SmartBP
• Study Type: observational
• Target: 101
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Blood Pressure; Heart Rate; Oxygen Saturation

Keywords

cardiovascular health; wearable devices; blood pressure

Outcome Measures

Primary Outcomes (4)

• Diastolic and systolic blood pressure

  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

  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

  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

  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

Study Arms (1)

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.

Interventions

Use of the KC08 smartwatch, Beurer PO30 and Omron M7 BP monitor. DEVICE

Use of the KC08 smartwatch, Beurer PO30 and Omron M7 BP monitor to estimate blood pressure, heart rate and oxygen saturation.

Descriptive

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• European University Miguel de Cervantes: lead
• Valladolid University Clinical Hospital. Cardiology Department.: collaborator

Study Sites (1)

European University Miguel de Cervantes

Valladolid, Castille and León, 47012, Spain

Location

Related Publications (10)

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  PMID: 30165516 BACKGROUND

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  PMID: 15702453 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2024
• First Posted: October 4, 2024
• Study Start: July 10, 2024
• Primary Completion: November 21, 2024
• Study Completion: November 21, 2024
• Last Updated: February 27, 2025

Record last verified: 2025-02

Locations

ES (1)