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NCT Number: NCT06627920

Validation of a Smartwatch for Blood Pressure Monitoring

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.

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Key information

Conditions

Blood Pressure Heart Rate Oxygen Saturation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

European University Miguel de Cervantes

Valladolid, Castille and León, 47012, Spain

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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).

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

European University Miguel de Cervantes

Other

Collaborators

  • Valladolid University Clinical Hospital. Cardiology Department.

Registry information

Official study title

Validation of a Smartwatch for Blood Pressure Measurement

Acronym: SmartBP

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Oct 4, 2024
Registry last updated
Feb 27, 2025

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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