Validation of a Smartwatch for Blood Pressure Monitoring

Completed

• Conditions: Blood Pressure; Heart Rate; Oxygen Saturation
• Interventions: Device: Use of the KC08 smartwatch, Beurer PO30 and Omron M7 BP monitor.

• Registration Number: NCT06627920
• Lead Sponsor: European University Miguel de Cervantes

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-10
• Study First Submitted: 2024-10-03
• Study First Submitted QC: 2024-10-03
• Study First Posted: 2024-10-04
• Primary Completion: 2024-11-21
• Study Completion: 2024-11-21
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-25
• Last Update Posted: 2025-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Descriptive	Use of the KC08 smartwatch, Beurer PO30 and Omron M7 BP monitor.	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.

Primary Outcome Measures

Name	Time	Method
Diastolic and systolic blood pressure	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.
Peripheral oxygen saturation	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.
Physical activity levels	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.
Heart rate	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).

Trial Locations

Locations (1)

European University Miguel de Cervantes; 🇪🇸 Valladolid, Castilla Y León, Spain