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Validation of a Smartwatch for Blood Pressure Monitoring (SmartBP)

E

European University Miguel de Cervantes

Status

Completed

Conditions

Oxygen Saturation
Heart Rate
Blood Pressure

Treatments

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

Study type

Observational

Funder types

Other

Identifiers

NCT06627920
PI-DOC007_SmartBP

Details and patient eligibility

About

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.

Enrollment

101 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

101 participants in 1 patient group

Descriptive
Description:
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.
Treatment:
Device: Use of the KC08 smartwatch, Beurer PO30 and Omron M7 BP monitor.

Trial contacts and locations

1

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Central trial contact

Susana López Ortiz, PhD; Pablo Elpidio García Granja, PhD, MD

Data sourced from clinicaltrials.gov

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