Clinical trial NCT06627920: Validation of a Smartwatch for Blood Pressure Monitoring
Official title: Validation of a Smartwatch for Blood Pressure Measurement
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Blood Pressure
Heart Rate
Oxygen Saturation
Keywords: cardiovascular health
wearable devices
blood pressure
Lead sponsor: European University Miguel de Cervantes
Sponsor class: OTHER
Collaborators: name: Valladolid University Clinical Hospital. Cardiology Department.
First posted: 2024-10-04
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Diastolic and systolic blood pressure
timeFrame: 5 minutes rest; 5 minutes safety BP measurements of both arms; 30 minutes BP measurements (10 measurements in total)
measure: Heart rate
timeFrame: 30 minutes (10 measurements in total)
measure: Peripheral oxygen saturation
timeFrame: 30 minutes (10 measurements in total)
measure: Physical activity levels
timeFrame: 2 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Valladolid
country: Spain
facility: European University Miguel de Cervantes
state: Castilla Y León
Study officials:
References:
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