Non-invasive Blood Pressure Measurement Using Samsung Smartwatch

Blood Pressure Clinical Trial

Official title:

Non-invasive Blood Pressure Measurement Using Samsung Smartwatch

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05302193
• Other study ID #: NIBPsmartwatch21
• Status: Recruiting
• Phase: N/A
• Start date: February 15, 2022
• Est. completion date: June 30, 2022

Study information

• Verified date: March 2022
• Source: Czech Technical University in Prague
• Contact: Veronika Rafl Huttova, MSc
• Phone: +420224355049
• Email: huttover[@]fbmi.cvut.cz
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to verify the accuracy of blood pressure and heart rate measurement by Samsung smartwatches compared to a standard monitor of vital signs used in intensive care units.

Description:

Recently, wearables, like smartwatches, have been gaining new possibilities in monitoring biological signals and they are used for home monitoring of health conditions. Heart rate measurement is a common function of smartwatches, some smartwatch models even measure blood pressure. The study aims to compare the measurement of blood pressure and heart rate using the latest smartwatch with a vital signs monitor used in clinical practice. Blood pressure and heart rate measurements will be taken by hand from the watch and the vital signs monitor simultaneously. The agreement of the measurements of both devices will be evaluated.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years and older

Eligibility

Inclusion Criteria:

• healthy volunteers

Exclusion Criteria:

• any acute illness

• pregnancy

• severe cardiovascular conditions

• severe asthma or other severe respiratory conditions

• diabetes

• hypotension or hypertension

Related Conditions & MeSH terms

• Blood Pressure
• Heart Rate

Intervention

Other:
• Calm measurement of blood pressure and heart rate (before physical activity)
Simultaneous blood pressure and heart rate measurements at minutes 2 and 5.5 of the experiment.
• Physical activity
Five minutes of physical activity, between times 7.5 min and 12.5 min of the experimental part. Riding on a spinning ergometer with a standardized load of 1 W/kg.
• Calm measurement of blood pressure and heart rate (after physical activity)
Simultaneous blood pressure and heart rate measurements at times 15.5, 17, 20.5 and 22 minutes of the experimental part.

Locations

Country	Name	City	State
Czechia	Faculty of Biomedical Engineering, Czech Technical University in Prague	Kladno

Sponsors (1)

Lead Sponsor	Collaborator
Czech Technical University in Prague

Country where clinical trial is conducted

Czechia, 

References & Publications (1)

Hahnen C, Freeman CG, Haldar N, Hamati JN, Bard DM, Murali V, Merli GJ, Joseph JI, van Helmond N. Accuracy of Vital Signs Measurements by a Smartwatch and a Portable Health Device: Validation Study. JMIR Mhealth Uhealth. 2020 Feb 12;8(2):e16811. doi: 10.2196/16811. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Similarity of blood pressure measurements from two devices	The agreement of systolic and diastolic blood pressure measurements of both monitoring devices will be evaluated.	1 hour
Primary	Similarity of heart rate measurements from two devices	The agreement of heart rate measurements of both monitoring devices will be evaluated.	1 hour