Reliability of Measuring Blood Pressure With a Smartwatch

Blood Pressure Clinical Trial

Official title:

Reliability of Measuring Blood Pressure With a Smartwatch

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05401435
• Other study ID #: NIBPsmartwatch22
• Status: Recruiting
• Phase: N/A
• Start date: May 4, 2022
• Est. completion date: September 30, 2022

Study information

• Verified date: June 2022
• Source: Czech Technical University in Prague
• Contact: Barbora Nezpevakova, Bc.
• Phone: +420728096216
• Email: nezpebar[@]fbmi.cvut.cz
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to verify the long-term accuracy of blood pressure and heart rate measurements by Samsung smartwatches between two consecutive calibrations compared to a standard digital tonometer used in clinical practice and for home measurement of these vital parameters.

Description:

Recently, smartwatches can measure a wide range of biological signals, including heart rate and blood pressure. The short-term reliability of blood pressure measurements after the required calibration has been studied, but long-term reliability is still a question. The aim of the project is to experimentally evaluate the reliability of long-term blood pressure measurement with a Samsung smart watch between two consecutive calibrations over a period of 28 days in comparison with a digital tonometer (Omron) approved as a medical device. Volunteers will measure blood pressure and heart rate manually twice a day from a smartwatch and a digital tonometer simultaneously. The agreement of the measurements of both devices will be evaluated.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: September 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 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:
• Resting measurement of blood pressure and heart rate
Simultaneous blood pressure and heart rate measurement every morning and evening during the duration of the experiment (28 days).

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)

van Helmond N, Freeman CG, Hahnen C, Haldar N, Hamati JN, Bard DM, Murali V, Merli GJ, Joseph JI. The accuracy of blood pressure measurement by a smartwatch and a portable health device. Hosp Pract (1995). 2019 Oct;47(4):211-215. doi: 10.1080/21548331.2019.1656991. Epub 2019 Aug 26. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in long-term similarity of blood pressure measurements from two devices between two consecutive calibrations	The long-term agreement of systolic and diastolic blood pressure measurements of both monitoring devices between two consecutive smartwatch calibrations will be evaluated. This means that we evaluate the changes in the similarity of measured blood pressures over a period of 28 days.	28 days
Primary	Change in long-term similarity of heart rate measurements from two devices	The long-term agreement of heart rate measurements of both monitoring devices will be evaluated. This means that we evaluate the changes in the similarity of measured heart rates over a period of 28 days.	28 days