Reliability of Measuring Blood Pressure With a Smartwatch

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.

Study Overview

• Status: Recruiting
• Conditions: Blood Pressure; Heart Rate
• Intervention / Treatment: Other: Resting measurement of blood pressure and heart rate

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Veronika Rafl Huttova, MSc; Phone Number: +420224355049; Email: huttover@fbmi.cvut.cz
• Study Contact Backup: Name: Barbora Nezpevakova, Bc.; Phone Number: +420728096216; Email: nezpebar@fbmi.cvut.cz

Study Locations

• Czechia
  • Kladno, Czechia, 27201
    • Recruiting
    • Faculty of Biomedical Engineering, Czech Technical University in Prague
    • Contact: Veronika Rafl Huttova, MSc; Email: huttover@fbmi.cvut.cz
    • Contact: Barbora Nezpevakova, Bc; Phone Number: +420728096216; Email: nezpebar@fbmi.cvut.cz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• healthy volunteers

Exclusion Criteria:

• any acute illness
• pregnancy
• severe cardiovascular conditions
• severe asthma or other severe respiratory conditions
• diabetes
• hypotension or hypertension

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Blood pressure and heart rate measurement; Resting blood pressure and heart rate measurement regularly one value in the morning and evening for 28 days. The volunteer measures the parameters simultaneously on both devices (smartwatch and digital tonometer). In total, each participant will undergo this measurement 56 times.	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Czech Technical University in Prague
• Investigators: Principal Investigator: Veronika Rafl Huttova, MSc, Czech Technical University in Prague; Principal Investigator: Jakub Rafl, PhD, Czech Technical University in Prague; Principal Investigator: Martin Rozanek, PhD, Czech Technical University in Prague; Principal Investigator: Barbora Nezpevakova, Bc., Czech Technical University in Prague

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 4, 2022
• Primary Completion (Anticipated): September 30, 2022
• Study Completion (Anticipated): September 30, 2022

Study Registration Dates

• First Submitted: May 23, 2022
• First Submitted That Met QC Criteria: June 1, 2022
• First Posted (Actual): June 2, 2022

Study Record Updates

• Last Update Posted (Actual): June 2, 2022
• Last Update Submitted That Met QC Criteria: June 1, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: smartwatch; blood pressure measurement; heart rate measurement
• Other Study ID Numbers: NIBPsmartwatch22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No