Smartwatch ABPM vs. Conventional ABPM (SamsungWatch)

Correlation Between Smartwatch-based Blood Pressure Monitoring and Conventional Ambulatory Blood Pressure Monitoring

This study aims to investigate the accuracy and precision of the Samsung Smartwatch with conventional ambulatory blood pressure monitoring in healthy volunteers.

Study Overview

• Status: Completed
• Conditions: Blood Pressure
• Intervention / Treatment: Device: Ambulatory blood pressure monitoring; Device: Galaxy Watch Active2

Detailed Description

Blood pressure (BP) monitoring outside of the medical care environment is an increasingly important part of clinical hypertension assessment and management. Ambulatory BP monitoring (ABPM) uses automatic detection and recording devices for repeated determinations during an extended period, typically 24 hours. This technique has been shown to substantially enhance the clinician's understanding of BP behavior in patients and aid in diagnosis and therapeutic decision making. The ABPM is superior to office BP in predicting target organ, hypertensive cerebrovascular disease, retinopathy, renal abnormalities, and alterations in vascular compliance.1-4) Most of these studies have also demonstrated that a loss of nocturnal decline in BP (so-called non-dipper) conveys excessive risk for stroke and myocardial infarction.

Although conventional ABMP is usually well tolerated by patients, a few problems do exist. A minority of patients do not sleep well with the recorders and tend to have somewhat higher BP values. Cuffs can also rotate, and different arm positions can change BP significantly. Rarely, patients may develop erythema, ecchymoses, petechiae, or superficial phlebitis in the area distal to cuff placement.

Recently, smartwatches that measure BP without a cuff have become available. Since these measurements are relatively more user-friendly than conventional cuff-based measurements, they may aid in more frequent BP monitoring. Currently, only one study compared a non-commercial armband wearable pulse transit time (PTT) system for 24-hour cuff-less BP measurement with ABPM.5) We will investigate the accuracy and precision of Samsung Smartwatch with ABPM in young, healthy volunteers.

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gangwon-do
    • Wonju, Gangwon-do, Korea, Republic of, 26426
      • Wonju Severance Christian Hospital

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Healthy subjects willing to participate in this trial

Description

Inclusion criteria

• Ambulatory healthy subjects
• Subjects aged 20 years or more
• Subjects willing to participate in this study voluntarily Exclusion criteria
• Subjects inability to provide informed consent
• Subjects with any medical history
• Subjects with irregular heart rhythm (e.g. atrial fibrillation, atrial flutter, or bigeminy)
• Subjects unable to wear a watch due to wrist circumference
• Subjects with BP difference 10mmHg or more between left and right arm

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy subjects; Healthy subjects without blood pressure difference on both arm	Device: Ambulatory blood pressure monitoring; Every 30 minutes from 7 AM to 10 PM and every 1 hour from 10 PM to 7 AM; Device: Galaxy Watch Active2; Every 1 hour by subject (on-demand) from 7 AM to 10 PM and every 5 minutes (automatic) from 10 PM to 7 AM

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean nighttime blood pressure	Correlation of mean nighttime BP between the ABPM and the BP using the smartwatch	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Every time point blood pressure	BP differences between the ABPM and the BP using the smartwatch at every time point of measurement	Baseline
Mean 24-hour blood pressure	Correlation of mean 24-h BP between the ABPM and the BP using the smartwatch	Baseline
Mean daytime blood pressure	Correlation of mean daytime BP between the ABPM and the BP using the smartwatch	Baseline
Nighttime dipping	Correlation of nighttime dipping between the ABPM and the BP using the smartwatch	Baseline
Morning blood pressure	Correlation of morning BP between the ABPM and the BP using the smartwatch	Baseline

Collaborators and Investigators

• Sponsor: Wonju Severance Christian Hospital
• Collaborators: Samsung Electronics
• Investigators: Principal Investigator: Young Jin Youn, MD, PhD, Wonju Severance Christian Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2020
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): March 1, 2021

Study Registration Dates

• First Submitted: September 11, 2020
• First Submitted That Met QC Criteria: September 11, 2020
• First Posted (Actual): September 18, 2020

Study Record Updates

• Last Update Posted (Actual): April 8, 2021
• Last Update Submitted That Met QC Criteria: April 5, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Blood Pressure; Smartwatch; Ambulatory blood pressure monitoring
• Other Study ID Numbers: SamsungWatch

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