Smartwatch ABPM vs. Conventional ABPM

Blood Pressure Clinical Trial

— SamsungWatch  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04553861
• Other study ID #: SamsungWatch
• Status: Completed
• Start date: November 1, 2020
• Est. completion date: March 1, 2021

Study information

• Verified date: April 2021
• Source: Wonju Severance Christian Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 1, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blood Pressure

Intervention

Device:
• Ambulatory blood pressure monitoring
Every 30 minutes from 7 AM to 10 PM and every 1 hour from 10 PM to 7 AM
• 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

Locations

Country	Name	City	State
Korea, Republic of	Wonju Severance Christian Hospital	Wonju	Gangwon-do

Sponsors (2)

Lead Sponsor	Collaborator
Wonju Severance Christian Hospital	Samsung Electronics

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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