NCT04553861

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 11, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 18, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

April 8, 2021

Status Verified

April 1, 2021

Enrollment Period

2 months

First QC Date

September 11, 2020

Last Update Submit

April 5, 2021

Conditions

Blood Pressure

Keywords

Blood PressureAmbulatory blood pressure monitoringSmartwatch

Outcome Measures

Primary Outcomes (1)

  • Mean nighttime blood pressure

    Correlation of mean nighttime BP between the ABPM and the BP using the smartwatch

    Baseline

Secondary Outcomes (5)

  • Every time point blood pressure

    Baseline

  • Mean 24-hour blood pressure

    Baseline

  • Mean daytime blood pressure

    Baseline

  • Nighttime dipping

    Baseline

  • Morning blood pressure

    Baseline

Study Arms (1)

Healthy subjects

Healthy subjects without blood pressure difference on both arm

Device: Ambulatory blood pressure monitoringDevice: Galaxy Watch Active2

Interventions

Ambulatory blood pressure monitoringDEVICE

Every 30 minutes from 7 AM to 10 PM and every 1 hour from 10 PM to 7 AM

Healthy subjects
Galaxy Watch Active2DEVICE

Every 1 hour by subject (on-demand) from 7 AM to 10 PM and every 5 minutes (automatic) from 10 PM to 7 AM

Healthy subjects

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy subjects willing to participate in this trial

You may qualify if:

  • Ambulatory healthy subjects
  • Subjects aged 20 years or more

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wonju Severance Christian Hospital

Wŏnju, Gangwon-do, 26426, South Korea

Location

MeSH Terms

Interventions

Blood Pressure Monitoring, Ambulatory

Intervention Hierarchy (Ancestors)

Blood Pressure DeterminationDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisMonitoring, AmbulatoryMonitoring, Physiologic

Study Officials

  • Young Jin Youn, MD, PhD

    Wonju Severance Christian Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Division of Cardiology, Department of Internal Medicine

Study Record Dates

First Submitted

September 11, 2020

First Posted

September 18, 2020

Study Start

November 1, 2020

Primary Completion

December 31, 2020

Study Completion

March 1, 2021

Last Updated

April 8, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)