Smartwatch ABPM vs. Conventional ABPM | NCT04553861

Studies
Smartwatch ABPM vs. Conventional ABPM

NCT04553861

Sponsor

Wonju Severance Christian Hospital

Status

Completed

Last Update Posted

Apr 8, 2021Actual

Enrollment

30Actual

Phase

Not provided

Conditions

Blood Pressure

Interventions

Ambulatory blood pressure monitoring
Galaxy Watch Active2

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2020Actual

Primary Completion Date

Dec 31, 2020Actual

Completion Date

Mar 1, 2021Actual

First Submitted Date

Sep 11, 2020

First Submission Date that Met QC Criteria

Sep 11, 2020

First Posted Date

Sep 18, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 5, 2021

Last Update Posted Date

Apr 8, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Young Jin Youn, Assistant Professor, Division of Cardiology, Department of Internal Medicine, Wonju Severance Christian HospitalPrincipal Investigator

Lead Sponsor

Wonju Severance Christian HospitalOTHER

Collaborators

Name	Class
Samsung Electronics	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

2 Days

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Healthy subjects		Healthy subjects without blood pressure difference on both arm	Device: Ambulatory blood pressure monitoring Device: Galaxy Watch Active2

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ambulatory blood pressure monitoring	Device	Every 30 minutes from 7 AM to 10 PM and every 1 hour from 10 PM to 7 AM	Healthy subjects

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Healthy subjects willing to participate in this trial

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Young Jin Youn, MD, PhD	Wonju Severance Christian Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Wonju Severance Christian Hospital		Wŏnju	Gangwon-do	26426	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D018660	Blood Pressure Monitoring, Ambulatory

Ancestor Terms

ID	Term
D001795	Blood Pressure Determination
D003935	Diagnostic Techniques, Cardiovascular
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

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Browse Branches

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