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OpenTrials
Completed

NCT Number: NCT04553861

Smartwatch ABPM vs. Conventional ABPM

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

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Key information

Conditions

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Wonju Severance Christian Hospital

Wŏnju, Gangwon-do, 26426, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ambulatory blood pressure monitoring

Device

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

Galaxy Watch Active2

Device

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

Primary outcomes

  1. Mean nighttime blood pressure

    Time frame: Baseline

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

Secondary outcomes

  1. Every time point blood pressure

    Time frame: Baseline

    BP differences between the ABPM and the BP using the smartwatch at every time point of measurement

  2. Mean 24-hour blood pressure

    Time frame: Baseline

    Correlation of mean 24-h BP between the ABPM and the BP using the smartwatch

  3. Mean daytime blood pressure

    Time frame: Baseline

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

  4. Nighttime dipping

    Time frame: Baseline

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

  5. Morning blood pressure

    Time frame: Baseline

    Correlation of morning BP between the ABPM and the BP using the smartwatch

Sponsors and collaborators

Lead sponsor

Wonju Severance Christian Hospital

Other

Collaborators

  • Samsung Electronics

Registry information

Official study title

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

Acronym: SamsungWatch

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Sep 18, 2020
Registry last updated
Apr 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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