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临床试验/NCT04553861
NCT04553861
已完成
不适用

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

Wonju Severance Christian Hospital1 个研究点 分布在 1 个国家目标入组 30 人2020年11月1日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Blood Pressure
发起方
Wonju Severance Christian Hospital
入组人数
30
试验地点
1
主要终点
Mean nighttime blood pressure
状态
已完成
最后更新
5年前

概览

简要总结

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

详细描述

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.

注册库
clinicaltrials.gov
开始日期
2020年11月1日
结束日期
2021年3月1日
最后更新
5年前
研究类型
Observational
性别
All

研究者

发起方
Wonju Severance Christian Hospital
责任方
Principal Investigator
主要研究者

Young Jin Youn

Assistant Professor, Division of Cardiology, Department of Internal Medicine

Wonju Severance Christian Hospital

入排标准

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Mean nighttime blood pressure

时间窗: Baseline

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

次要结局

  • Mean daytime blood pressure(Baseline)
  • Nighttime dipping(Baseline)
  • Mean 24-hour blood pressure(Baseline)
  • Every time point blood pressure(Baseline)
  • Morning blood pressure(Baseline)

研究点 (1)

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