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临床试验/NCT05117762
NCT05117762Unknown不适用

A Validation Study Comparing the Heart Rate, Respiratory Rate, Heart Rate Variability and Blood Pressure Obtained by Video Selfie Using DocMe® Technology With Those Obtained by Direct Measurement in Adults

DocMe Technologies Ltd1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2021年11月2日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
300
试验地点
1
主要终点
Respiratory Rate

研究概览

简要总结

The aim of this study is to compare accuracy of DocMe, a video technology developed by DocMe Health Technologies, with previously validated medical devices used for measurements of heart rate, heart rate variability, respiratory rate and blood pressure in adults.

详细描述

Photoplethysmography (PPG) makes uses of low-intensity infrared (IR) light. When light travels through biological tissues, it is absorbed by bones, skin pigments and both venous and arterial blood. However, as light is more strongly absorbed by blood than the surrounding tissues, the changes in blood flow can be detected by PPG sensors as changes in the intensity of light.

The signal from PPG is proportional to the quantity of blood flowing through the blood vessels and even small changes in blood volume can be detected using this method. Analysis of the waveform can provide information on a range of physiological measurements affecting the cardiovascular and respiratory systems. PPG is widely used in medicine in the form of pulse oximeters using sensors applied to peripheral digits.

Recently, it has been shown that PPG data can be obtained using images acquired from videos taken using the camera on smartphones and there is now a significant and growing body of published literature to support this.

DocMe Health Technologies has developed a system of obtaining these data using a video selfie.

At this time, the technology has been shown to be reasonably accurate when compared to home devices in healthy subjects. However, to make the technology more widely useful, the results obtained by video selfies need to be formally validated.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults (18 - 100 years old). Participants must be willing and able to give informed consent for participation in the study, and considered fit for the study by the nurse.

排除标准

  • 未提供

结局指标

主要结局

Respiratory Rate

时间窗: Baseline

Respiratory Rate in breaths/min assessed visually or oximeter if it has the capability assessed 3 times at 10 minute intervals on one occasion

Heart Rate

时间窗: Baseline

Heart Rate (beats/minute) assessed 3 times at 10 minute intervals on one occasion

Blood Pressure

时间窗: Baseline

Systolic and Diastolic Blood Pressure assessed 3 times at 10 minute intervals on one occasion

Heart Rate Variability

时间窗: Baseline

Heart Rate (beats/minute) assessed 3 times at 10 minute intervals on one occasion

次要结局

未报告次要终点

研究者

发起方
DocMe Technologies Ltd
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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