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临床试验/NCT04393558
NCT04393558已完成不适用

Wearable Sensor to Monitor COVID-19 Like Signs and Symptoms

Shirley Ryan AbilityLab1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2020年4月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
75
试验地点
1
主要终点
Cough Frequency

研究概览

简要总结

  1. Develop a wearable sensor package to gather data on COVID-19-like signs and symptoms such as elevated body temperature, respiratory parameters, heart rate ,cough and gait.
  2. Create algorithms to monitor and track changes to COVID19-like signs and symptoms for developing a better care and isolation strategies for COVID-19 pandemic.

详细描述

Aim 1:

Each enrolled participant will be asked to wear the sensor on a daily basis. Duration of the participation varies based on the symptom severity. With the currently available information, recovery times are ranging from 7 days to 56 days. The duration of the study participation can begin at the early detection to all the way until complete recovery or discharge. Participants may be asked to use the sensors anywhere from 7 days to 60 days. Duration of study will be based on the participant's self-reported symptoms or as appropriate determined by the PI. This will allow the research team to collect a comprehensive data set that can characterize both COVID-like and non-COVID-like signs and symptoms.

Aim 2:

Data collected from Aim#1 will aid in generating machine learning algorithms to characterize the signs and symptoms. Further algorithm development will be carried out to develop signs and symptoms progression and regression models for early warning or warning to prevent return to work of health-care staff or civilians

Wearable sensors are compact battery powered miniature electronic devices that are attached to a user's body to record physiological, biochemical and physical activity information. Different types of sensors can be used to monitor these digital biomarkers. Inertial measurement units (IMUs), including accelerometers, gyroscopes, magnetometers are typically used to measure physical activity, movement signatures. Miniature temperature, galvanic skin response (GSR), photoplethysmogram (PPG), oxygen saturation (SPO2) sensors are increasingly embedded in wearable devices for vital sign monitoring. Non-invasive monitoring is very ideal in the current pandemic situation. These sensors can be potentially deployed in large scale to monitor cases of suspected infection and patients recovering from COVID-19.

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 95 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Ages between 18-95 years old
  • Currently experiencing any COVID-like signs and symptoms such as fever, cough, shortness of breath, trouble breathing, persistent pain or pressure in the chest, confusion or inability to arouse, bluish lips or face.
  • Individuals who are not experience any COVID like signs and symptoms (will be asked to be healthy control)
  • Able and willing to give written consent and comply with study procedures.

排除标准

  • Inability to understand instructions and follow a three step command.
  • The subject is pregnant, nursing or planning a pregnancy.
  • Inability to provide written consent.

结局指标

主要结局

Cough Frequency

时间窗: Minimum 7 days from day 1 of study enrollment up to 60 days

Number of coughing episodes in an hour

Body temperature

时间窗: Minimum 7 days from day 1 of study enrollment up to 60 days

Body temperature : Periodic temperature readings over the day (every 15 minutes)

Respiratory frequency

时间窗: Minimum 7 days from day 1 of study enrollment up to 60 days

Number of breaths per minute

Heart Rate Instantaneous heart rate every 15 minutes.

时间窗: Minimum 7 days from day 1 of study enrollment up to 60 days

Instantaneous heart rate every 15 minutes

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Arun Jayaraman, PT, PhD

Director Max Nader Laboratory

Shirley Ryan AbilityLab

研究点 (1)

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