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Completed

NCT Number: NCT04635787

Vital Sensor Monitors for CV19 Detection

This study will monitor physical bio-markers such as heart rate, respiratory rate, and temperature to detect potential COVID-19 infections.

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

About this study

The purpose of this research is to assess the accuracy of wearable sensors at detecting and monitoring COVID-19 infections. Our small, wearable sensor can get data on your respiration, body temperature, heart rate, and blood oxygen level, which may help physicians better identify if a respiratory condition is worsening overtime. If successful, our sensor could help healthcare professionals detect early symptoms of COVID-19 respiratory infection and monitor recovery and treat people before their condition worsens significantly.

Who can participate

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

Inclusion criteria

  • Adults aged 18 years old or over
  • Recent (within 1 week) occupational or home exposure to a newly diagnosed COVID-19 infected individual
  • Able and willing to give written consent and comply with study procedures

Exclusion criteria

  • Inability to understand instructions and follow a three step command
  • The subject is pregnant, nursing or planning a pregnancy
  • Inability to provide written consent
  • Past confirmed COVID-19 infection with resolution of symptoms
  • Past confirmed COVID-19 active infection moderate or severe symptoms

Treatment and study plan

ANNE One

Device

Wireless vital sign monitoring device

Primary outcomes

  1. 1.Efficacy of wearable device to detect respiratory infection parameters: cough count

    Time frame: 1 year

    Device data measuring cough count. Captured by analysis of peak acclerometer graphing and duration in meters per second squared (m/s2).

Secondary outcomes

  1. 2.Monitoring of respiratory infection symptoms, WURSS-11 Survey

    Time frame: Time Frame: 1 year

    WURSS-11 survey. https://www.fammed.wisc.edu/files/webfm-uploads/documents/research/wurss-11.pdf The WURSS-11 survey will be conducted on a weekly basis by study subjects for the duration of the study (up to 52 weeks).

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • United States Department of Defense

Registry information

Official study title

ICU-Grade Wearable Sensors With Novel Respiratory Biomarkers to Diagnose and Detect Pre- and Very Early Symptomatic COVID-19 Infection Using Predictive Machine Learning Algorithms

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 19, 2020
Registry last updated
May 6, 2023

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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