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Clinical Trials/NCT04635787
NCT04635787
Completed
N/A

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

Northwestern University1 site in 1 country324 target enrollmentNovember 5, 2020
ConditionsCovid19

Overview

Phase
N/A
Intervention
Not specified
Conditions
Covid19
Sponsor
Northwestern University
Enrollment
324
Locations
1
Primary Endpoint
1.Efficacy of wearable device to detect respiratory infection parameters: cough count
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

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

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
November 5, 2020
End Date
August 31, 2021
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Shuai (Steve) Xu

Principal Investigator

Northwestern University

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

  • 2.Monitoring of respiratory infection symptoms, WURSS-11 Survey(Time Frame: 1 year)

Study Sites (1)

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