Vital Sensor Monitors for CV19 Detection

May 4, 2023 updated by: Shuai (Steve) Xu, Northwestern University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

324

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Healthy adults and adults exposed to or diagnosed with COVID19

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Healthy Adults
Adults 18 years or older
Device: ANNE One
Wireless vital sign monitoring device
COVID19
Adults 18 years or older diagnosed with COVID 19
Device: ANNE One
Wireless vital sign monitoring device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Time Frame: 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Collaborators

United States Department of Defense

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 5, 2020

Primary Completion (Actual)

March 31, 2021

Study Completion (Actual)

August 31, 2021

Study Registration Dates

First Submitted

November 13, 2020

First Submitted That Met QC Criteria

November 18, 2020

First Posted (Actual)

November 19, 2020

Study Record Updates

Last Update Posted (Estimate)

May 5, 2023

Last Update Submitted That Met QC Criteria

May 4, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU00213040

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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