Clincosm LogoSign in Get a demo

Vital Sensor Monitors for CV19 Detection

Sponsor
Northwestern University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04635787
Collaborator
United States Department of Defense (U.S. Fed)
324
Enrollment
1
Location
23.8
Anticipated Duration (Months)
13.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: ANNE One

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 Design

Study Type:
Observational
Actual Enrollment :
324 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official 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
Actual Study Start Date :
Nov 5, 2020
Actual Primary Completion Date :
Mar 31, 2021
Anticipated Study Completion Date :
Oct 30, 2022

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

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

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Northwestern Memorial Hospital Chicago Illinois United States 60611

Sponsors and Collaborators

  • Northwestern University
  • United States Department of Defense

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Shuai (Steve) Xu, Principal Investigator, Northwestern University
ClinicalTrials.gov Identifier:
NCT04635787
Other Study ID Numbers:
  • STU00213040
First Posted:
Nov 19, 2020
Last Update Posted:
Jan 11, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
COVID-19

Study Results

No Results Posted as of Jan 11, 2022