Vital Sensor Monitors for CV19 Detection

Completed

• Conditions: Covid19
• Interventions: Device: ANNE One

• Registration Number: NCT04635787
• Lead Sponsor: Northwestern University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2020-11-05
• Study First Submitted: 2020-11-13
• Study First Submitted QC: 2020-11-18
• Study First Posted: 2020-11-19
• Primary Completion: 2021-03-31
• Study Completion: 2021-08-31
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-04
• Last Update Posted: 2023-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 324

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy Adults	ANNE One	Adults 18 years or older
COVID19	ANNE One	Adults 18 years or older diagnosed with COVID 19

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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).

Trial Locations

Locations (1)

Northwestern Memorial Hospital; 🇺🇸 Chicago, Illinois, United States