Vital Sensor Monitors for CV19 Detection

Covid19 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04635787
• Other study ID #: STU00213040
• Status: Completed
• Start date: November 5, 2020
• Est. completion date: August 31, 2021

Study information

• Verified date: May 2023
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 324
• Est. completion date: August 31, 2021
• Est. primary completion date: March 31, 2021
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Device:
• ANNE One
Wireless vital sign monitoring device

Locations

Country	Name	City	State
United States	Northwestern Memorial Hospital	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1.Efficacy of wearable device to detect respiratory infection parameters: cough count	Device data measuring cough count. Captured by analysis of peak acclerometer graphing and duration in meters per second squared (m/s2).	1 year
Secondary	2.Monitoring of respiratory infection symptoms, WURSS-11 Survey	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