Wearable Sensor to Monitor COVID-19 Like Signs and Symptoms

NCT04393558 | Completed

• 1 other identifier: STU00212522
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.Develop a wearable sensor package to gather data on COVID-19-like signs and symptoms such as elevated body temperature, respiratory parameters, heart rate ,cough and gait.
2. 2.Create algorithms to monitor and track changes to COVID19-like signs and symptoms for developing a better care and isolation strategies for COVID-19 pandemic.

Conditions

COVID-19; Healthy Control

Keywords

Wearable sensor; COVID-19; Machine learning

Outcome Measures

Primary Outcomes (4)

• Body temperature

  Body temperature : Periodic temperature readings over the day (every 15 minutes)

  Minimum 7 days from day 1 of study enrollment up to 60 days

• Cough Frequency

  Number of coughing episodes in an hour

  Minimum 7 days from day 1 of study enrollment up to 60 days

• Respiratory frequency

  Number of breaths per minute

  Minimum 7 days from day 1 of study enrollment up to 60 days

• Heart Rate Instantaneous heart rate every 15 minutes.

  Instantaneous heart rate every 15 minutes

  Minimum 7 days from day 1 of study enrollment up to 60 days

Study Arms (2)

COVID-19

Individuals experiencing COVID-19 like symptoms.

Device: ADAM Sensor

Healthy Controls

Individuals without any known significant health problems

Device: ADAM Sensor

Interventions

ADAM Sensor DEVICE

ADAM sensor The data collected from this sensor contains a wide range of core and novel respiratory digital biomarkers as a home-based early identification system. The core measurements include: heart rate, heart rate variability, temperature, physical activity (including sleep quality) and respiratory rate. The novel respiratory digital biomarkers include: respiratory cadence (expiration / inspiration time), coughing, swallowing, throat clearing, and talk time.

COVID-19; Healthy Controls

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Individuals who may have experienced COVID-19 like symptoms.

You may qualify if:

• Ages between 18-95 years old
• Currently experiencing any COVID-like signs and symptoms such as fever, cough, shortness of breath, trouble breathing, persistent pain or pressure in the chest, confusion or inability to arouse, bluish lips or face.
• Individuals who are not experience any COVID like signs and symptoms (will be asked to be healthy control)
• Able and willing to give written consent and comply with study procedures.

You may not qualify if:

• Inability to understand instructions and follow a three step command.
• The subject is pregnant, nursing or planning a pregnancy.
• Inability to provide written consent.

Sponsors & Collaborators

• Shirley Ryan AbilityLab: lead

Study Sites (1)

Shirley Ryan AbilityLab

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Arun Jayaraman, PhD

  Shirley Ryan AbilityLab

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Max Nader Laboratory

Study Record Dates

• First Submitted: May 16, 2020
• First Posted: May 19, 2020
• Study Start: April 20, 2020
• Primary Completion: October 26, 2020
• Study Completion: October 26, 2020
• Last Updated: April 17, 2025

Record last verified: 2025-04

Locations

US (1)