International Validation of Wearable Sensor to Monitor COVID-19 Like Signs and Symptoms

Wearable Sensor to Monitor and Track COVID-19-like Signs and Symptoms to Develop Better Care Strategies for COVID-19 Pandemic - An Exploratory Study

1. Deploy wearable COVID sensor to collect high resolution physiological data (temperature, cardiac, respiratory and physical activity) from COVID positive patients.
2. Use collected data to train algorithm for assessing the risk of individuals presenting with symptoms suggestive of COVID-19.

Study Overview

• Status: Active, not recruiting
• Conditions: COVID-19
• Intervention / Treatment: Device: ANNE Sensor

• Study Type: Observational
• Enrollment (Anticipated): 550

Contacts and Locations

Study Locations

• India
  • Maharashtra
    • Pune, Maharashtra, India, 411057
      • Lifepoint Multi-Specialty Hospital
  • Maharastra
    • Mumbai, Maharastra, India, 400001
      • St. Georges Hospital
  • Telangana
    • Hyderabad, Telangana, India, 500035
      • Induss Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Individuals who may have experienced COVID-19 like symptoms.

Description

Inclusion Criteria:

• 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 experiencing 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.

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
COVID-19; Individuals experiencing COVID-19 like symptoms.	Device: ANNE 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.
Healthy Controls; Individuals without any known significant health problems	Device: ANNE 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart Rate	Instantaneous heart rate associated with various activity levels	Baseline; Possible reassessment up to five days after consent
Respiratory frequency	Participants will be asked to breathe normally before and after walking for 30 seconds.	Baseline; Possible reassessment up to five days after consent
Cough Frequency	Cough signal characteristics during five consecutive coughs	Baseline; Possible reassessment up to five days after consent
Body temperature	Periodic temperature readings throughout the activity sequence	Baseline; Possible reassessment up to five days after consent

Collaborators and Investigators

• Sponsor: Arun Jayaraman, PT, PhD
• Collaborators: Northwestern University; United States - India Science and Technology Endowment Fund; Induss Hospitals; Bionic Yantra; Clinfinite Solutions; Indian Institute of Technology Kharagpur

Study record dates

Study Major Dates

• Study Start (Actual): June 24, 2021
• Primary Completion (Anticipated): March 8, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: April 15, 2022
• First Submitted That Met QC Criteria: April 15, 2022
• First Posted (Actual): April 19, 2022

Study Record Updates

• Last Update Posted (Actual): January 19, 2023
• Last Update Submitted That Met QC Criteria: January 18, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: COVID-19; Wearable sensor; Machine learning
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: BY/001/2021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No