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

NCT05334680 | Unknown

• 1 other identifier: BY/001/2021
• Study Type: observational
• Target: 550
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

COVID-19

Keywords

Wearable sensor; Machine learning; COVID-19

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

COVID-19

Individuals experiencing COVID-19 like symptoms.

Device: ANNE Sensor

Healthy Controls

Individuals without any known significant health problems

Device: ANNE Sensor

Interventions

ANNE Sensor DEVICE

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
• Healthy Volunteers: Yes
• 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 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.

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

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

Study Sites (3)

St. Georges Hospital

Mumbai, Maharashtra, 400001, India

Location

Lifepoint Multi-Specialty Hospital

Pune, Maharashtra, 411057, India

Location

Induss Hospitals

Hyderabad, Telangana, 500035, India

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, PT, PhD

  Shirley Ryan AbilityLab

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 15, 2022
• First Posted: April 19, 2022
• Study Start: June 24, 2021
• Primary Completion: March 8, 2023
• Study Completion: December 31, 2023
• Last Updated: January 19, 2023

Record last verified: 2023-01

Locations

IN (3)