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

Sponsor

Arun Jayaraman, PT, PhD (Other)

Overall Status

Recruiting

CT.gov ID

NCT05334680

Collaborator

United States - India Science and Technology Endowment Fund (Other), Northwestern University (Other), Induss Hospitals (Other), Bionic Yantra (Other), Clinfinite Solutions (Other), Indian Institute of Technology Kharagpur (Other)

550

Enrollment

Locations

30.2

Anticipated Duration (Months)

183.3

Patients Per Site

6.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
COVID-19	Device: ANNE Sensor

Study Design

Study Type:

Observational

Anticipated Enrollment :

550 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jun 24, 2021

Anticipated Primary Completion Date :

Mar 8, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	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.

Arm

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 95 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Lifepoint Multi-Specialty Hospital	Pune	Maharashtra	India	411057
2	St. Georges Hospital	Mumbai	Maharastra	India	400001
3	Induss Hospitals	Hyderabad	Telangana	India	500035

Sponsors and Collaborators

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

Investigators

Principal Investigator: Arun Jayaraman, PT, PhD, Shirley Ryan AbilityLab

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Arun Jayaraman, PT, PhD, Director Max Nader Laboratory, Shirley Ryan AbilityLab

ClinicalTrials.gov Identifier:

NCT05334680

Other Study ID Numbers:

BY/001/2021

First Posted:

Apr 19, 2022

Last Update Posted:

Apr 25, 2022

Last Verified:

Apr 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Arun Jayaraman, PT, PhD, Director Max Nader Laboratory, Shirley Ryan AbilityLab

Wearable sensor

Machine learning

COVID-19

Additional relevant MeSH terms:

COVID-19

Study Results

No Results Posted as of Apr 25, 2022