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

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05334680
• Other study ID #: BY/001/2021
• Status: Active, not recruiting
• Start date: June 24, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2023
• Source: Shirley Ryan AbilityLab
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 550
• Est. completion date: December 31, 2023
• Est. primary completion date: March 8, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Intervention

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.

Locations

Country	Name	City	State
India	Induss Hospitals	Hyderabad	Telangana
India	St. Georges Hospital	Mumbai	Maharastra
India	Lifepoint Multi-Specialty Hospital	Pune	Maharashtra

Sponsors (7)

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

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart Rate	Instantaneous heart rate associated with various activity levels	Baseline; Possible reassessment up to five days after consent
Primary	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
Primary	Cough Frequency	Cough signal characteristics during five consecutive coughs	Baseline; Possible reassessment up to five days after consent
Primary	Body temperature	Periodic temperature readings throughout the activity sequence	Baseline; Possible reassessment up to five days after consent