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

Active, not recruiting

• Conditions: COVID-19

• Registration Number: NCT05334680
• Lead Sponsor: Arun Jayaraman, PT, PhD

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-24
• Study First Submitted: 2022-04-15
• Study First Submitted QC: 2022-04-15
• Study First Posted: 2022-04-19
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-18
• Last Update Posted: 2023-01-19
• Primary Completion: 2023-03-08
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 550

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.
Body temperature	Baseline; Possible reassessment up to five days after consent	Periodic temperature readings throughout the activity sequence
Cough Frequency	Baseline; Possible reassessment up to five days after consent	Cough signal characteristics during five consecutive coughs

Trial Locations

Locations (3)

Lifepoint Multi-Specialty Hospital; 🇮🇳 Pune, Maharashtra, India

St. Georges Hospital; 🇮🇳 Mumbai, Maharastra, India

Induss Hospitals; 🇮🇳 Hyderabad, Telangana, India