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

Arun Jayaraman, PT, PhD550 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

550

Conditions

COVID-19

Interventions

ANNE SensorDEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 95 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (3)

St. Georges Hospital

Mumbai, Maharashtra, India

Lifepoint Multi-Specialty Hospital

Pune, Maharashtra, India

Induss Hospitals

Hyderabad, Telangana, India

Outcomes

Primary Outcomes

Heart Rate

Instantaneous heart rate associated with various activity levels

Time frame: 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.

Time frame: Baseline; Possible reassessment up to five days after consent

Cough Frequency

Cough signal characteristics during five consecutive coughs

Time frame: Baseline; Possible reassessment up to five days after consent

Body temperature

Periodic temperature readings throughout the activity sequence

Time frame: Baseline; Possible reassessment up to five days after consent

Data from ClinicalTrials.gov

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