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

Study Overview
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Brief Summary
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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.

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

Conditions
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COVID-19

Intervention / Treatment
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* Device: ANNE Sensor


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| COVID-19<br>Individuals experiencing COVID-19 like symptoms. | Device: ANNE Sensor<br>* 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.<br>|
| Healthy Controls<br>Individuals without any known significant health problems | Device: ANNE Sensor<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Wearable sensor, Machine learning, COVID-19