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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

550 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-24

Study Completion Date

2023-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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COVID-19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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COVID-19

Individuals experiencing COVID-19 like symptoms.

ANNE Sensor

Intervention Type DEVICE

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

ANNE Sensor

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes