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EmbracePlus, Care App and Aura Usability Study

Usability Clinical Trial

Official title:
Study for the Evaluation of the Usability of EmbracePlus, Empatica Care Platform and Aura Algorithm

Clinical Trial Summary

The purpose of this study is to evaluate the usability of the system which includes the wearable device, app and cloud data processing, including an algorithm (Aura) capable of detecting possible early signs of respiratory infections in healthy individuals. In addition, the investigators would like to evaluate the presence of any allergic reactions to materials used in the manufacture of the EmbracePlus.

Clinical Trial Description

The investigators wish to evaluate of the usability, according to the requirements of IEC 62366-1:2015/AMD 1:2020 of a wearable device - EmbracePlus, the Empatica Care app and Aura algorithm, an early-warning wearable/AI platform for alerting to COVID-19 and other possible respiratory infections before a person is symptomatic. The system consists is a smartwatch coupled with an AI algorithm (Aura) developed by Empatica. The Aura algorithm analyzes physiological signals and derived biomarkers (such as sleep patterns) in order to detect possible early signs of respiratory infection. It has been originally developed by Empatica, validated with influenza and rhinovirus data and is being currently validated for COVID-19 infections. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04807608
Study type Observational
Source Empatica, Inc.
Contact
Status Completed
Phase
Start date May 31, 2021
Completion date May 31, 2022
View Details
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