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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Users | Each subject will be provided with a wearable device (smartwatch EmbracePlus manufactured by Empatica), to be worn every day outside of work hours for a total of 6 weeks. After the 6 weeks of data collection the participant will be asked to fill an online questionnaire related to the system usability (max 20 min). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Usability Assessment | Other | A survey will be administered to the subject at the end of the 6th week of product usage related to the wearable device and the related software platform's usability. Survey items will include both Likert-scale items that will be analyzed quantitatively and open-ended feedback that will be summarized qualitatively. |
| Measure | Description | Time Frame |
|---|---|---|
| EmbracePlus, Care App and Aura Usability: Based on user survey | Determine the ease of use of the system composed of EmbracePlus, Care app and Aura algorithm and user satisfaction, by means of a survey items that include both Likert-scale items that will be analyzed quantitatively and open-ended feedback that will be summarized qualitatively. | After 6 weeks of system usage |
| EmbracePlus, Care App and Aura safety: total number (%) of AEs and SAEs | The second primary endpoint will be the total number (%) of AEs and SAEs related to the device use | After 6 weeks of system usage |
| Measure | Description | Time Frame |
|---|---|---|
| EmbracePlus, Care app and Aura reliability with different smartphones | Evaluate the reliability of the system with different brands and models of smartphone by means of participants reported bugs and problems | Single-point evaluation (baseline) |
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Inclusion Criteria:
Exclusion Criteria:
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Healthy men and women over 18, based in the US, without pre-existing pathologies that can affect their physiological parameters.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Empatica Inc | Boston | Massachusetts | 02108 | United States |
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