Trials / Completed
CompletedNCT04807608
EmbracePlus, Care App and Aura Usability Study
Study for the Evaluation of the Usability of EmbracePlus, Empatica Care Platform and Aura Algorithm
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 335 (actual)
- Sponsor
- Empatica, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
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.
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Usability Assessment | 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. |
Timeline
- Start date
- 2021-05-31
- Primary completion
- 2022-05-31
- Completion
- 2022-05-31
- First posted
- 2021-03-19
- Last updated
- 2022-06-02
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT04807608. Inclusion in this directory is not an endorsement.