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 Details — Status: Completed

Administrative data

• NCT number: NCT04807608
• Other study ID #: 2021-001
• Status: Completed
• Start date: May 31, 2021
• Est. completion date: May 31, 2022

Study information

• Verified date: June 2022
• Source: Empatica, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 335
• Est. completion date: May 31, 2022
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age: Participants must be between the ages of 18-99

2. Gender: No restrictions

3. Disease: healthy participants

4. Adult participant must either be able to give consent

5. Participants must be fluent in the language of the consent forms (Currently limited to English).

6. Participants must reside in the United States.

7. Participants should have a physical home address where they can receive the device

8. Participants must have a personal smartphone Apple or Android (at least iPhone 8 or Android 5.0)

Exclusion Criteria:

1. Participants must not have broken or injured skin at the wrist where EmbracePlus is worn, and they must be able to tolerate wearing EmbracePlus snugly for long periods of time. Thus, they should not have allergies to the material composition of the EmbracePlus smartwatch, or discomfort wearing a smartwatch during the night.

2. Participants are not willing to wear the device during nighttime

3. Participants should not have pre-existing cardiovascular disease or respiratory disease

4. Participants must not be pregnant or planning to become pregnant within two months at the time of screening

Related Conditions & MeSH terms

• Usability

Intervention

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.

Locations

Country	Name	City	State
United States	Empatica Inc	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Empatica, Inc.	United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	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)