EmbracePlus, Care App and Aura Usability Study

Empatica

Status: Completed

Conditions: Usability

Treatments: Other: Usability Assessment

Study type: Observational

Funder types: Industry; Other U.S. Federal agency

Identifiers

NCT04807608

2021-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 335 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

335 participants in 1 patient group

Healthy Users

Description:

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).

Treatment:

Other: Usability Assessment