Clinical trial NCT04807608: EmbracePlus, Care App and Aura Usability Study
Official title: Study for the Evaluation of the Usability of EmbracePlus, Empatica Care Platform and Aura Algorithm
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Usability
Keywords: Usability
Wearable
Lead sponsor: Empatica, Inc.
Sponsor class: INDUSTRY
Collaborators: name: United States Department of Defense
First posted: 2021-03-19
Enrollment: 335
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy men and women over 18, based in the US, without pre-existing pathologies that can affect their physiological parameters.

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: EmbracePlus, Care App and Aura Usability: Based on user survey
timeFrame: After 6 weeks of system usage
measure: EmbracePlus, Care App and Aura safety: total number (%) of AEs and SAEs
timeFrame: After 6 weeks of system usage
Secondary outcomes:
measure: EmbracePlus, Care app and Aura reliability with different smartphones
timeFrame: Single-point evaluation (baseline)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Empatica Inc
state: Massachusetts
Study officials:
References: