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Completed

NCT Number: NCT04807608

EmbracePlus, Care App and Aura Usability Study

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.

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Key information

Conditions

Usability

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Empatica Inc

Boston, Massachusetts, 02108, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age: Participants must be between the ages of 18-99
  • Gender: No restrictions
  • Disease: healthy participants
  • Adult participant must either be able to give consent
  • Participants must be fluent in the language of the consent forms (Currently limited to English).
  • Participants must reside in the United States.
  • Participants should have a physical home address where they can receive the device
  • Participants must have a personal smartphone Apple or Android (at least iPhone 8 or Android 5.0)

Exclusion criteria

  • 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.
  • Participants are not willing to wear the device during nighttime
  • Participants should not have pre-existing cardiovascular disease or respiratory disease
  • Participants must not be pregnant or planning to become pregnant within two months at the time of screening

Treatment and study plan

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.

Primary outcomes

  1. EmbracePlus, Care App and Aura Usability: Based on user survey

    Time frame: After 6 weeks of system usage

    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.

  2. EmbracePlus, Care App and Aura safety: total number (%) of AEs and SAEs

    Time frame: After 6 weeks of system usage

    The second primary endpoint will be the total number (%) of AEs and SAEs related to the device use

Secondary outcomes

  1. EmbracePlus, Care app and Aura reliability with different smartphones

    Time frame: Single-point evaluation (baseline)

    Evaluate the reliability of the system with different brands and models of smartphone by means of participants reported bugs and problems

Sponsors and collaborators

Lead sponsor

Empatica, Inc.

Industry

Collaborators

  • United States Department of Defense

Registry information

Official study title

Study for the Evaluation of the Usability of EmbracePlus, Empatica Care Platform and Aura Algorithm

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 19, 2021
Registry last updated
Jun 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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