Status:
COMPLETED
EmbracePlus, Care App and Aura Usability Study
Lead Sponsor:
Empatica, Inc.
Collaborating Sponsors:
United States Department of Defense
Conditions:
Usability
Eligibility:
All Genders
18+ years
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 earl...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 31 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 31 2022
Estimated Enrollment :
335 Patients enrolled
Trial Details
Trial ID
NCT04807608
Start Date
May 31 2021
End Date
May 31 2022
Last Update
June 2 2022
Active Locations (1)
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1
Empatica Inc
Boston, Massachusetts, United States, 02108