EmbracePlus, Care App and Aura Usability Study
Completed
Conditions studied: Usability
In brief
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.
Key facts
- Study ID
- NCT04807608
- Run by
- Empatica, Inc.
- People needed
- 335
- Starts
- 2021-05-31
- Expected to finish
- 2022-05-31
- Last updated by the study team
- 2022-06-02
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
Where it is running
- Empatica Inc — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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