UsabilityNCT04807608
EmbracePlus, Care App and Aura Usability Study
An observational study of Usability, run by Empatica, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Usability
- What is being tested?
- Usability Assessment
- How many people
- 335 participants
- Where
- 1 siteUnited States
- Study dates
- 31 May 2021to 31 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy men and women over 18, based in the US, without pre-existing pathologies that can affect their physiological parameters.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study for the Evaluation of the Usability of EmbracePlus, Empatica Care Platform and Aura Algorithm
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.
Read the 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.
- Conditions
- Usability
- Being tested
- Usability Assessment
- Keywords
- Usability, Wearable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usability AssessmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Users | 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). Receives: Other: Usability Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
EmbracePlus, Care App and Aura Usability: Based on user survey
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.
Measured: After 6 weeks of system usage
EmbracePlus, Care App and Aura safety: total number (%) of AEs and SAEs
The second primary endpoint will be the total number (%) of AEs and SAEs related to the device use
Measured: After 6 weeks of system usage
Secondary outcomes (1)
EmbracePlus, Care app and Aura reliability with different smartphones
Evaluate the reliability of the system with different brands and models of smartphone by means of participants reported bugs and problems
Measured: Single-point evaluation (baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2021
- Study start31 May 2021
- Primary completion31 May 2022
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UsabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 335 participants (actual)
Sponsor and investigators
- Lead sponsor
- Empatica, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04807608
- Sponsor's protocol ID
- 2021-001
- Status last verified
- Jun 2022
- First submitted
- 17 Mar 2021
- Last updated
- 2 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study for the Evaluation of the Usability of EmbracePlus, Empatica Care Platform and Aura Algorithm
- ClinicalTrials.gov ID
- NCT04807608
- Acronym / sponsor ID
- 2021-001
- Conditions
- Usability
- Keywords
- Usability, Wearable
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 335 participants (actual)
- Lead sponsor
- Empatica, Inc.Industry (pharma, biotech, devices)
- Collaborators
- United States Department of Defense
- Study start
- 31 May 2021 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 19 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Users | – | Other: Usability AssessmentEach 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy men and women over 18, based in the US, without pre-existing pathologies that can affect their physiological parameters.
Key inclusion criteria (8 listed)
- 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).
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Usability AssessmentA 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. | Other | Healthy Users |
Primary outcome
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.
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
1 secondary outcome
EmbracePlus, Care app and Aura reliability with different smartphones
Time frame: Single-point evaluation (baseline)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Usability, run by Empatica, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EmbracePlus, Care App and Aura Usability: Based on user survey (time frame: After 6 weeks of system usage). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2022.