Study for the Evaluation of the Usability of EmbracePlus, Empatica Care Platform and Aura Algorithm
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 335
- 试验地点
- 1
- 主要终点
- EmbracePlus, Care App and Aura Usability: Based on user survey
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
EmbracePlus, Care App and Aura Usability: Based on user survey
时间窗: 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
时间窗: After 6 weeks of system usage
The second primary endpoint will be the total number (%) of AEs and SAEs related to the device use
次要结局
- EmbracePlus, Care app and Aura reliability with different smartphones(Single-point evaluation (baseline))