Fever Tracking Study: The Feasibility of Fever Tracking in a Home-setting by a Non-invasive Wearable Core Body Temperature Sensor
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Mean absolute error, bias and standard deviation of the predicted CBT by the wearable CBT sensor compared to the reference temperature method (ingestible electronic pill)
研究概览
简要总结
The aim of this study is to investigate the feasibility of continuous fever tracking of participants having fever symptoms in a home setting, using a core body temperature (CBT) sensor. CBT as measured by the wearable sensors will be coampared with CBT as measured by ingestible electronc pills (reference).
A secondary research question is, if the CBT behavior of the the participants in a home setting can be compared to previously described CBT profiles in the literature, and if special patterns can be identified.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-60 years old
- •Informed consent signed
- •Acute fever symptoms at inclusion (at least 38.0°C) and Test for COVID-19 at the day of inclusion
- •Or: Second shot or booster of mRNA COVD-19 vaccination (Comirnaty® or COVID-19 Vaccine Moderna®) at day of inclusion
排除标准
- •Any participant who, for any reason, is unable to independently consent to participate in the study and/or who is unable to independently follow the study protocol.
- •Any participant with previous surgical procedures in the gastrointestinal tract
- •Inability to swallow pills
- •Any participant of ≤40 kg body weight
- •A scheduled MRI examination in the period from the start of the measurements until seven days after ingestion of the electronic pill.
- •Any participant being pregnant
- •Impairment or disability of the upper extremity likely to have a negative impact on the quality of measurements:
- •Active venous access
- •Amputations
- •Dialysis shunt
- •Axillary dissection
- •Continuous long-term monitoring of blood pressure
- •Known allergy to plastics / latex
- •Language problems
结局指标
主要结局
Mean absolute error, bias and standard deviation of the predicted CBT by the wearable CBT sensor compared to the reference temperature method (ingestible electronic pill)
时间窗: 48 hours
This comparison will be done for each position of the wearable CBT sensor (apical, upper arm and wrist).
次要结局
- Mean absolute error, mean bias and standard deviation of the predicted CBT sensor compared to the reference temperature method (ingestible electronic pill).(48 hours)