Fever Tracking Study

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Fever Tracking Study: The Feasibility of Fever Tracking in a Home-setting by a Non-invasive Wearable Core Body Temperature Sensor

Conditions
-----------------
Core Body Temperature in Healthy Subjects, Immune Response to mRNA COVID-19 Vaccination

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-60 years old Informed consent signed Either: 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 Exclusion Criteria: 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: Wounds Active venous access Amputations Dialysis shunt Edema Axillary dissection Continuous long-term monitoring of blood pressure Tattoos Known allergy to plastics / latex Language problems

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | This comparison will be done for each position of the wearable CBT sensor (apical, upper arm and wrist). | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean absolute error, mean bias and standard deviation of the predicted CBT sensor compared to the reference temperature method (ingestible electronic pill). | In addition to the primary outcome measure, the heartrate will be used as additional input to perform the CBT prediction of the wearables. | 48 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fever Tracking, Core body temperature CBT, mRNA COVID-19 vaccination, Wearable sensors, Wearables