Clinical trial NCT05475067: Fever Tracking Study
Official title: Fever Tracking Study: The Feasibility of Fever Tracking in a Home-setting by a Non-invasive Wearable Core Body Temperature Sensor
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Core Body Temperature in Healthy Subjects
Immune Response to mRNA COVID-19 Vaccination
Keywords: Fever Tracking
Core body temperature CBT
mRNA COVID-19 vaccination
Wearable sensors
Wearables
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: greenTEG AG
First posted: 2022-07-26
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects testing for COVID-19 at the University Hospital Basel and having acute fever symptoms, or individuals receiving the second shot or the booster of an mRNA COVID 19 vaccination, will be informed about the possibility to participate in this study by study personnel on-site.

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.


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

Primary outcomes:
measure: 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)
timeFrame: 48 hours
Secondary outcomes:
measure: Mean absolute error, mean bias and standard deviation of the predicted CBT sensor compared to the reference temperature method (ingestible electronic pill).
timeFrame: 48 hours
Other outcomes:
measure: Influence of age on the predicted CBT
timeFrame: 48 hours
measure: Influence of sex on the predicted CBT
timeFrame: 48 hours
measure: Influence of weight on the predicted CBT
timeFrame: 48 hours
measure: Influence of height on the predicten CBT
timeFrame: 48 hours
measure: Influence of skin colour on the predicted CBT
timeFrame: 48 hours
measure: Influence of hairiness on the predicted CBT
timeFrame: 48 hours
measure: Influence of food intake on the predicted CBT
timeFrame: 48 hours
measure: Influence of concomitant medications on the predicted CBT
timeFrame: 48 hours
Locations:
city: Basel
country: Switzerland
facility: Universitiy Hospital Basel
state: Basel-Stadt
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Jens Eckstein, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: