Fever Tracking Study

University Hospital, Basel, Switzerland61 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Universitiy Hospital Basel

Basel, Canton of Basel-City, Switzerland

Outcomes

Primary Outcomes

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).

Time frame: 48 hours

Secondary Outcomes

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.

Time frame: 48 hours

Data from ClinicalTrials.gov

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