Core Body Temperature in Healthy Subjects, Immune Response to mRNA COVID-19 Vaccination
Conditions
Keywords
Fever Tracking, Core body temperature CBT, mRNA COVID-19 vaccination, Wearable sensors, Wearables
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.
Interventions
None listed
Sponsors
greenTEG AG
University Hospital, Basel, Switzerland
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 48 hours | This comparison will be done for each position of the wearable CBT sensor (apical, upper arm and wrist). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean absolute error, mean bias and standard deviation of the predicted CBT sensor compared to the reference temperature method (ingestible electronic pill). | 48 hours | In addition to the primary outcome measure, the heartrate will be used as additional input to perform the CBT prediction of the wearables. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Influence of weight on the predicted CBT | 48 hours | Weight measured in kg |
| Influence of height on the predicten CBT | 48 hours | Height measured in cm |
| Influence of skin colour on the predicted CBT | 48 hours | Skin colour measured on the Fitzpatrick Skin Type Scala which classifies skin types from I to VI, depending on the amount of melanin pigment. Type I contains the lowest level of melanin, whereas type VI has the highest level. |
| Influence of age on the predicted CBT | 48 hours | Age measured in years |
| Influence of food intake on the predicted CBT | 48 hours | The impact of the above mentioned factor on the CBT will be monitored and recorded in a participant diary |
| Influence of concomitant medications on the predicted CBT | 48 hours | The impact of the above mentioned factors on the CBT will be monitored and recorded in a participant diary |
| Influence of hairiness on the predicted CBT | 48 hours | Degree of hairiness expressed as mild, moderate and strong |
| Influence of sex on the predicted CBT | 48 hours | — |
Countries
Switzerland
Outcome results
None listed