Fever Tracking Study

Sponsor

University Hospital, Basel, Switzerland (Other)

Overall Status

Completed

CT.gov ID

NCT05475067

Collaborator

greenTEG AG (Industry)

Enrollment

Location

4.9

Actual Duration (Months)

12.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Core Body Temperature in Healthy Subjects Immune Response to mRNA COVID-19 Vaccination

Study Design

Study Type:

Observational

Actual Enrollment :

61 participants

Observational Model:

Case-Only

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Oct 7, 2021

Actual Primary Completion Date :

Mar 3, 2022

Actual Study Completion Date :

Mar 5, 2022

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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 Outcome Measures

Influence of age on the predicted CBT [48 hours]
Age measured in years
Influence of sex on the predicted CBT [48 hours]
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 hairiness on the predicted CBT [48 hours]
Degree of hairiness expressed as mild, moderate and strong
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts 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