Fever Tracking Study

NCT05475067 | Completed

• 1 other identifier: Fever Tracking
• Study Type: observational
• Target: 61
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Mean absolute error, mean bias and standard deviation of the predicted CBT sensor compared to the reference temperature method (ingestible electronic pill).

  48 hours

Other Outcomes (8)

• Influence of age on the predicted CBT

  48 hours

• Influence of sex on the predicted CBT

  48 hours

• Influence of weight on the predicted CBT

  48 hours

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• Age 18-60 years old
• Informed consent signed
• Either:

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• greenTEG AG: collaborator

Study Sites (1)

Universitiy Hospital Basel

Basel, Canton of Basel-City, 4031, Switzerland

Location

Study Officials

• Jens Eckstein, Prof. Dr.

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2022
• First Posted: July 26, 2022
• Study Start: October 7, 2021
• Primary Completion: March 3, 2022
• Study Completion: March 5, 2022
• Last Updated: July 26, 2022

Record last verified: 2022-07

Locations

CH (1)