Skip to main content
OpenTrials
Completed

NCT Number: NCT05475067

Fever Tracking Study

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitiy Hospital Basel

Basel, Canton of Basel-City, 4031, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

    Time frame: 48 hours

    This comparison will be done for each position of the wearable CBT sensor (apical, upper arm and wrist).

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).

    Time frame: 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 outcomes

  1. Influence of age on the predicted CBT

    Time frame: 48 hours

    Age measured in years

  2. Influence of sex on the predicted CBT

    Time frame: 48 hours

  3. Influence of weight on the predicted CBT

    Time frame: 48 hours

    Weight measured in kg

  4. Influence of height on the predicten CBT

    Time frame: 48 hours

    Height measured in cm

  5. Influence of skin colour on the predicted CBT

    Time frame: 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.

  6. Influence of hairiness on the predicted CBT

    Time frame: 48 hours

    Degree of hairiness expressed as mild, moderate and strong

  7. Influence of food intake on the predicted CBT

    Time frame: 48 hours

    The impact of the above mentioned factor on the CBT will be monitored and recorded in a participant diary

  8. Influence of concomitant medications on the predicted CBT

    Time frame: 48 hours

    The impact of the above mentioned factors on the CBT will be monitored and recorded in a participant diary

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Collaborators

  • greenTEG AG

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 26, 2022
Registry last updated
Jul 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.