Core Body Temperature in Healthy SubjectsNCT05475067
Fever Tracking Study
An observational study of Core Body Temperature in Healthy Subjects and Immune Response to mRNA COVID-19 Vaccination, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Core Body Temperature in Healthy Subjects, Immune Response to mRNA COVID-19 Vaccination
- How many people
- 61 participants
- Where
- 1 siteSwitzerland
- Study dates
- 7 Oct 2021to 5 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Universitiy Hospital Basel
Basel, Canton of Basel-City, 4031
About this study
Official title: Fever Tracking Study: The Feasibility of Fever Tracking in a Home-setting by a Non-invasive Wearable Core Body Temperature Sensor
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.
- Keywords
- Fever Tracking, Core body temperature CBT, mRNA COVID-19 vaccination, Wearable sensors, Wearables
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
In addition to the primary outcome measure, the heartrate will be used as additional input to perform the CBT prediction of the wearables.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2022
- Study start7 Oct 2021
- Primary completion3 Mar 2022
- Study completion5 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Core Body Temperature in Healthy SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- greenTEG AG
- Responsible party
- Sponsor
- Investigators
- Jens Eckstein, Prof. Dr., Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05475067
- Sponsor's protocol ID
- Fever Tracking
- Status last verified
- Jul 2022
- First submitted
- 1 Jun 2022
- Last updated
- 26 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fever Tracking Study: The Feasibility of Fever Tracking in a Home-setting by a Non-invasive Wearable Core Body Temperature Sensor
- ClinicalTrials.gov ID
- NCT05475067
- Acronym / sponsor ID
- Fever Tracking
- Keywords
- Fever Tracking, Core body temperature CBT, mRNA COVID-19 vaccination, Wearable sensors, Wearables
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- greenTEG AG
- Study start
- 7 Oct 2021 (actual)
- Primary completion
- 3 Mar 2022 (actual)
- Study completion
- 5 Mar 2022 (actual)
- First posted
- 26 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2022.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jens Eckstein, Prof. Dr. principal investigator
University Hospital, Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Core Body Temperature in Healthy Subjects and Immune Response to mRNA COVID-19 Vaccination, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2022.