An observational study in Temperature Change, Body, sponsored by University Hospital, Basel, Switzerland. Not yet recruiting at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-09.
Sponsored by University Hospital, Basel, Switzerland · Observational
The aim of this study is to evaluate the feasibility of collecting synchronised continuous temperature data using wearable devices and a continuous core temperature reference under real-world conditions. The study focuses on workflow execution, data continuity, secure retrieval, and time-alignment without diagnostic or therapeutic intent.
Continuous temperature monitoring in real-world and free-living settings is operationally challenging due to intermittent standard measurements and context-dependent variability. This limits the ability to evaluate the integrity and stability of continuous temperature time-series and to test end-to-end data collection workflows.
This feasibility study is conducted to determine whether synchronised continuous temperature data from wearable devices and an ingestible core temperature reference can be collected, time-aligned, and retrieved reliably with acceptable participant and staff burden. The study generates feasibility evidence on workflow performance and data stability to inform the design of a subsequent confirmatory clinical investigation.
97 studies on the registry are indexed under Body Temperature Changes; 20 are open to participants now.
This study's planned enrollment of 12 is below the median of 87 across 24 observational studies indexed under Body Temperature Changes.
Browse Body Temperature Changes studies →University Hospital, Basel, Switzerland is the lead sponsor of 990 studies on the registry; 189 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult participants (≥18 years) capable of providing informed consent and willing to comply with the project procedures, including ingestion of the capsule and continuous wearing of two wearable devices for around 48 hours until capsule excretion under free-living conditions.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
General:
Implants \& MRI:
Cognitive/Physical Status:
Gastrointestinal:
Dermatological Exclusions (Rheo Vital+ Performance)
Temperature Management:
Further Medical Conditions:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Continuous Temperature Monitoring
Participants wear investigational temperature sensors and ingest a core temperature capsule continuous data collection
Paired Continuous Temperature Data Completeness
Participant-level paired data completeness (%) over the planned monitoring period, defined as the proportion of monitoring minutes with usable and time-aligned temperature data from both the wearable device(s) and the ingestible capsule.
Time frame: Baseline to 48 hours
Recruitment and Retention Feasibility
Proportion of eligible participants enrolled among those approached and proportion of enrolled participants completing the planned monitoring period.
Time frame: Baseline to 48 hours
Data continuity (wearable data)
Percent expected time with usable wearable data
Time frame: Baseline to 48 hours
Data continuity (wearable data)
Categorised reasons for missing/invalid data
Time frame: Baseline to 48 hours
Data continuity (capsule data)
frequency/duration of gaps
Time frame: Baseline to 48 hours
Data continuity (capsule data)
Percent expected time with usable capsule data
Time frame: Baseline to 48 hours
Data continuity (capsule data)
Categorised reasons for missing/invalid data
Time frame: Baseline to 48 hours
Time-alignment success between wearable and capsule streams
Success rate of time synchronisation
Time frame: Baseline to 48 hours
Time-alignment success between wearable and capsule streams
Distribution of residual alignment error after the defined alignment procedure (reported descriptively).
Time frame: Baseline to 48 hours
Data retrieval workflow
Success rate of secure data retrieval/transfer
Time frame: Baseline to 48 hours
Data retrieval workflow
Number of troubleshooting events
Time frame: Baseline to 48 hours
Data retrieval workflow
Time spent per participant
Time frame: Baseline to 48 hours
Tolerability Questionnair
Participant-reported tolerability and wear adherence assessed by a questionnaire
Time frame: Baseline to 48 hours
Tolerability: skin discomfort
Incidence and nature of wearable skin discomfort
Time frame: Baseline to 48 hours
Tolerability: GI discomfort
Capsule-related GI discomfort/delayed excretion (descriptive)
Time frame: Baseline to 48 hours
Observed temperature trajectories
Descriptive summaries of temperature time courses; whether transient elevations \>38.0°C were captured
Time frame: Baseline to 48 hours
Baseline factors considered (descriptive stratification only)
Age and sex will be explored descriptively as potential drivers of data quality metrics
Time frame: Baseline to 48 hours
Baseline factors considered (descriptive stratification only)
Age and sex will be explored descriptively as potential drivers of observed temperature dynamics.
Time frame: Baseline to 48 hours
This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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