Temperature Change, Body
Conditions
Keywords
Continuous temperature monitoring, Wearable devices, Feasibility study, Ingestible temperature capsule, Real-world monitoring
Brief summary
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.
Detailed description
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.
Interventions
Participants wear investigational temperature sensors and ingest a core temperature capsule continuous data collection
Sponsors
University Hospital, Basel, Switzerland
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
* Written informed consent obtained prior to any project-specific procedures. * Age 18 years or older at enrolment. * Able and willing to comply with project procedures, including capsule ingestion, continuous wearable use for around 48 hours, and adherence to study instructions. * Able to swallow the ingestible temperature capsule without difficulty. * No contraindication to ingestible thermometry as assessed by the investigator.
Exclusion criteria
General: * Body weight \< 36 kg. * Women who are pregnant. * Participation in another clinical investigation involving an investigational medicinal product or medical device within the 30 days preceding enrolment or previous enrolment in the current project. * Enrolment of the Principal Investigator, project staff, their family members, employees, or other dependent persons. * Inability to provide valid informed consent or significant language barrier preventing adequate understanding of procedures. Implants \& MRI: * Presence of any active Implantable Medical Device (AIMD), including Pacemakers, Implantable Cardioverter Defibrillators (ICDs), Deep Brain Stimulation (DBS) devices, or Left Ventricular Assist Devices (LVADs). * Requirement for MRI scanning during the seven days following the capsule intake. Cognitive/Physical Status: * Unconscious patients (prior to ingestion). * Patients with special needs or disabilities preventing safe autonomous swallowing. Gastrointestinal: * Known history of dysphagia or gag reflex troubles. * Previous gastrointestinal surgery resulting in bowel stenosis. * Current or planned surgical procedures on the GI tract (esophagus, stomach, intestines). * Zenker's diverticulum or felinization of the esophagus. * Risk or history of intestinal obstruction, strictures, or diverticula. * Hypomotility disorders (e.g., ileus). * Inflammatory Bowel Diseases including Crohn's disease or Ulcerative Colitis. Dermatological Exclusions (Rheo Vital+ Performance) * Dermatological conditions, wounds, tattoos, oedema, inflammation, active venous access, or other impairments at the medial upper arm or axillary region that could interfere with correct placement or functioning of the wearable device. * Excessive hair or concurrent devices that hinder correct sensor placement. * Known allergy to plastics or latex. Temperature Management: * Active external heating or cooling (e.g., cooling blankets). * Note: Use of pharmacological antipyretics (oral/IV) is permitted. Further Medical Conditions: * Currently existing acute back pain. * Symptomatic herniated disc.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Paired Continuous Temperature Data Completeness | Baseline to 48 hours | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment and Retention Feasibility | Baseline to 48 hours | Proportion of eligible participants enrolled among those approached and proportion of enrolled participants completing the planned monitoring period. |
| Data continuity (wearable data) | Baseline to 48 hours | Percent expected time with usable wearable data |
| Data continuity (capsule data) | Baseline to 48 hours | frequency/duration of gaps |
| Time-alignment success between wearable and capsule streams | Baseline to 48 hours | Success rate of time synchronisation |
| Data retrieval workflow | Baseline to 48 hours | Success rate of secure data retrieval/transfer |
| Tolerability Questionnair | Baseline to 48 hours | Participant-reported tolerability and wear adherence assessed by a questionnaire |
| Tolerability: skin discomfort | Baseline to 48 hours | Incidence and nature of wearable skin discomfort |
| Tolerability: GI discomfort | Baseline to 48 hours | Capsule-related GI discomfort/delayed excretion (descriptive) |
| Observed temperature trajectories | Baseline to 48 hours | Descriptive summaries of temperature time courses; whether transient elevations \>38.0°C were captured |
| Baseline factors considered (descriptive stratification only) | Baseline to 48 hours | Age and sex will be explored descriptively as potential drivers of data quality metrics |
Countries
Switzerland
Contacts
CONTACTJens Eckstein, Prof. MD
STUDY_CHAIRJens Eckstein, Prof. MD
University Hospital of Basel
Outcome results
None listed