About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
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.
Trial design
Cohort
Prospective
Treatments tested in this trial
Continuous Temperature Monitoring
DeviceParticipants wear investigational temperature sensors and ingest a core temperature capsule continuous data collection
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Recruitment and Retention Feasibility
Proportion of eligible participants enrolled among those approached and proportion of enrolled participants completing the planned monitoring period.
Data continuity (wearable data)
Percent expected time with usable wearable data
Data continuity (wearable data)
Categorised reasons for missing/invalid data
Data continuity (capsule data)
frequency/duration of gaps
Sponsors and contacts
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