Feasibility of Wearable-Based Continuous Temperature Monitoring

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Basel, Switzerland

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Continuous Temperature Monitoring

    Device

    Participants wear investigational temperature sensors and ingest a core temperature capsule continuous data collection

Treatment groups

12 Participants
are divided into 1 treatment group
Group A: Ingestible temperature capsule1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

Data continuity (wearable data)

Percent expected time with usable wearable data

Time frame
Baseline to 48 hours
3

Data continuity (wearable data)

Categorised reasons for missing/invalid data

Time frame
Baseline to 48 hours
4

Data continuity (capsule data)

frequency/duration of gaps

Time frame
Baseline to 48 hours

Other outcomes

Sponsors and contacts

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