Feasibility of Wearable-Based Continuous Temperature Monitoring

NCT07397988 | Not Yet Recruiting

• 1 other identifier: am25Eckstein4
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Temperature Change, Body

Keywords

Continuous temperature monitoring; Wearable devices; Feasibility study; Ingestible temperature capsule; Real-world monitoring

Outcome Measures

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.

  Baseline to 48 hours

Secondary Outcomes (17)

• Recruitment and Retention Feasibility

  Baseline to 48 hours

• Data continuity (wearable data)

  Baseline to 48 hours

• Data continuity (wearable data)

  Baseline to 48 hours

• Data continuity (capsule data)

  Baseline to 48 hours

• Data continuity (capsule data)

  Baseline to 48 hours

Study Arms (1)

Ingestible temperature capsule

Device: Continuous Temperature Monitoring

Interventions

Continuous Temperature Monitoring DEVICE

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

Ingestible temperature capsule

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

University Hospital Basel

Basel, 4031, Switzerland

Location

MeSH Terms

Conditions

Body Temperature Changes

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jens Eckstein, Prof. MD

  University Hospital of Basel

  STUDY CHAIR

Central Study Contacts

Jens Eckstein, Prof. MD

CONTACT

0041-61-3287689; jens.eckstein@usb.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2026
• First Posted: February 9, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: February 9, 2026

Record last verified: 2026-02

Locations

CH (1)