Feasibility of Wearable-Based Continuous Temperature Monitoring

Feasibility Study for Logistics and Data Stability of Continuous Temperature Monitoring Using a Wearable Device With a Continuous Core Temperature Reference Method

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Temperature Change, Body
• Intervention / Treatment: Device: Continuous Temperature Monitoring

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.

• Study Type: Observational
• Enrollment (Estimated): 12

Contacts and Locations

• Study Contact: Name: Jens Eckstein, Prof. MD; Phone Number: 0041-61-3287689; Email: jens.eckstein@usb.ch

Study Locations

• Switzerland
  • Basel, Switzerland, 4031
    • University Hospital Basel
    • Contact: Jens Eckstein, Prof. MD.; Phone Number: 0041-61-3287689; Email: jens.eckstein@usb.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Ingestible temperature capsule	Device: Continuous Temperature Monitoring; Participants wear investigational temperature sensors and ingest a core temperature capsule continuous data collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment and Retention Feasibility	Proportion of eligible participants enrolled among those approached and proportion of enrolled participants completing the planned monitoring period.	Baseline to 48 hours
Data continuity (wearable data)	Percent expected time with usable wearable data	Baseline to 48 hours
Data continuity (wearable data)	Categorised reasons for missing/invalid data	Baseline to 48 hours
Data continuity (capsule data)	frequency/duration of gaps	Baseline to 48 hours
Data continuity (capsule data)	Percent expected time with usable capsule data	Baseline to 48 hours
Data continuity (capsule data)	Categorised reasons for missing/invalid data	Baseline to 48 hours
Time-alignment success between wearable and capsule streams	Success rate of time synchronisation	Baseline to 48 hours
Time-alignment success between wearable and capsule streams	Distribution of residual alignment error after the defined alignment procedure (reported descriptively).	Baseline to 48 hours
Data retrieval workflow	Success rate of secure data retrieval/transfer	Baseline to 48 hours
Data retrieval workflow	Number of troubleshooting events	Baseline to 48 hours
Data retrieval workflow	Time spent per participant	Baseline to 48 hours
Tolerability Questionnair	Participant-reported tolerability and wear adherence assessed by a questionnaire	Baseline to 48 hours
Tolerability: skin discomfort	Incidence and nature of wearable skin discomfort	Baseline to 48 hours
Tolerability: GI discomfort	Capsule-related GI discomfort/delayed excretion (descriptive)	Baseline to 48 hours
Observed temperature trajectories	Descriptive summaries of temperature time courses; whether transient elevations >38.0°C were captured	Baseline to 48 hours
Baseline factors considered (descriptive stratification only)	Age and sex will be explored descriptively as potential drivers of data quality metrics	Baseline to 48 hours
Baseline factors considered (descriptive stratification only)	Age and sex will be explored descriptively as potential drivers of observed temperature dynamics.	Baseline to 48 hours

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Investigators: Study Chair: Jens Eckstein, Prof. MD, University Hospital of Basel

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: January 22, 2026
• First Submitted That Met QC Criteria: February 2, 2026
• First Posted (Actual): February 9, 2026

Study Record Updates

• Last Update Posted (Actual): February 9, 2026
• Last Update Submitted That Met QC Criteria: February 2, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Feasibility study; Wearable devices; Continuous temperature monitoring; Ingestible temperature capsule; Real-world monitoring
• Additional Relevant MeSH Terms: Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Body Temperature Changes
• Other Study ID Numbers: am25Eckstein4

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No