Feasibility of Wearable-Based Continuous Temperature Monitoring

Official title

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

Overview

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

• Device Continuous Temperature Monitoring
  Participants wear investigational temperature sensors and ingest a core temperature capsule continuous data collection

Primary outcome measures

• Paired Continuous Temperature Data Completeness [Time frame: Baseline to 48 hours]

Secondary outcome measures (12)

• Recruitment and Retention Feasibility [Time frame: Baseline to 48 hours]
• Data continuity (wearable data) [Time frame: Baseline to 48 hours]
• Data continuity (wearable data) [Time frame: Baseline to 48 hours]
• Data continuity (capsule data) [Time frame: Baseline to 48 hours]
• Data continuity (capsule data) [Time frame: Baseline to 48 hours]
• Data continuity (capsule data) [Time frame: Baseline to 48 hours]
• Time-alignment success between wearable and capsule streams [Time frame: Baseline to 48 hours]
• Time-alignment success between wearable and capsule streams [Time frame: Baseline to 48 hours]
• Data retrieval workflow [Time frame: Baseline to 48 hours]
• Data retrieval workflow [Time frame: Baseline to 48 hours]
• Data retrieval workflow [Time frame: Baseline to 48 hours]
• Tolerability Questionnair [Time frame: Baseline to 48 hours]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model

Cohort

Study locations

Switzerland · 1 center

• University Hospital Basel — Basel

Identifiers

NCT: NCT07397988 · am25Eckstein4

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗