Accuracy of Moni-Patch Compared With Tympanic Temperature Monitoring in Adults at Risk of Fever

NCT07900386 · tracked via the Priya Life Science USA tracker

Sponsor

Murata Vios, Inc

Phase

Not applicable

Started

2027-01-01

Last updated

2026-10-28

Condition(s) studied

FeverTemperature Monitoring

Investigational drug(s) / intervention(s)

Moni-Patch Temperature Monitoring Patch SystemContinuous Tympanic Temperature Monitoring System

Moni-Patch Temperature Monitoring Patch System: A non-invasive wearable temperature monitoring sensor applied to the neck over the carotid region. Temperature will be monitored continuously for up to 24 hours.

Continuous Tympanic Temperature Monitoring System: An FDA-cleared continuous tympanic temperature monitoring system used as the clinical reference temperature measurement. The sensor will be placed in the ear and used concurrently with Moni-Patch for up to 24 hours.

Study summary

This single-center, prospective clinical accuracy study evaluates the agreement between the Moni-Patch Temperature Monitoring Patch System and continuous tympanic temperature monitoring in adults at increased risk of developing fever during ICU care. Moni-Patch and an FDA-cleared continuous tympanic temperature sensor will be used concurrently for up to 24 hours. Agreement between the two temperature measurements will be evaluated using Bland-Altman analysis during a predefined febrile measurement window.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: Age ≥18 years. Subject agrees to temperature sensor placement on the neck and ear. Subject is expected to receive ICU care and is considered by the clinical/research team to be at risk of developing fever during the monitoring period. The Moni-Patch sensor must be able to maintain an uninterrupted wireless connection with the Exclusion Criteria: Conditions of the ear that contraindicate placement of the tympanic temperature monitoring probe/sensor. Medical conditions such as inflammation, scratches, redness, or rash at the sensor placement sites. Use of barbiturates, thyroid preparations, antipsychotics, or recent immunizations. Inability to securely adhere the Moni-Patch sensor to the skin or accurately position it over the carotid artery. Inability to properly seal the tympanic membrane temperature sensor with film dressing. Tympanic membrane cannot be visually confirmed using a microscope.

Primary outcome measure(s)

Agreement Between Moni-Patch and Tympanic Core Temperature Measurements During Fever — During up to 24 hours of continuous monitoring after sensor application; the primary analysis will use the earliest qualifying 30-pair febrile measurement window after the initial 30-minute stabilization period.
Agreement between Moni-Patch and continuous tympanic temperature measurements will be assessed using Bland-Altman analysis. The analysis will estimate the mean temperature difference (bias) and 95% limits of agreement (LOA). The predefined performance targets are bias within ±0.4°C and limits of agreement within -1.0°C to +1.0°C.

Trial sites (1)

Facility	City	Region	Status
University of Minnesota Medical Center	Minneapolis	Minnesota

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07900386 on ClinicalTrials.gov ↗ ← All trials in the USA