An interventional study of Moni-Patch Temperature Monitoring Patch System and Continuous Tympanic Temperature Monitoring System in Fever and Temperature Monitoring, sponsored by Murata Vios, Inc.. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by Murata Vios, Inc. · Not applicable, Interventional, and Diagnostic
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.
Adult participants considered at increased risk of developing fever during ICU care may be enrolled before the onset of fever. Following ICU admission, the Moni-Patch sensor and an FDA-cleared continuous tympanic temperature reference sensor will be applied and monitored concurrently for up to 24 hours.
The first 30 minutes after Moni-Patch application will be considered a stabilization period and excluded from the primary accuracy analysis. After stabilization, consecutive windows containing 30 simultaneous paired Moni-Patch and tympanic temperature observations will be evaluated. The earliest window in which at least 75% of tympanic reference measurements are ≥38.0°C will be used for the primary accuracy analysis.
Agreement will be assessed using Bland-Altman analysis of bias and 95% limits of agreement.
438 studies on the registry are indexed under Fever; 55 are open to participants now.
This study's planned enrollment of 35 is below the median of 123 across 271 interventional studies indexed under Fever.
Browse Fever studies →Murata Vios, Inc. is the lead sponsor of 4 studies on the registry; 4 are open to participants now.
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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.
Participants will undergo concurrent continuous temperature monitoring using the investigational Moni-Patch Temperature Monitoring Patch System and an FDA-cleared tympanic temperature monitoring system as the reference device. Both devices will be applied during ICU care, and temperature data will be collected for up to 24 hours to evaluate agreement between the two measurement methods.
Device: Moni-Patch Temperature Monitoring Patch System · Device: Continuous Tympanic Temperature Monitoring 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.
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.
Agreement Between Moni-Patch and Tympanic Core Temperature Measurements During Fever
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.
Time frame: 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.
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Murata Vios, Inc.