FeverNCT07900386
Accuracy of Moni-Patch Compared With Tympanic Temperature Monitoring in Adults at Risk of Fever
A study testing Moni-Patch Temperature Monitoring Patch System and Continuous Tympanic Temperature Monitoring System in people with Fever and Temperature Monitoring, run by Murata Vios, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fever, Temperature Monitoring
- What is being tested?
- Moni-Patch Temperature Monitoring Patch System and Continuous Tympanic Temperature Monitoring System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2027to 1 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Minnesota Medical Center
Minneapolis, Minnesota, 55455
About this study
Official title: Moni-Patch Temperature Monitoring Patch System Clinical Accuracy Validation
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.
Read the detailed description
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.
- Conditions
- Fever, Temperature Monitoring
- Being tested
- Moni-Patch Temperature Monitoring Patch System, Continuous Tympanic Temperature Monitoring System
- Keywords
- core body temperature, Fever, Intensive Care Unit, Continuous Temperature Monitoring, Tympanic Temperature
- Medical subject headings
- Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moni-Patch Temperature Monitoring Patch SystemDevice
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 SystemDevice
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 group | Role | What they receive |
|---|---|---|
| Moni-Patch and Tympanic Temperature Monitoring | Experimental | 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. Receives: Device: Moni-Patch Temperature Monitoring Patch System; Device: Continuous Tympanic Temperature Monitoring System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study start1 Jan 2027 (estimated)
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FeverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Murata Vios, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Minnesota
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07900386
- Sponsor's protocol ID
- MPS2_01_UoM
- Other IDs
- MPS2_01
- Status last verified
- Oct 2026
- First submitted
- 21 Oct 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Moni-Patch Temperature Monitoring Patch System Clinical Accuracy Validation
- ClinicalTrials.gov ID
- NCT07900386
- Acronym / sponsor ID
- MPS2_01_UoM
- Conditions
- Fever, Temperature Monitoring
- Keywords
- core body temperature, Fever, Intensive Care Unit, Continuous Temperature Monitoring, Tympanic Temperature
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Murata Vios, Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of Minnesota
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 28 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Moni-Patch and Tympanic Temperature Monitoring | Experimental | Device: Moni-Patch Temperature Monitoring Patch System, Device: Continuous Tympanic Temperature Monitoring SystemParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moni-Patch Temperature Monitoring Patch SystemA non-invasive wearable temperature monitoring sensor applied to the neck over the carotid region. Temperature will be monitored continuously for up to 24 hours. | Device | Moni-Patch and Tympanic Temperature Monitoring |
| Continuous Tympanic Temperature Monitoring SystemAn 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. | Device | Moni-Patch and Tympanic Temperature Monitoring |
Primary outcome
Agreement Between Moni-Patch and Tympanic Core Temperature Measurements During Fever
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moni-Patch Temperature Monitoring Patch System and Continuous Tympanic Temperature Monitoring System in people with Fever and Temperature Monitoring, run by Murata Vios, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ash Shibata (6124977397, a.shibata@murata.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement Between Moni-Patch and Tympanic Core Temperature Measurements During Fever (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.