Moni-Patch for Core Body Temperature Monitoring
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new device called the Moni-Patch, a small, non-invasive patch that adheres to the neck. It continuously measures core body temperature and aims to match the accuracy of a tympanic (ear) thermometer. The goal is to determine if the Moni-Patch provides consistent and reliable temperature readings. Participants must be at least 7 years old and comfortable wearing sensors on the neck and ear to qualify for this study. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance temperature monitoring technology.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot use antipyretics (fever-reducing drugs) within 120 minutes before the study.
What prior data suggests that the Moni-Patch Temperature Monitoring Patch System is safe for use?
Research shows that the Moni-Patch Temperature Monitoring Patch System is generally safe. Studies have mainly examined skin reactions and device-related issues, and no major problems have emerged. The device is non-invasive, meaning it doesn't enter the body, which typically reduces risks.
Previous studies have shown that the Moni-Patch provides temperature readings comparable to other reliable methods, such as esophageal measurements. This indicates it functions effectively without causing harm. Since the trial focuses on accuracy rather than testing a new drug, the primary safety concerns involve comfort and skin irritation.
Overall, the Moni-Patch appears well-tolerated, with few side effects reported.12345Why are researchers excited about this trial?
Researchers are excited about the Moni-Patch Temperature Monitoring Patch System because it offers a new way to continuously monitor core body temperature. Unlike traditional methods like oral or tympanic thermometers that provide only a single temperature reading, the Moni-Patch allows for continuous and concurrent monitoring by being worn on the neck and using a tympanic sensor in the ear. This could provide more accurate and timely data, which is especially beneficial in clinical settings where rapid changes in body temperature need to be tracked closely.
What evidence suggests that the Moni-Patch is effective for core body temperature monitoring?
Research has shown that the Moni-Patch Temperature Monitoring Patch System, used by participants in this trial, is quite accurate. Earlier studies found that the Moni-Patch closely matched esophageal temperature readings, a trusted method for measuring core body temperature. The data indicated that the Moni-Patch's readings were generally within ±0.4°C of these standard readings, with a range of -1.0°C to 1.0°C. This similarity suggests that the patch's temperature readings align well with traditional methods. Overall, the Moni-Patch could provide a reliable and non-invasive way to monitor core body temperature.12567
Are You a Good Fit for This Trial?
This trial is for individuals aged 7 years or older who are willing to have a temperature monitoring sensor placed on their neck and ear. It's designed to test the accuracy of the Moni-Patch, a non-invasive device for estimating core body temperature.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Acclimation
Participants undergo a minimum 30-minute sensor acclimation period
Concurrent Monitoring
Subjects wear Moni-Patch on the neck and tympanic sensor in the ear for concurrent continuous temperature monitoring
Follow-up
Participants are monitored for any immediate adverse effects post-monitoring session
What Are the Treatments Tested in This Trial?
Interventions
- Moni-Patch Temperature Monitoring Patch System
Trial Overview
The study tests how well the Moni-Patch Temperature Monitoring Patch System estimates core body temperature compared to an FDA-cleared tympanic (ear) thermometer. The goal is to ensure that readings from both methods agree within acceptable limits.
How Is the Trial Designed?
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Treatment groups
Experimental Treatment
Subjects wear Moni-Patch on the neck and tympanic sensor in the ear for concurrent continuous temperature monitoring for 15 minutes after stabilization.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Murata Vios, Inc.
Lead Sponsor
Sonoma State University
Collaborator
Citations
Clinical Accuracy Validation of the Moni-Patch ...
Paired temperature measurements (Moni-Patch vs. Ttym) collected every 30 seconds during continuous monitoring will be analyzed using Bland- ...
Clinical Validation of Moni-Patch TM for Perioperative Core ...
Moni-Patch demonstrated clinically acceptable agreement with esophageal temperature measurements and may serve as a reliable noninvasive ...
Clinical Accuracy Validation of the Moni-Patc Temperature ...
This outcome assesses agreement between the Moni-Patch™ Temperature Monitoring Patch System and clinical reference core temperature measurements ...
A Comprehensive Review of Non-Invasive Core Body ... - PMC
This review is intended for researchers and practitioners who need to select or design CBT monitoring systems. Keywords: core body temperature, ...
Clinical Validation of Moni-Patch TM for Perioperative Core ...
This study aimed to evaluate the accuracy of non-invasive Bair Hugger™ core body temperature monitoring system (BHTMS) at the wrist compared ...
Use of continuous temperature data from wearable devices for ...
When processed with advanced algorithms, this data may reveal subtle temperature fluctuations and thermal patterns that may serve as early ...
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ctv.veeva.com
ctv.veeva.com/study/clinical-accuracy-validation-of-the-moni-patc-temperature-monitoring-patch-during-surgery-comparedClinical Accuracy Validation of the Moni-Patc Temperature ...
This clinical accuracy validation study aims to verify the accuracy and repeatability of the Moni-Patch compared with an FDA-cleared continuous ...
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