An interventional study of MBP® Breath Analyzer in Acute Respiratory Illness and Viral Respiratory Infection, sponsored by University of Minnesota. Recruiting at 1 site in United States. Open to participants aged 7 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by University of Minnesota · Not applicable, Interventional, and Diagnostic
This pilot study will evaluate whether the MBP® Breath Analyzer can collect measurable volatile organic compound signals from pediatric participants with acute respiratory illness and from healthy pediatric controls.
Children aged 7 to 17 years presenting to the Masonic Children's Hospital Pediatric Emergency Department will be enrolled. One group will include participants with signs or symptoms of acute respiratory illness, and the control group will include participants presenting for minor injuries without respiratory symptoms.
Participants will breathe normally into the MBP® Breath Analyzer for approximately 1 minute. VOC signal data will be analyzed to assess device performance and to explore whether breath VOC patterns differ between pediatric participants with respiratory infection and healthy controls.
Volatile organic compounds are produced by metabolic processes and may vary across disease states, including infections. The MBP® Breath Analyzer is designed to detect volatile organic compound patterns in exhaled breath using graphene-based nanosensors and pattern recognition algorithms.
This prospective pilot study will evaluate the feasibility and performance of the MBP® Breath Analyzer in pediatric participants. The study will enroll up to 20 children aged 7 to 17 years in the Masonic Children's Hospital Pediatric Emergency Department. Up to 10 participants will have signs or symptoms of acute respiratory illness, and up to 10 participants will serve as healthy controls presenting for minor injuries without respiratory symptoms.
After parental permission and child assent are obtained, participants will breathe normally into a mask connected to the MBP® Breath Analyzer for approximately 1 minute. The device sends sensor data to a secure dedicated study phone containing the Vocxi app. VOC signal data will be uploaded to Vocxi's secure web portal using a study ID only and analyzed with proprietary pattern recognition software.
The primary objective is to assess whether the MBP® Breath Analyzer can successfully collect measurable breath VOC profiles from pediatric participants with acute respiratory illness and healthy controls. Secondary and exploratory analyses will compare VOC signal patterns between participants with respiratory infection and healthy controls and explore whether VOC patterns are associated with specific infectious agents identified through clinical testing or residual clinical specimens.
751 studies on the registry are indexed under Respiratory Tract Infections; 114 are open to participants now.
This study's planned enrollment of 20 is below the median of 200 across 540 interventional studies indexed under Respiratory Tract Infections.
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Inclusion Criteria for Acute Respiratory Illness Group::
Inclusion Criteria for Control Group:
Exclusion Criteria:
Pediatric participants aged 7 to 17 years with signs or symptoms of acute respiratory illness will provide a breath sample using the MBP® Breath Analyzer. Acute respiratory illness is defined as two or more of the following: fever, cough, runny nose, nasal congestion, or sore throat.
Device: MBP® Breath Analyzer
Pediatric participants aged 7 to 17 years presenting to the Emergency Department for minor injuries and without current or recent acute respiratory illness symptoms will provide a breath sample using the MBP® Breath Analyzer.
Device: MBP® Breath Analyzer
The MBP® Breath Analyzer is a handheld breath sensor connected to a secure dedicated study mobile phone with the Vocxi app. A mask is connected to the device, and the participant breathes normally into the mask for approximately 1 minute. The system collects volatile organic compound signal data from exhaled breath for research analysis. The device will not be used to diagnose, treat, or guide clinical care.
Also known as: MyBreathPrint® System
Successful Breath Sample Collection Using the MBP® Breath Analyzer
Successful breath sample collection will be assessed by the number and proportion of participants who are able to complete breath collection using the MBP® Breath Analyzer.
Time frame: During the study visit, approximately 45 minutes
Measurable VOC Signals From Pediatric Breath Samples
Device performance will be assessed by whether breath samples collected using the MBP® Breath Analyzer produce measurable volatile organic compound signal data.
Time frame: During the study visit, approximately 45 minutes
VOC Signal Differences Between Acute Respiratory Illness and Healthy Control Groups
VOC chemical signals collected using the MBP® Breath Analyzer will be compared between pediatric participants with acute respiratory illness and healthy pediatric controls.
Time frame: During the study visit, approximately 45 minutes
Difference in Breath Sensor-Response Patterns Between Acute Respiratory Illness and Healthy Control Groups
Breath sensor-response patterns will be assessed using volatile organic compound (VOC) signals collected from participants with acute respiratory illness and healthy control participants. Exploratory analyses will compare the sensor-response patterns between these two groups to identify differences in VOC signal profiles.
Time frame: 72 hours post hospital admission
PDFs hosted by the registry, ClinicalTrials.gov.
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 ↗
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