Acute Respiratory IllnessNCT07902115
Vocxi Breath Analyzer Study in Pediatric Respiratory Infection
A study testing MBP® Breath Analyzer in people with Acute Respiratory Illness and Viral Respiratory Infection, run by University of Minnesota at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 7 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Respiratory Illness, Viral Respiratory Infection
- What is being tested?
- MBP® Breath Analyzer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Oct 2026to 1 Mar 2027
- 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 7 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age 7 to 17 years
- Able to participate in study procedures, including breathing comfortably into the MBP® Breath Analyzer for 1 minute
- Meets the case definition of acute respiratory illness, defined as two or more of the following signs or symptoms: fever, cough, runny nose, nasal congestion, or sore throat
- Age 7 to 17 years
- Able to participate in study procedures, including breathing comfortably into the MBP® Breath Analyzer for 1 minute
- Does not have symptoms of acute respiratory illness
- Has not had symptoms of acute respiratory illness within the past month by parent or patient report
- Being seen in the Emergency Department for a minor injury, such as ankle sprain or laceration, with plan to discharge from the Emergency Department
Who cannot join
- Unable to comfortably breathe normally into the MBP® Breath Analyzer for 1 minute
- Has eaten in the 30 minutes prior to use
- Has smoked in the 2 hours prior to use
- Primary diagnosis or parent concern in the Emergency Department is asthma or reactive airway disease
- History of or current cancer of any kind
- Current smoke inhalation injury
Show all 15Show fewer
- Current concern for a drowning event
- Current concern for a drug overdose
- Requiring oxygen in the Emergency Department
- Current tracheostomy in place
- Non-English speaker
- Prisoner
- Active member of the military or DoD personnel
- Patient with research opt-out status in the medical record
- ESI score of 1 or 2
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, 1 recruiting
- Recruiting
University of Minnesota Masonic Children's Hospital Pediatric Emergency Department
Minneapolis, Minnesota, 55454
Gwenyth Fischer, 612-625-6678, fisch662@umn.edu
About this study
Official title: Vocxi Breath Analyzer Study
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.
Read the detailed description
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.
- Being tested
- MBP® Breath Analyzer
- Keywords
- MBP Breath Analyzer, Volatile organic compounds, VOC, ARI, Upper respiratory infection
- Medical subject headings
- Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MBP® Breath AnalyzerDevice
Also called MyBreathPrint® System
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.
| Study group | Role | What they receive |
|---|---|---|
| Acute Respiratory Illness Group | Experimental | 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. Receives: Device: MBP® Breath Analyzer |
| Healthy Control Group | Experimental | 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. Receives: Device: MBP® Breath Analyzer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: During the study visit, approximately 45 minutes
Secondary outcomes (1)
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.
Measured: During the study visit, approximately 45 minutes
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 start27 Oct 2026
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory IllnessStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Pediatric participants aged 7 to 17 years presenting to the Masonic Children's Hospital Pediatric Emergency Department will be enrolled into one of two non-randomized groups: participants with signs or symptoms of acute respiratory illness and healthy controls presenting for minor injuries without respiratory symptoms. All participants will provide a breath sample using the MBP® Breath Analyzer. VOC signal patterns will be compared between groups.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gwenyth Fischer, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07902115
- Sponsor's protocol ID
- PEDS-2026-34648
- Status last verified
- Oct 2026
- First submitted
- 1 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vocxi Breath Analyzer Study
- ClinicalTrials.gov ID
- NCT07902115
- Acronym / sponsor ID
- PEDS-2026-34648
- Keywords
- MBP Breath Analyzer, Volatile organic compounds, VOC, ARI, Upper respiratory infection
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 27 Oct 2026 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2027 (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 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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pediatric participants aged 7 to 17 years presenting to the Masonic Children's Hospital Pediatric Emergency Department will be enrolled into one of two non-randomized groups: participants with signs or symptoms of acute respiratory illness and healthy controls presenting for minor injuries without respiratory symptoms. All participants will provide a breath sample using the MBP® Breath Analyzer. VOC signal patterns will be compared between groups.
| Arm | Type | Receives |
|---|---|---|
| Acute Respiratory Illness Group | Experimental | Device: MBP® Breath AnalyzerPediatric 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. |
| Healthy Control Group | Experimental | Device: MBP® Breath AnalyzerPediatric 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. |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Age 7 to 17 years
- Able to participate in study procedures, including breathing comfortably into the MBP® Breath Analyzer for 1 minute
- Meets the case definition of acute respiratory illness, defined as two or more of the following signs or symptoms: fever, cough, runny nose, nasal congestion, or sore throat
- Age 7 to 17 years
- Able to participate in study procedures, including breathing comfortably into the MBP® Breath Analyzer for 1 minute
Key exclusion criteria (15 listed)
- Unable to comfortably breathe normally into the MBP® Breath Analyzer for 1 minute
- Has eaten in the 30 minutes prior to use
- Has smoked in the 2 hours prior to use
- Primary diagnosis or parent concern in the Emergency Department is asthma or reactive airway disease
- History of or current cancer of any kind
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 |
|---|---|---|
| MBP® Breath AnalyzerAlso: MyBreathPrint® SystemThe 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. | Device | Acute Respiratory Illness Group, Healthy Control Group |
Primary outcome
Successful Breath Sample Collection Using the MBP® Breath Analyzer
Time frame: During the study visit, approximately 45 minutes
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.
Measurable VOC Signals From Pediatric Breath Samples
Time frame: During the study visit, approximately 45 minutes
Device performance will be assessed by whether breath samples collected using the MBP® Breath Analyzer produce measurable volatile organic compound signal data.
1 secondary outcome
VOC Signal Differences Between Acute Respiratory Illness and Healthy Control Groups
Time frame: During the study visit, approximately 45 minutes
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 2 Nov 2026.
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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.
Gwenyth Fischer principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MBP® Breath Analyzer in people with Acute Respiratory Illness and Viral Respiratory Infection, run by University of Minnesota 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 8 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 2 Nov 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 Gwenyth Fischer (612-625-6678, fisch662@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful Breath Sample Collection Using the MBP® Breath Analyzer (time frame: During the study visit, approximately 45 minutes). The study lists 2 primary outcomes in all. 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 2 Nov 2026.