BreathingPROOFNCT07614685
Phase Resolved Functional Lung MRI and Oscillometry for the Observation of Healthy Lung Function
An observational study of Breathing and Lung Function Decreased, run by University of Rochester at 1 site in United States.
Trial summary
This study will examine the relationship of airways resistance measured by oscillometry with ventilation defects measured by Phase Resolved Functional Lung (PREFUL) MRI in healthy human subjects. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Breathing, Lung Function Decreased, MRI Imaging
- What is being tested?
- Airway Oscillometer and Phase Resolved Functional Lung MRI
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2026to 1 Jan 2028
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Up to twenty (20) healthy human subjects will be recruited from the outpatient clinics at the University of Rochester Medical Center and the Mary Parkes Asthma Center.
Who may be able to join
- Age 18 years or older
- Ability to provide consent
- Willingness to perform MRI and breathing test
- Must be able to speak and understand English
Who cannot join
- Pregnant
- Unable or willing to provide consent or perform the required maneuvers for testing.
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 Rochester Medical Center
Rochester, New York, 14642
Partick Donohue, MD, 585-210-9301, patrick_donohue@urmc.rochester.edu
About this study
This study will examine the relationship of airways resistance measured by oscillometry with ventilation defects measured by Phase Resolved Functional Lung (PREFUL) MRI in healthy human subjects.
- Conditions
- Breathing, Lung Function Decreased, MRI Imaging, Healthy
- Being tested
- Airway Oscillometer, Phase Resolved Functional Lung MRI
- Medical subject headings
- Respiratory Aspiration, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Airway OscillometerDevice
The termoflo c-100 Airwave Oscillometer System is intended to measure respiratory system impedance using the Forced Oscillation Technique (FOT).
Phase Resolved Functional Lung MRIDiagnostic test
The Phase Resolved Functional Lung (PREFUL) MRI technique acquires images of the lung so that measures of ventilatory defect percentage can be calculated.
| Study group | Role | What they receive |
|---|---|---|
| All participants | Not described Receives: Device: Airway Oscillometer; Diagnostic Test: Phase Resolved Functional Lung MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oscillometer
The oscillometer will collect an airway impedance measurement which is made up of multiple variables.
Measured: Single measurement, approximately 1 day
Phase Resolved Functional Lung (PREFUL) MRI
PREFUL MRI will acquire images of the lungs and a measurement called the ventilatory defect percentage (or VDP) will be calculated.
Measured: Single measurement, approximately 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start1 Sep 2026
- Primary completion1 Jul 2027 (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 BreathingStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patrick Donohue, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07614685
- Sponsor's protocol ID
- STUDY00011843
- Acronym
- PROOF
- Status last verified
- Sep 2026
- First submitted
- 20 May 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Resolved Functional Lung MRI and Oscillometry for the Observation of Healthy Lung Function
- ClinicalTrials.gov ID
- NCT07614685
- Acronym / sponsor ID
- PROOF / STUDY00011843
- Conditions
- Breathing, Lung Function Decreased, MRI Imaging, Healthy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- 1 Sep 2026 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 29 May 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 study will examine the relationship of airways resistance measured by oscillometry with ventilation defects measured by Phase Resolved Functional Lung (PREFUL) MRI in healthy human subjects.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All participants | – | Device: Airway Oscillometer, Diagnostic Test: Phase Resolved Functional Lung MRI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Up to twenty (20) healthy human subjects will be recruited from the outpatient clinics at the University of Rochester Medical Center and the Mary Parkes Asthma Center.
Key inclusion criteria (4 listed)
- Age 18 years or older
- Ability to provide consent
- Willingness to perform MRI and breathing test
- Must be able to speak and understand English
Key exclusion criteria (2 listed)
- Pregnant
- Unable or willing to provide consent or perform the required maneuvers for testing.
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 |
|---|---|---|
| Airway OscillometerThe termoflo c-100 Airwave Oscillometer System is intended to measure respiratory system impedance using the Forced Oscillation Technique (FOT). | Device | All participants |
| Phase Resolved Functional Lung MRIThe Phase Resolved Functional Lung (PREFUL) MRI technique acquires images of the lung so that measures of ventilatory defect percentage can be calculated. | Diagnostic test | All participants |
Primary outcome
Oscillometer
Time frame: Single measurement, approximately 1 day
The oscillometer will collect an airway impedance measurement which is made up of multiple variables.
Phase Resolved Functional Lung (PREFUL) MRI
Time frame: Single measurement, approximately 1 day
PREFUL MRI will acquire images of the lungs and a measurement called the ventilatory defect percentage (or VDP) will be calculated.
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 11 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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?
An observational study of Breathing and Lung Function Decreased, run by University of Rochester 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 4 inclusion and 2 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 11 Sep 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 Patrick Donohue, MD (585-210-9301, patrick_donohue@urmc.rochester.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oscillometer (time frame: Single measurement, approximately 1 day). 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 11 Sep 2026.