Breathing, MouthCOEDNCT06554353
Cardiopulmonary Exercise Testing and Oscillometry for the Evaluation of Dyspnea
An observational study of Breathing, Mouth and Lung Function Decreased, run by University of Rochester at 1 site in United States.
Trial summary
This study will determine if airway resistance to airflow and pressure, measured by Oscillometry, is associated with abnormal findings on Cardiopulmonary Exercise Testing in subjects who are experiencing shortness of breath. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breathing, Mouth, Lung Function Decreased, Dyspnea
- What is being tested?
- Oscillometer
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Oct 2024to 30 Nov 2026
- 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
- Adult, Older adult
Study population: Up to fifty (50) human subjects will be recruited from the following University of Rochester locations: Mary Parkes Center for Asthma, Allergy, and Pulmonary Care, the Pulmonary Clinic at Strong Memorial Hospital, and The Pulmonary Clinic at Highland Hospital.
Who may be able to join
- Willingness to perform breathing test
- Must be able to speak and understand English
- Referred for Cardiopulmonary Exercise Testing
Who cannot join
- Unable to provide consent or perform oscillometry test
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
Highland Hospital
Rochester, New York, 14620
PATRICK A DONOHUE, MD, 5853416774, patrick_donohue@urmc.rochester.edu
About this study
This study will determine if airway resistance to airflow and pressure, measured by Oscillometry, is associated with abnormal findings on Cardiopulmonary Exercise Testing in subjects who are experiencing shortness of breath.
- Being tested
- Oscillometer
- Medical subject headings
- Mouth Breathing, Respiratory Insufficiency, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OscillometerDevice
Also called THORASYS tremoFlo C-100 Airwave Oscillometry System
The tremoFlo C-100 Airwave Oscillometry System is intended to measure respiratory system impedance using the Forced Oscillation Technique (FOT).
| Study group | Role | What they receive |
|---|---|---|
| Subjects with dyspnea referred for Cardiopulmonary Exercise Testing | Subjects with unexplained dyspnea referred for Cardiopulmonary Exercise Testing. Receives: Device: Oscillometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean respiratory system resistance and reactance
The oscillometer will collect an airway impedance measurement which is made up of multiple variables.
Measured: Single measurement, approximately day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2024
- Study start29 Oct 2024
- Primary completion1 May 2026
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breathing, MouthStudies of the same condition, open and under way.
- More trials run by University of RochesterThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 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
- NCT06554353
- Sponsor's protocol ID
- STUDY00009729
- Acronym
- COED
- Status last verified
- Oct 2025
- First submitted
- 12 Aug 2024
- Last updated
- 3 Jun 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 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiopulmonary Exercise Testing and Oscillometry for the Evaluation of Dyspnea
- ClinicalTrials.gov ID
- NCT06554353
- Acronym / sponsor ID
- COED / STUDY00009729
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- 29 Oct 2024 (actual)
- Primary completion
- 1 May 2026 (actual)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 15 Aug 2024 (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 determine if airway resistance to airflow and pressure, measured by Oscillometry, is associated with abnormal findings on Cardiopulmonary Exercise Testing in subjects who are experiencing shortness of breath.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects with dyspnea referred for Cardiopulmonary Exercise Testing | – | Device: OscillometerSubjects with unexplained dyspnea referred for Cardiopulmonary Exercise Testing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Up to fifty (50) human subjects will be recruited from the following University of Rochester locations: Mary Parkes Center for Asthma, Allergy, and Pulmonary Care, the Pulmonary Clinic at Strong Memorial Hospital, and The Pulmonary Clinic at Highland Hospital.
Key inclusion criteria (3 listed)
- Willingness to perform breathing test
- Must be able to speak and understand English
- Referred for Cardiopulmonary Exercise Testing
Key exclusion criteria (1 listed)
- Unable to provide consent or perform oscillometry test
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 |
|---|---|---|
| OscillometerAlso: THORASYS tremoFlo C-100 Airwave Oscillometry SystemThe tremoFlo C-100 Airwave Oscillometry System is intended to measure respiratory system impedance using the Forced Oscillation Technique (FOT). | Device | Subjects with dyspnea referred for Cardiopulmonary Exercise Testing |
Primary outcome
Mean respiratory system resistance and reactance
Time frame: Single measurement, approximately day 1
The oscillometer will collect an airway impedance measurement which is made up of multiple variables.
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 3 Jun 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, Mouth 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 3 inclusion and 1 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 3 Jun 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 (716-226-8429, 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?
Mean respiratory system resistance and reactance (time frame: Single measurement, approximately day 1). 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 3 Jun 2026.