- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06554353
Cardiopulmonary Exercise Testing and Oscillometry for the Evaluation of Dyspnea (COED)
June 1, 2026 updated by: Patrick Donohue, University of Rochester
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 Overview
Status
Recruiting
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
50
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: PATRICK DONOHUE, MD
- Phone Number: 716-226-8429
- Email: patrick_donohue@urmc.rochester.edu
Study Locations
-
-
New York
-
Rochester, New York, United States, 14620
- Recruiting
- Highland Hospital
-
Contact:
- PATRICK A DONOHUE, MD
- Phone Number: 5853416774
- Email: patrick_donohue@urmc.rochester.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
N/A
Sampling Method
Non-Probability Sample
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.
Description
Inclusion Criteria:
- Willingness to perform breathing test
- Must be able to speak and understand English
- Referred for Cardiopulmonary Exercise Testing
Exclusion Criteria:
- Unable to provide consent or perform oscillometry test
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Subjects with dyspnea referred for Cardiopulmonary Exercise Testing
Subjects with unexplained dyspnea referred for Cardiopulmonary Exercise Testing.
|
The tremoFlo C-100 Airwave Oscillometry System is intended to measure respiratory system impedance using the Forced Oscillation Technique (FOT).
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Single measurement, approximately day 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 29, 2024
Primary Completion (Actual)
May 1, 2026
Study Completion (Estimated)
November 30, 2026
Study Registration Dates
First Submitted
August 12, 2024
First Submitted That Met QC Criteria
August 12, 2024
First Posted (Actual)
August 15, 2024
Study Record Updates
Last Update Posted (Actual)
June 3, 2026
Last Update Submitted That Met QC Criteria
June 1, 2026
Last Verified
October 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00009729
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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