Breathing, MouthNCT05246930
Evaluating the Use of a Device Called Impulse Oscillometry in Participants With Vocal Cord Disorders or Asthma
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 Impulse Oscillometry, is impacted in subjects with vocal cord disorders and whether these measurements are different when compared to subjects with asthma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breathing, Mouth, Lung Function Decreased, Vocal Cord Dysfunction
- What is being tested?
- Impulse Oscillometer
- Type of treatment
- Medical device
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2022to 1 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 one hundred (100) 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 Voice Center, an Otolaryngology Clinic at Clinton Woods.
Who may be able to join
- Vaccinated against COVID-19 or testing negative for COVID-19 by viral PCT within 5 days before testing
- Willingness to perform breathing test
- Must be able to speak and understand English
- Documented diagnosis of asthma, documented clinical diagnosis of vocal cord dysfunction, or undergoing evaluation for vocal cord dysfunction
Who cannot join
- Unable to provide consent or perform oscillometry test
Trial locations and contacts
1 site in 1 country.
United States1 site
Mary Parkes Asthma and Allergy Center
Rochester, New York, 14623
About this study
Official title: The Study of Impulse Oscillometry in Inducible Laryngeal Obstruction
This study will determine if airway resistance to airflow and pressure, measured by Impulse Oscillometry, is impacted in subjects with vocal cord disorders and whether these measurements are different when compared to subjects with asthma.
- Conditions
- Breathing, Mouth, Lung Function Decreased, Vocal Cord Dysfunction, Laryngeal Obstruction, Asthma
- Being tested
- Impulse Oscillometer
- Medical subject headings
- Mouth Breathing, Respiratory Insufficiency, Vocal Cord Dysfunction, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Impulse 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 a diagnosis of vocal cord dysfunction | Subjects with a confirmed or suspected diagnosis of vocal cord dysfunction (also called inducible laryngeal obstruction). Some subjects will have concomitant diagnosis of asthma. Receives: Device: Impulse Oscillometer | |
| Subjects with diagnosis of asthma | Subjects with physician-diagnosed asthma. Some subjects will have concomitant diagnosis of vocal cord dysfunction. Receives: Device: Impulse Oscillometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean respiratory system impedance
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 posted18 Feb 2022
- Study start15 Jun 2022
- Primary completion1 Jun 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breathing, MouthStudies 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
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steve Nicholas Georas, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05246930
- Sponsor's protocol ID
- STUDY00006861
- Status last verified
- Dec 2024
- First submitted
- 8 Feb 2022
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Donohue P, Connolly M, D'Alfonso M, Jackson G, Grasso LC, Cai X, O'Connell Ferster AP, Schneider GT, Khurana S, Georas SN. Peripheral airways dysfunction measured by oscillometry differentiates asthma from inducible laryngeal obstruction. Respir Med. 2025 Jan;236:107905. doi: 10.1016/j.rmed.2024.107905. Epub 2024 Dec 3.
PubMed 39631550
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study of Impulse Oscillometry in Inducible Laryngeal Obstruction
- ClinicalTrials.gov ID
- NCT05246930
- Acronym / sponsor ID
- STUDY00006861
- Conditions
- Breathing, Mouth, Lung Function Decreased, Vocal Cord Dysfunction, Laryngeal Obstruction, Asthma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- 15 Jun 2022 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 18 Feb 2022 (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 Impulse Oscillometry, is impacted in subjects with vocal cord disorders and whether these measurements are different when compared to subjects with asthma.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subjects with a diagnosis of vocal cord dysfunction | – | Device: Impulse OscillometerSubjects with a confirmed or suspected diagnosis of vocal cord dysfunction (also called inducible laryngeal obstruction). Some subjects will have concomitant diagnosis of asthma. |
| Subjects with diagnosis of asthma | – | Device: Impulse OscillometerSubjects with physician-diagnosed asthma. Some subjects will have concomitant diagnosis of vocal cord dysfunction. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Up to one hundred (100) 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 Voice Center, an Otolaryngology Clinic at Clinton Woods.
Key inclusion criteria (4 listed)
- Vaccinated against COVID-19 or testing negative for COVID-19 by viral PCT within 5 days before testing
- Willingness to perform breathing test
- Must be able to speak and understand English
- Documented diagnosis of asthma, documented clinical diagnosis of vocal cord dysfunction, or undergoing evaluation for vocal cord dysfunction
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 |
|---|---|---|
| Impulse 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 a diagnosis of vocal cord dysfunction, Subjects with diagnosis of asthma |
Primary outcome
Mean respiratory system impedance
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
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
- Derived from this study: PubMed 39631550Donohue P, Connolly M, D'Alfonso M, Jackson G, Grasso LC, Cai X, O'Connell Ferster AP, Schneider GT, Khurana S, Georas SN. Peripheral airways dysfunction measured by oscillometry differentiates asthma from inducible laryngeal obstruction. Respir Med. 2025 Jan;236:107905. doi: 10.1016/j.rmed.2024.107905. Epub 2024 Dec 3.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 4 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: finished, as of the sponsor's last update on 18 Dec 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean respiratory system impedance (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?
On the ClinicalTrials.gov record for NCT05246930, which also lists 1 linked publication.
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 18 Dec 2024.