Breathing, MouthNCT05085795
Evaluating Deep Breathing in Health Participants Using a Device Called Impulse Oscillometry
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 resistance of the airway to airflow and pressure, measured by Impulse Oscillometry, is impacted by a deep breathe maneuver in a small cohort of healthy human subjects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breathing, Mouth, Lung Function Decreased
- What is being tested?
- Impulse Oscillometer
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Oct 2021to 8 Aug 2023
- 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 fifty (50) healthy subjects will be recruited from Mary Parkes Asthma and Allergy Center and the outpatient pulmonary clinics at the University of Rochester Medical Center, and from the Pulmonary and Critical Care Division at the University of Rochester
Who may be able to join
- Vaccinated against COVID-19
- Ability to provide informed consent
- Willingness to perform breathing test
- Willingness to provide basic demographic data
- Must be able to speak and understand English
Who cannot join
- Unable to or unwilling to provide consent, perform test, or provide basic demographic data
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: Impulse Oscillometry and the Bronchoprotective Effects of Deep Inspiration
This study will determine if resistance of the airway to airflow and pressure, measured by Impulse Oscillometry, is impacted by a deep breathe maneuver in a small cohort of healthy human subjects.
- Conditions
- Breathing, Mouth, Lung Function Decreased
- Being tested
- Impulse Oscillometer
- Medical subject headings
- Mouth Breathing, Respiratory Insufficiency
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 |
|---|---|---|
| All participants | Not described 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: pre deep inspiration, approximately day 1
Mean respiratory system resistance
The oscillometer will collect an airway impedance measurement which is made up of multiple variables.
Measured: post deep inspiration, approximately day 1
Mean change in respiratory system resistance
The oscillometer will collect an airway impedance measurement which is made up of multiple variables.
Measured: post and pre deep inspiration, 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 posted20 Oct 2021
- Study start4 Oct 2021
- Primary completion27 May 2022
- Study completion8 Aug 2023
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
- 20 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
- NCT05085795
- Sponsor's protocol ID
- STUDY00006488
- Status last verified
- Aug 2023
- First submitted
- 7 Oct 2021
- Last updated
- 15 Aug 2023
- 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 15 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impulse Oscillometry and the Bronchoprotective Effects of Deep Inspiration
- ClinicalTrials.gov ID
- NCT05085795
- Acronym / sponsor ID
- STUDY00006488
- Conditions
- Breathing, Mouth, Lung Function Decreased
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- 4 Oct 2021 (actual)
- Primary completion
- 27 May 2022 (actual)
- Study completion
- 8 Aug 2023 (actual)
- First posted
- 20 Oct 2021 (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 resistance of the airway to airflow and pressure, measured by Impulse Oscillometry, is impacted by a deep breathe maneuver in a small cohort of healthy human subjects.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All participants | – | Device: Impulse Oscillometer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Up to fifty (50) healthy subjects will be recruited from Mary Parkes Asthma and Allergy Center and the outpatient pulmonary clinics at the University of Rochester Medical Center, and from the Pulmonary and Critical Care Division at the University of Rochester
Key inclusion criteria (5 listed)
- Vaccinated against COVID-19
- Ability to provide informed consent
- Willingness to perform breathing test
- Willingness to provide basic demographic data
- Must be able to speak and understand English
Key exclusion criteria (1 listed)
- Unable to or unwilling to provide consent, perform test, or provide basic demographic data
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 | All participants |
Primary outcome
Mean respiratory system impedance
Time frame: pre deep inspiration, approximately day 1
The oscillometer will collect an airway impedance measurement which is made up of multiple variables.
Mean respiratory system resistance
Time frame: post deep inspiration, approximately day 1
The oscillometer will collect an airway impedance measurement which is made up of multiple variables.
Mean change in respiratory system resistance
Time frame: post and pre deep inspiration, 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 15 Aug 2023.
- Individual participant dataSharing planned: Undecided
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Asthma
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 5 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 15 Aug 2023. 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: pre deep inspiration, approximately day 1). The study lists 3 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 15 Aug 2023.