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CompletedNCT05085795Updated Aug 15, 2023

Evaluating Deep Breathing in Health Participants Using a Device Called Impulse Oscillometry

An observational study in Breathing, Mouth and Lung Function Decreased, sponsored by University of Rochester. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-08-15.

Sponsored by University of Rochester · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
20
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Breathing, Mouth
  • Lung Function Decreased
03

In context

Respiratory Aspiration

1,092 studies on the registry are indexed under Respiratory Aspiration; 216 are open to participants now.

This study's enrollment of 20 is below the median of 65 across 184 observational studies indexed under Respiratory Aspiration.

Browse Respiratory Aspiration studies →

Lead sponsor

University of Rochester is the lead sponsor of 715 studies on the registry; 116 are open to participants now.

Of its 56 completed or terminated interventional studies of FDA-regulated products, 44 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

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

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Unable to or unwilling to provide consent, perform test, or provide basic demographic data
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
20 participants (actual)
Patient registry
No

Groups and cohorts

  • All participants

    Device: Impulse Oscillometer

Interventions

  • DeviceImpulse Oscillometer

    The tremoFlo C-100 Airwave Oscillometry System is intended to measure respiratory system impedance using the Forced Oscillation Technique (FOT).

    Also known as: THORASYS tremoFlo C-100 Airwave Oscillometry System

06

What researchers measure

Primary outcomes

  1. Mean respiratory system impedance

    The oscillometer will collect an airway impedance measurement which is made up of multiple variables.

    Time frame: pre deep inspiration, approximately day 1

  2. Mean respiratory system resistance

    The oscillometer will collect an airway impedance measurement which is made up of multiple variables.

    Time frame: post deep inspiration, approximately day 1

  3. Mean change in respiratory system resistance

    The oscillometer will collect an airway impedance measurement which is made up of multiple variables.

    Time frame: post and pre deep inspiration, approximately day 1

07

Study locations

1 site
  • Mary Parkes Asthma and Allergy Center
    Rochester, New York 14623, United States
08

References and documents

Study documents

  • Study protocol · Feb 14, 2022
  • Informed consent form · Feb 15, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 15, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05085795
Lead sponsor
University of Rochester
Responsible party
Steve Nicholas Georas (Professor, University of Rochester) — Principal investigator
First posted
Oct 20, 2021
Start date
Oct 4, 2021
Primary completion
May 27, 2022
Completion
Aug 8, 2023
Last update
Aug 15, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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