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

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.

Study Overview

• Status: Completed
• Conditions: Lung Function Decreased; Breathing, Mouth
• Intervention / Treatment: Device: Impulse Oscillometer

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

• Study Contact: Name: Patrick Donohue, MD; Phone Number: 716-226-8429; Email: patrick_donohue@urmc.rochester.edu

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• 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

Description

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:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
All participants	Device: Impulse Oscillometer; The tremoFlo C-100 Airwave Oscillometry System is intended to measure respiratory system impedance using the Forced Oscillation Technique (FOT).; Other Names: THORASYS tremoFlo C-100 Airwave Oscillometry System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean respiratory system impedance	The oscillometer will collect an airway impedance measurement which is made up of multiple variables.	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.	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.	post and pre deep inspiration, approximately day 1

Collaborators and Investigators

• Sponsor: University of Rochester

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2021
• Primary Completion (Actual): May 27, 2022
• Study Completion (Actual): August 8, 2023

Study Registration Dates

• First Submitted: October 7, 2021
• First Submitted That Met QC Criteria: October 7, 2021
• First Posted (Actual): October 20, 2021

Study Record Updates

• Last Update Posted (Actual): August 15, 2023
• Last Update Submitted That Met QC Criteria: August 10, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Respiratory Aspiration; Mouth Breathing
• Other Study ID Numbers: STUDY00006488

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