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

Sponsor
University of Rochester (Other)
Overall Status
Recruiting
CT.gov ID
NCT05085795
Collaborator
(none)
50
1
9.3
5.4

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Device: Impulse Oscillometer

Study Design

Study Type:
Observational
Anticipated Enrollment :
50 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Impulse Oscillometry and the Bronchoprotective Effects of Deep Inspiration
Actual Study Start Date :
Oct 4, 2021
Anticipated Primary Completion Date :
Jul 15, 2022
Anticipated Study Completion Date :
Jul 15, 2022

Arms and Interventions

Arm 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
  • Outcome Measures

    Primary Outcome Measures

    1. Mean respiratory system impedance [pre deep inspiration, approximately day 1]

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

    2. Mean respiratory system resistance [post deep inspiration, approximately day 1]

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

    3. Mean change in respiratory system resistance [post and pre deep inspiration, approximately day 1]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mary Parkes Asthma and Allergy Center Rochester New York United States 14623

    Sponsors and Collaborators

    • University of Rochester

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Patrick Donohue, Co-Investigator, University of Rochester
    ClinicalTrials.gov Identifier:
    NCT05085795
    Other Study ID Numbers:
    • STUDY00006488
    First Posted:
    Oct 20, 2021
    Last Update Posted:
    Feb 11, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 11, 2022