Clincosm LogoSign in Get a demo

Evaluating the Use of a Device Called Impulse Oscillometry in Participants With Vocal Cord Disorders or Asthma

Sponsor
University of Rochester (Other)
Overall Status
Recruiting
CT.gov ID
NCT05246930
Collaborator
(none)
100
Enrollment
1
Location
6.9
Anticipated Duration (Months)
14.6
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

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

Study Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
The Study of Impulse Oscillometry in Inducible Laryngeal Obstruction
Actual Study Start Date :
Jun 15, 2022
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Jan 10, 2023

Arms and Interventions

Arm Intervention/Treatment
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.

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

    		•
    Subjects with diagnosis of asthma

    Subjects with physician-diagnosed asthma. Some subjects will have concomitant diagnosis of vocal cord dysfunction.

    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 [Single measurement, 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 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

    Exclusion Criteria:
    • Unable to provide consent or perform oscillometry test

    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:
    Steve Nicholas Georas, Professor, University of Rochester
    ClinicalTrials.gov Identifier:
    NCT05246930
    Other Study ID Numbers:
    • STUDY00006861
    First Posted:
    Feb 18, 2022
    Last Update Posted:
    Jul 8, 2022
    Last Verified:
    Jul 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:
    Asthma
    Vocal Cord Dysfunction
    Mouth Breathing

    Study Results

    No Results Posted as of Jul 8, 2022