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

The Study of Impulse Oscillometry in Inducible Laryngeal Obstruction

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.

Study Overview

• Status: Recruiting
• Conditions: Asthma; Vocal Cord Dysfunction; Lung Function Decreased; Breathing, Mouth; Laryngeal Obstruction
• Intervention / Treatment: Device: Impulse Oscillometer

• Study Type: Observational
• Enrollment (Estimated): 100

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
      • Recruiting
      • Mary Parkes Asthma and Allergy Center
      • Contact: Patrick Donohue, MD; Phone Number: 716-226-8429; Email: patrick_donohue@urmc.rochester.edu

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 one hundred (100) human subjects will be recruited from the following University of Rochester locations: Mary Parkes Center for Asthma, Allergy, and Pulmonary Care, the Pulmonary Clinic at Strong Memorial Hospital, and The Voice Center, an Otolaryngology Clinic at Clinton Woods.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

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.	Single measurement, approximately day 1

Collaborators and Investigators

• Sponsor: University of Rochester

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2022
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: February 8, 2022
• First Submitted That Met QC Criteria: February 8, 2022
• First Posted (Actual): February 18, 2022

Study Record Updates

• Last Update Posted (Actual): November 28, 2023
• Last Update Submitted That Met QC Criteria: November 27, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Respiration Disorders; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Otorhinolaryngologic Diseases; Signs and Symptoms, Respiratory; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Laryngeal Diseases; Asthma; Vocal Cord Dysfunction; Mouth Breathing
• Other Study ID Numbers: STUDY00006861

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