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

NCT05246930 | Completed FDA Device

• 1 other identifier: STUDY00006861
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Breathing, Mouth; Lung Function Decreased; Vocal Cord Dysfunction; Laryngeal Obstruction; Asthma

Outcome Measures

Primary Outcomes (1)

• Mean respiratory system impedance

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

  Single measurement, approximately day 1

Study Arms (2)

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

Subjects with diagnosis of asthma

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

Device: Impulse Oscillometer

Interventions

Impulse Oscillometer DEVICE

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

Subjects with a diagnosis of vocal cord dysfunction; Subjects with diagnosis of asthma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Unable to provide consent or perform oscillometry test

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

Mary Parkes Asthma and Allergy Center

Rochester, New York, 14623, United States

Location

Related Publications (1)

• Donohue P, Connolly M, D'Alfonso M, Jackson G, Grasso LC, Cai X, O'Connell Ferster AP, Schneider GT, Khurana S, Georas SN. Peripheral airways dysfunction measured by oscillometry differentiates asthma from inducible laryngeal obstruction. Respir Med. 2025 Jan;236:107905. doi: 10.1016/j.rmed.2024.107905. Epub 2024 Dec 3.

  PMID: 39631550 DERIVED

MeSH Terms

Conditions

Mouth Breathing; Respiratory Insufficiency; Vocal Cord Dysfunction; Asthma

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Laryngeal Diseases; Otorhinolaryngologic Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 8, 2022
• First Posted: February 18, 2022
• Study Start: June 15, 2022
• Primary Completion: June 1, 2024
• Study Completion: December 1, 2024
• Last Updated: December 18, 2024

Record last verified: 2024-12

Locations

US (1)