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

NCT ID: NCT05246930

Last Updated: 2024-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

43 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-06-15

Study Completion Date

2024-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Impulse Oscillometer

Intervention Type DEVICE

The tremoFlo C-100 Airwave Oscillometry System is intended to measure respiratory system impedance using the Forced Oscillation Technique (FOT).

Subjects with diagnosis of asthma

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

Impulse Oscillometer

Intervention Type DEVICE

The tremoFlo C-100 Airwave Oscillometry System is intended to measure respiratory system impedance using the Forced Oscillation Technique (FOT).

Interventions

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Impulse Oscillometer

The tremoFlo C-100 Airwave Oscillometry System is intended to measure respiratory system impedance using the Forced Oscillation Technique (FOT).

Intervention Type DEVICE

Other Intervention Names

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THORASYS tremoFlo C-100 Airwave Oscillometry System

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Rochester

OTHER

Sponsor Role lead

Responsible Party

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Steve Nicholas Georas

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Mary Parkes Asthma and Allergy Center

Rochester, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 39631550 (View on PubMed)

Other Identifiers

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STUDY00006861

Identifier Type: -

Identifier Source: org_study_id