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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05246930
Other study ID # STUDY00006861
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 15, 2022
Est. completion date December 1, 2024

Study information

Verified date November 2023
Source University of Rochester
Contact Patrick Donohue, MD
Phone 716-226-8429
Email patrick_donohue@urmc.rochester.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date December 1, 2024
Est. primary completion date June 1, 2024
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

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

Locations

Country Name City State
United States Mary Parkes Asthma and Allergy Center Rochester New York

Sponsors (1)

Lead Sponsor Collaborator
University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mean respiratory system impedance The oscillometer will collect an airway impedance measurement which is made up of multiple variables. Single measurement, approximately day 1
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