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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05085795
Other study ID # STUDY00006488
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 4, 2021
Est. completion date August 8, 2023

Study information

Verified date August 2023
Source University of Rochester
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study will determine if resistance of the airway to airflow and pressure, measured by Impulse Oscillometry, is impacted by a deep breathe maneuver in a small cohort of healthy human subjects.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date August 8, 2023
Est. primary completion date May 27, 2022
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Vaccinated against COVID-19 - Ability to provide informed consent - Willingness to perform breathing test - Willingness to provide basic demographic data - Must be able to speak and understand English Exclusion Criteria: - Unable to or unwilling to provide consent, perform test, or provide basic demographic data

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. pre deep inspiration, approximately day 1
Primary Mean respiratory system resistance The oscillometer will collect an airway impedance measurement which is made up of multiple variables. post deep inspiration, approximately day 1
Primary Mean change in respiratory system resistance The oscillometer will collect an airway impedance measurement which is made up of multiple variables. post and pre deep inspiration, approximately day 1
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