NCT05085795

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 4, 2021

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

October 7, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 20, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 27, 2022

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 8, 2023

Completed
Last Updated

August 15, 2023

Status Verified

August 1, 2023

Enrollment Period

8 months

First QC Date

October 7, 2021

Last Update Submit

August 10, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (1)

All participants

Device: Impulse Oscillometer

Interventions

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
All participants

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Up to fifty (50) healthy subjects will be recruited from Mary Parkes Asthma and Allergy Center and the outpatient pulmonary clinics at the University of Rochester Medical Center, and from the Pulmonary and Critical Care Division at the University of Rochester

You may qualify if:

  • 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

You may not qualify if:

  • Unable to or unwilling to provide consent, perform test, or provide basic demographic data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mary Parkes Asthma and Allergy Center

Rochester, New York, 14623, United States

Location

MeSH Terms

Conditions

Mouth BreathingRespiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

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

October 7, 2021

First Posted

October 20, 2021

Study Start

October 4, 2021

Primary Completion

May 27, 2022

Study Completion

August 8, 2023

Last Updated

August 15, 2023

Record last verified: 2023-08

Locations