Body Composition Related Evaluation of Airway Tone and Hy... | NCT07356310

Studies
Body Composition Related Evaluation of Airway Tone and Hyper-rEactivity Using Oscillometry

NCT07356310

Sponsor

University of Rochester

Status

Recruiting

Last Update Posted

Apr 13, 2026Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Breathing
Lung Function Decreased
Asthma (Diagnosis)
Obesity

Interventions

Oscillometer

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 17, 2026Actual

Primary Completion Date

Jul 1, 2027Estimated

Completion Date

Nov 1, 2027Estimated

First Submitted Date

Jan 3, 2026

First Submission Date that Met QC Criteria

Jan 12, 2026

First Posted Date

Jan 21, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 7, 2026

Last Update Posted Date

Apr 13, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study will determine if airway resistance to airflow and pressure, measured by Oscillometry, is associated with abnormal findings on methacholine challenge testing and whether these findings are associated with body habitus,

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Subjects with dyspnea referred for methacholine challenge testing		Subjects with dyspnea being evaluated for asthma who are referred for methacholine challenge testing	Device: Oscillometer

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Oscillometer	Device	The tremoFlo C-100 Airwave Oscillometry System is intended to measure respiratory system impedance using the Forced Oscillation Technique (FOT).	Subjects with dyspnea referred for methacholine challenge testing

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Oscillometer	The oscillometer will collect an airway impedance measurement which is made up of multiple variables.	Single measurement, approximately day 1

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Willingness to perform breathing test
Must be able to speak and understand English
Referred for Methacholine Challenge Test

Exclusion Criteria:

Unable to provide consent or perform oscillometry test

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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 Pulmonary Clinic at Highland Hospital.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Patrick Donohue, MD	Contact	(585) 210-9301		patrick_donohue@urmc.rochester.edu

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Rochester Medical Center	Recruiting	Rochester	New York	14620	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D053120	Respiratory Aspiration
D012131	Respiratory Insufficiency
D001249	Asthma
D004194	Disease
D009765	Obesity

Ancestor Terms

ID	Term
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided