NCT07614685

Brief Summary

This study will examine the relationship of airways resistance measured by oscillometry with ventilation defects measured by Phase Resolved Functional Lung (PREFUL) MRI in healthy human subjects.

Trial Health

63
Monitor

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
18mo left

Started Jul 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 20, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 29, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2026

Expected
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2028

Last Updated

May 29, 2026

Status Verified

May 1, 2026

Enrollment Period

1 year

First QC Date

May 20, 2026

Last Update Submit

May 20, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Oscillometer

    The oscillometer will collect an airway impedance measurement which is made up of multiple variables.

    Single measurement, approximately 1 day

  • Phase Resolved Functional Lung (PREFUL) MRI

    PREFUL MRI will acquire images of the lungs and a measurement called the ventilatory defect percentage (or VDP) will be calculated.

    Single measurement, approximately 1 day

Study Arms (1)

All participants

Device: Airway OscillometerDiagnostic Test: Phase Resolved Functional Lung MRI

Interventions

The termoflo c-100 Airwave Oscillometer System is intended to measure respiratory system impedance using the Forced Oscillation Technique (FOT).

All participants

The Phase Resolved Functional Lung (PREFUL) MRI technique acquires images of the lung so that measures of ventilatory defect percentage can be calculated.

All participants

Eligibility Criteria

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

Up to twenty (20) healthy human subjects will be recruited from the outpatient clinics at the University of Rochester Medical Center and the Mary Parkes Asthma Center.

You may qualify if:

  • Age 18 years or older
  • Ability to provide consent
  • Willingness to perform MRI and breathing test
  • Must be able to speak and understand English

You may not qualify if:

  • Pregnant
  • Unable or willing to provide consent or perform the required maneuvers for testing.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Respiratory AspirationRespiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 20, 2026

First Posted

May 29, 2026

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

January 1, 2028

Last Updated

May 29, 2026

Record last verified: 2026-05

Locations