Within-Breath Total Respiratory Input Impedance in Healthy Adult Subjects
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ClinicalTrials.gov Identifier: NCT04140825 |
Recruitment Status :
Recruiting
First Posted : October 28, 2019
Last Update Posted : January 14, 2021
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Assessment of lung function requires the evaluation of pulmonary function by spirometry. However, some patients (e.g. children, elderly, or diseased individuals) may have difficulty performing the related forced maximal respiratory maneuver correctly. Forced oscillation technique (FOT) is increasingly being used in clinical settings to evaluate lung function noninvasively by measuring the mechanical input impedance of the respiratory system. FOT measures lung impedance during tidal breathing, requiring minimal patient cooperation. Recently a new methodology (within breath analysis) has emerged to evaluate changes that occur in the impedance during the breathing activity. The within-breath calculation of impedance allows separating the contribution of inspiration and expiration to the measured parameters.
The purpose of this study is to establish reference ranges for within breath FOT parameters and their short term variability.
Condition or disease | Intervention/treatment |
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Respiratory Disease | Device: Resmon PRO FULL |
Purpose and rationale Assessment of lung function requires the evaluation of pulmonary function by spirometry. However, some patients (e.g. children, elderly, or diseased individuals) may have difficulty performing the related forced maximal respiratory maneuver correctly. Forced oscillation technique (FOT) is increasingly being used in clinical settings to evaluate lung function noninvasively by measuring the mechanical input impedance of the respiratory system. FOT measures lung impedance during tidal breathing, requiring minimal patient cooperation. Recently a new methodology (within breath analysis) has emerged to evaluate changes that occur in the impedance during the breathing activity. The within-breath calculation of impedance allows separating the contribution of inspiration and expiration to the measured parameters.
The purpose of this study is to establish reference ranges for within breath FOT parameters and their short term variability.
Objectives Primary: To derive equations to predict normal values and normality ranges for within-breath respiratory system resistance, reactance and related parameters at the selected stimulating waveform and to measure the short term variability of such parameters.
Secondary: To demonstrate the equivalence of the results of a single multiple-breath test to results obtained as an average of 3 consecutive repeated tests.
Study design This will be a prospective multi-center trial of healthy subjects. After signing the Informed Consent, an interview and physical examination will be performed. The examiner will confirm that subjects are able to perform acceptable and repeatable spirometry. FOT measurements will be performed, followed by standard spirometry measurements.
Study Duration This is a single visit study. Subject participation will be completed in 1 hour and 15 min. Enrollment of all subjects is expected to take 23 weeks (6 months).
Study Type : | Observational |
Estimated Enrollment : | 326 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Within-Breath Total Respiratory Input Impedance in Healthy Adult Subjects |
Actual Study Start Date : | October 18, 2018 |
Estimated Primary Completion Date : | December 31, 2021 |
Estimated Study Completion Date : | December 31, 2021 |
Group/Cohort | Intervention/treatment |
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Group 1
Subjects>=18 years old will measure as a minimum FOT and spirometry.
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Device: Resmon PRO FULL
Measurement of lung impedance by the Forced Oscillation Technique |
- Correlation between respiratory impedance parameters and the following variables: age, height, weight, sex, abdominal circumference and phenotype, breathing pattern parameters. [ Time Frame: 1 day ]The equation resulting from the multivariate regression analysis between impedance parameters assessed during the test and anthropometric measurements of age, height, weight, sex, abdominal circumference and phenotype, breathing pattern parameters
- Noninferiority of one FOT test vs. the average of three consecutive tests [ Time Frame: 1 day ]Noninferiority hypothesis of the results of a single test with multiple breaths free from artifacts compared to those obtained in the same session as an average or 3 consecutive repeated tests

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Probability Sample |
The following group will be considered:
Adults (>= 18 years old)
Inclusion Criteria:
- Subjects ≥ 18 years of age.
- Signature of the written informed consent
Exclusion Criteria:
Subjects will be excluded if they meet at least one of the following conditions:
- Abnormal spirometry defined as FEV1, FEV1/VC and VC below the LLN as established by the Global Lung function (GLI) 2012 reference equations.
- Smokers or ex-smokers
- BMI >30 kg/cm2
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History of respiratory symptoms using the ECRHS II screening questionnaire (www.ecrhs.org)
- Wheezing
- Cough
- Phlegm production
- Dyspnea
- Feeling of chest tightness
- Night awakening due to a cough attack
- Have a history of pulmonary or cardiac disease
- Had a recent (e.g., in the last 4 weeks) respiratory tract infection
- Have a neurological or neuromuscular disorder

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04140825
Contact: Alessandro Gobbi | +390236593690 | a.gobbi@restech.it | |
Contact: Pasquale Pompilio | +390236593690 | p.pompilio@restech.it |
United States, California | |
Biomedical Research Institute at Harbor- UCLA Medical Center | Recruiting |
Los Angeles, California, United States, 90502 | |
Contact: Janos Porszasz, MD porszasz@ucla.edu | |
United States, Vermont | |
University of Vermont Medical Center Inc. | Completed |
Burlington, Vermont, United States, 05401 | |
Italy | |
Catholic University of the Sacred Heart | Recruiting |
Rome, RM, Italy, 00100 | |
Contact: Leonello Fuso, MD leonello.fuso@policlinicogemelli.it | |
Contact: Chiara Contu, MD 3487398380 chiara.contu@policlinicogemelli.it | |
Ospedale Papa Giovanni XXIII | Recruiting |
Bergamo, Italy | |
Contact: Fabiano Di Marco | |
Principal Investigator: Fabiano Di Marco | |
Sub-Investigator: Gianluca Imeri | |
Spain | |
Hospital Clínic de Barcelona | Not yet recruiting |
Barcelona, Spain, 08036 | |
Contact: Felipe Burgos Ricon, MD FBURGOS@clinic.cat |
Principal Investigator: | Leonello Fuso, MD | Catholic University of the Sacred Heart | |
Principal Investigator: | David Kaminsky, MD | University of Vermont Medical Center Inc | |
Principal Investigator: | Janos Porszasz, MD | Biomedical Research Institute at Harbor- UCLA Medical Center | |
Principal Investigator: | Felip Burgos Rincón, MD | Hospital Clínic de Barcelona | |
Principal Investigator: | Fabiano Di Marco, MD | Ospedale Papa Giovanni XXIII |
Responsible Party: | Restech Srl |
ClinicalTrials.gov Identifier: | NCT04140825 |
Other Study ID Numbers: |
1/17 ADU |
First Posted: | October 28, 2019 Key Record Dates |
Last Update Posted: | January 14, 2021 |
Last Verified: | January 2021 |
Studies a U.S. FDA-regulated Device Product: | Yes |
Device Product Not Approved or Cleared by U.S. FDA: | Yes |
Respiration Disorders Respiratory Tract Diseases |