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Respiratory DiseaseNCT04140825

Within-Breath Total Respiratory Input Impedance in Healthy Adult Subjects

An observational study of Respiratory Disease, run by Restech Srl at 4 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Respiratory Disease
What is being tested?
Resmon PRO FULL
Type of treatment
Medical device
How many people
231 participants
Where
4 sitesin 2 countries
Study dates
18 Oct 2018to 28 Jun 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: The following group will be considered: Adults (>= 18 years old)

Who may be able to join

  • Subjects ≥ 18 years of age.
  • Signature of the written informed consent

Who cannot join

  • 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
  • History of respiratory symptoms using the ECRHS II screening questionnaire (www.ecrhs.org)
  • Wheezing
Show all 14Show fewer
  • 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

Trial locations and contacts

4 sites in 2 countries.

4 sites in 2 countries

United States2 sites

  • University of Vermont Medical Center Inc.

    Burlington, Vermont, 05401

  • Biomedical Research Institute at Harbor- UCLA Medical Center

    Los Angeles, California, 90502

Other trials in United States

Italy2 sites

  • U.O.C. Malattie dell'apparato respiratorio e endoscopia delle vie aeree - Ospedale San Giovanni

    Roma, Rome, 00184

  • Catholic University of the Sacred Heart

    Rome, RM, 00100

Other trials in Italy

About this study

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.

Read the detailed description

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).

Being tested
Resmon PRO FULL
Medical subject headings
Respiration Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Resmon PRO FULLDevice

    Measurement of lung impedance by the Forced Oscillation Technique

Study groups in NCT04140825
Study groupRoleWhat they receive
Group 1Subjects>=18 years old will measure as a minimum FOT and spirometry.
Receives: Device: Resmon PRO FULL

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Correlation between respiratory impedance parameters and the following variables: age, height, weight, sex, abdominal circumference and phenotype, breathing pattern parameters.

    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

    Measured: 1 day

Secondary outcomes (1)

  1. Noninferiority of one FOT test vs. the average of three consecutive tests

    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

    Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Oct 2019
  2. Study start18 Oct 2018
  3. Primary completion28 Jun 2022
  4. Study completion28 Jun 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
231 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04140825
Sponsor's protocol ID
1/17 ADU
Status last verified
Jun 2022
First submitted
27 Jun 2019
Last updated
30 Jun 2022
Results posted
No
Data monitoring committee
No
FDA-regulated device
Yes

Publications

  • DUBOIS AB, BRODY AW, LEWIS DH, BURGESS BF Jr. Oscillation mechanics of lungs and chest in man. J Appl Physiol. 1956 May;8(6):587-94. doi: 10.1152/jappl.1956.8.6.587. No abstract available.

    PubMed 13331841

  • Peslin R, Ying Y, Gallina C, Duvivier C. Within-breath variations of forced oscillation resistance in healthy subjects. Eur Respir J. 1992 Jan;5(1):86-92.

    PubMed 1577156

  • Horowitz JG, Siegel SD, Primiano FP Jr, Chester EH. Computation of respiratory impedance from forced sinusoidal oscillations during breathing. Comput Biomed Res. 1983 Dec;16(6):499-521. doi: 10.1016/0010-4809(83)90037-x.

    PubMed 6653086

  • Dellaca RL, Santus P, Aliverti A, Stevenson N, Centanni S, Macklem PT, Pedotti A, Calverley PM. Detection of expiratory flow limitation in COPD using the forced oscillation technique. Eur Respir J. 2004 Feb;23(2):232-40. doi: 10.1183/09031936.04.00046804.

    PubMed 14979497

  • Dellaca RL, Pompilio PP, Walker PP, Duffy N, Pedotti A, Calverley PM. Effect of bronchodilation on expiratory flow limitation and resting lung mechanics in COPD. Eur Respir J. 2009 Jun;33(6):1329-37. doi: 10.1183/09031936.00139608. Epub 2009 Jan 22.

    PubMed 19164347

  • Pasker HG, Schepers R, Clement J, Van de Woestijne KP. Total respiratory impedance measured by means of the forced oscillation technique in subjects with and without respiratory complaints. Eur Respir J. 1996 Jan;9(1):131-9. doi: 10.1183/09031936.96.09010132.

    PubMed 8834346

  • Brown NJ, Xuan W, Salome CM, Berend N, Hunter ML, Musk AW, James AL, King GG. Reference equations for respiratory system resistance and reactance in adults. Respir Physiol Neurobiol. 2010 Jul 31;172(3):162-8. doi: 10.1016/j.resp.2010.05.013. Epub 2010 May 15.

    PubMed 20478414

  • Aarli BB, Eagan TM, Ellingsen I, Bakke PS, Hardie JA. Reference values for within-breath pulmonary impedance parameters in asymptomatic elderly. Clin Respir J. 2013 Jul;7(3):245-52. doi: 10.1111/j.1752-699X.2012.00312.x. Epub 2012 Aug 20.

    PubMed 22822726

  • Oostveen E, MacLeod D, Lorino H, Farre R, Hantos Z, Desager K, Marchal F; ERS Task Force on Respiratory Impedance Measurements. The forced oscillation technique in clinical practice: methodology, recommendations and future developments. Eur Respir J. 2003 Dec;22(6):1026-41. doi: 10.1183/09031936.03.00089403.

    PubMed 14680096

  • Quanjer PH, Stanojevic S, Cole TJ, Baur X, Hall GL, Culver BH, Enright PL, Hankinson JL, Ip MS, Zheng J, Stocks J; ERS Global Lung Function Initiative. Multi-ethnic reference values for spirometry for the 3-95-yr age range: the global lung function 2012 equations. Eur Respir J. 2012 Dec;40(6):1324-43. doi: 10.1183/09031936.00080312. Epub 2012 Jun 27.

    PubMed 22743675

  • Miller MR, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Crapo R, Enright P, van der Grinten CP, Gustafsson P, Jensen R, Johnson DC, MacIntyre N, McKay R, Navajas D, Pedersen OF, Pellegrino R, Viegi G, Wanger J; ATS/ERS Task Force. Standardisation of spirometry. Eur Respir J. 2005 Aug;26(2):319-38. doi: 10.1183/09031936.05.00034805. No abstract available.

    PubMed 16055882

  • Wanger J, Clausen JL, Coates A, Pedersen OF, Brusasco V, Burgos F, Casaburi R, Crapo R, Enright P, van der Grinten CP, Gustafsson P, Hankinson J, Jensen R, Johnson D, Macintyre N, McKay R, Miller MR, Navajas D, Pellegrino R, Viegi G. Standardisation of the measurement of lung volumes. Eur Respir J. 2005 Sep;26(3):511-22. doi: 10.1183/09031936.05.00035005. No abstract available.

    PubMed 16135736

  • Calogero C, Simpson SJ, Lombardi E, Parri N, Cuomo B, Palumbo M, de Martino M, Shackleton C, Verheggen M, Gavidia T, Franklin PJ, Kusel MM, Park J, Sly PD, Hall GL. Respiratory impedance and bronchodilator responsiveness in healthy children aged 2-13 years. Pediatr Pulmonol. 2013 Jul;48(7):707-15. doi: 10.1002/ppul.22699. Epub 2012 Nov 20.

    PubMed 23169525

  • Ducharme FM, Davis GM, Ducharme GR. Pediatric reference values for respiratory resistance measured by forced oscillation. Chest. 1998 May;113(5):1322-8. doi: 10.1378/chest.113.5.1322.

    PubMed 9596314

  • Oostveen E, Boda K, van der Grinten CP, James AL, Young S, Nieland H, Hantos Z. Respiratory impedance in healthy subjects: baseline values and bronchodilator response. Eur Respir J. 2013 Dec;42(6):1513-23. doi: 10.1183/09031936.00126212. Epub 2013 Apr 18.

    PubMed 23598954

Questions about this trial

What is this clinical trial studying?

An observational study of Respiratory Disease, run by Restech Srl at 4 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Correlation between respiratory impedance parameters and the following variables: age, height, weight, sex, abdominal circumference and phenotype, breathing pattern parameters. (time frame: 1 day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04140825, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2022.

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