HealthyOSCILLONiCA-PLNCT07207720
Respiratory Oscillometry Norms for Polish Children and Adolescent.
An observational study of Healthy and Pulmonary Function Test, run by Medical University of Gdansk at 1 site in Poland.
Trial summary
This study aims to establish normative values for respiratory oscillometry in the Polish pediatric population. It is designed as a multicentre, population-based, prospective cohort study including children and adolescents aged 3-18 years. Read more about this study
- Who is it for?
- Ages 3 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Pulmonary Function Test
- How many people
- 2,000 participants
- Where
- 1 sitePoland
- Study dates
- 10 Jan 2023to 30 Jul 2025
- 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 3 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Healthy Polish children and adolescents aged 3 to 18 years. Participants are recruited from schools, kindergartens, and pediatric outpatient clinics across 12 centers in Poland. Only individuals without chronic respiratory diseases or recent respiratory infections are eligible.
Inclusion Criteria:1. Age between 3 and 18 years. 2. Caucasian race (Born and residing in Poland). 3. Absence of chronic respiratory disease or acute respiratory symptoms at the time of testing.
- Written informed consent from a parent/legal guardian (for participants <16 years) or from the participant if ≥16 years.
-
Exclusion Criteria:1. History of chronic lung disease (e.g., asthma, cystic fibrosis, bronchopulmonary dysplasia, interstitial lung disease).
- Acute respiratory infection within 4 weeks before testing. 3. Severe chronic comorbidities (e.g., congenital heart disease, neuromuscular disorders).
- Chest deformation 5. Inability to perform oscillometry according to ERS standards.
-
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Respiratory Oscillometry - Establishing Reference Values in Polish Children and Adolescents Aged 3-18 Years (OSCILLONiCA-PL-Kids)
This study aims to establish normative values for respiratory oscillometry in the Polish pediatric population. It is designed as a multicentre, population-based, prospective cohort study including children and adolescents aged 3-18 years. The results will provide reference standards for respiratory oscillometry that may support the diagnosis and monitoring of respiratory diseases in clinical practice and research.
Read the detailed description
OSCILLONiCA-PL-Kids is a multicentre, observational, cross-sectional study designed to establish normative reference values for respiratory oscillometry (IOS) in healthy Polish children and adolescents aged 3-18 years. The study is coordinated by the Polish Society of Pediatric Pulmonology and conducted in 12 pediatric centers across Poland between 2023 and 2025.
Standardized Jaeger oscillometry systems (ERS-validated) are used across all sites, following harmonized operating procedures. All investigators and technicians undergo centralized training and certification, with periodic audits and refresher sessions to ensure procedural consistency and data quality. Measurements are performed during tidal breathing with cheek support and a nose clip, recording at least three technically acceptable trials per participant. Parameters include resistance (Rrs) and reactance (Xrs) at 5, 10, and 20 Hz, resonance frequency (Fres), and area of reactance (AX).
Anthropometric data (height, weight, age, sex) are collected simultaneously to allow modeling of predicted values. Data integrity is verified using automated quality-control algorithms. Reference equations for oscillometric parameters will be derived using generalized additive models for location, scale, and shape (GAMLSS, LMS method). Model performance will be evaluated using the Schwarz Bayesian Criterion, with sensitivity analyses assessing robustness to borderline cases and environmental exposures.
Raw measurement data, as well as derived parameters (means, standard deviations, percentiles, and z-scores), will be used to generate normative reference values and percentile charts stratified by age, height, and sex.
Quality assurance: Data collection and management follow standardized operating procedures (SOPs) approved by the coordinating center. Each site conducts internal data validation prior to upload, and periodic cross-site audits are performed to ensure compliance and consistency. Automatic range and logic checks are implemented in the database to flag out-of-range or inconsistent entries.
Missing data plan: Incomplete or invalid recordings will be excluded from normative modeling. Sensitivity analyses will evaluate the impact of missing data on reference equations. Imputation will not be used for normative dataset derivation.
The study adheres to ERS Technical Standards for Oscillometry (2020) and complies with Good Clinical Practice for observational research. The resulting reference equations and percentile charts will provide validated normative standards for pediatric oscillometry in Poland and support future international harmonization efforts.
- Conditions
- Healthy, Pulmonary Function Test
- Keywords
- Reference Values, Oscillometry, Impulse Oscillometry, Respiratory Mechanics, Children, Adolescents, Poland, pulmonary function test
What is being measured
The primary outcome is the main question the study is designed to answer.
Reference values and z-score distributions for respiratory oscillometry parameters (Rrs, Xrs, Fres, AX) in healthy Polish children and adolescents
Quantitative reference data for respiratory oscillometry parameters - respiratory resistance (Rrs) and reactance (Xrs) at 5, 10, and 20 Hz, resonance frequency (Fres), and area of reactance (AX) - measured using impulse oscillometry (IOS) in healthy children and adolescents aged 3-18 years.
Results will be summarized as mean (Units of Measure:
Rrs, Xrs: kPa·s·L-¹; Fres: Hz; AX: kPa·L-¹); standard deviation (SD), percentiles, and z-score distributions stratified by age, height, and sex.
Measured: Single assessment at baseline (during one study visit).
Secondary outcomes (6)
Prediction equations and z-score reference models for oscillometric parameters (Rrs, Xrs, Fres, AX)
Regression models describing the relationship between oscillometric parameters (Rrs, Xrs, Fres, AX) and anthropometric predictors (age, height, weight, sex). Models will be developed using the Generalized Additive Models for Location, Scale, and Shape (GAMLSS; LMS method).
Predicted means, SDs, and z-score equations will be reported, together with model coefficients, standard errors, and model fit indices (Schwarz Bayesian Criterion). Units of Measure: Model coefficients (unitless); Rrs, Xrs: kPa·s·L-¹; Fres: Hz; AX: kPa·L-¹; z-scores: dimensionless
Measured: At baseline (single study visit).
Variability of respiratory oscillometry parameters (Rrs, Xrs, Fres, AX) across pediatric age groups
Mean and standard deviation of oscillometry parameters - respiratory resistance (Rrs, kPa·s·L-¹), reactance (Xrs, kPa·s·L-¹), resonance frequency (Fres, Hz), and area of reactance (AX, kPa·L-¹) - compared across three predefined pediatric age groups: preschool (3-5 years), school-aged (6-12 years), and adolescents (13-18 years).
All parameters will also be expressed as z-scores (dimensionless) for standardized inter-group comparison.Units of Measure: Rrs, Xrs: kPa·s·L-¹; Fres: Hz; AX: kPa·L-¹; z-scores: dimensionless.
Measured: At baseline (single study visit).
Z-score distributions for oscillometry parameters across Polish and international pediatric cohorts
Z-score distributions for respiratory resistance (Rrs), reactance (Xrs), resonance frequency (Fres), and area of reactance (AX) derived from the OSCILLONiCA-KIDS dataset and published international reference datasets (Austria).
Differences between cohorts will be summarized as mean z-score differences and limits of agreement.
Measured: Up to 24 months after completion of data collection (estimated by December 2026).
Nomograms and percentile charts for clinical use
Nomograms and percentile charts illustrating predicted oscillometry parameters (Rrs, Xrs, Fres, AX) across age, height, and sex categories will be created to support clinical interpretation. Each chart will include mean, standard deviation (SD), percentiles (5th, 25th, 50th, 75th, 95th), and corresponding z-score ranges.Units of Measure: Rrs, Xrs: kPa·s·L-¹; Fres: Hz; AX: kPa·L-¹; z-scores: dimensionless
Measured: Through study completion, approximately 36 months after study start (January 2023 - December 2025).
De-identified reference dataset of pediatric oscillometry measurements
A de-identified dataset containing oscillometry and anthropometric data (age, height, weight, sex, Rrs, Xrs, Fres, AX) will be compiled for research use and potential integration into international reference initiatives (e.g., Global Lung Function Initiative). Dataset records will be reported as counts of included participants and data completeness metrics. Units of Measure: Number of data records (n); data completeness (%)
Measured: Through study completion, approximately 36 months after study start (January 2023 - December 2025).
Quality and performance indicators of school-based oscillometry testing
Proportion of technically acceptable recordings, coefficient of variation (CoV) between repeated trials, and proportion of children successfully completing valid measurements during school-based testing sessions. Units of Measure:
Percentage of valid recordings (%); coefficient of variation (%)
Measured: Throughout data collection, approximately January 2023 - June 2025.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2025
- Study start10 Jan 2023
- Primary completion30 Jul 2025
- Study completion30 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Medical University of GdanskThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 2,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Gdansk
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eliza Wasilewska, Medical University of Gdansk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07207720
- Sponsor's protocol ID
- OSCILLONiCA-PL-Kids 01/2023
- Acronym
- OSCILLONiCA-PL
- Status last verified
- Oct 2025
- First submitted
- 22 Sep 2025
- Last updated
- 6 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The study team will consider sharing de-identified individual participant data after publication of the primary results, depending on institutional policies and ethical approval.
Publications
Kaminsky DA, Simpson SJ, Berger KI, Calverley P, de Melo PL, Dandurand R, Dellaca RL, Farah CS, Farre R, Hall GL, Ioan I, Irvin CG, Kaczka DW, King GG, Kurosawa H, Lombardi E, Maksym GN, Marchal F, Oostveen E, Oppenheimer BW, Robinson PD, van den Berge M, Thamrin C. Clinical significance and applications of oscillometry. Eur Respir Rev. 2022 Feb 9;31(163):210208. doi: 10.1183/16000617.0208-2021. Print 2022 Mar 31.
PubMed 35140105King GG, Bates J, Berger KI, Calverley P, de Melo PL, Dellaca RL, Farre R, Hall GL, Ioan I, Irvin CG, Kaczka DW, Kaminsky DA, Kurosawa H, Lombardi E, Maksym GN, Marchal F, Oppenheimer BW, Simpson SJ, Thamrin C, van den Berge M, Oostveen E. Technical standards for respiratory oscillometry. Eur Respir J. 2020 Feb 27;55(2):1900753. doi: 10.1183/13993003.00753-2019. Print 2020 Feb.
PubMed 31772002Desai U, Joshi JM. Impulse oscillometry. Adv Respir Med. 2019;87(4):235-238. doi: 10.5603/ARM.a2019.0039.
PubMed 31476011de Oliveira Jorge PP, de Lima JHP, Chong E Silva DC, Medeiros D, Sole D, Wandalsen GF. Impulse oscillometry in the assessment of children's lung function. Allergol Immunopathol (Madr). 2019 May-Jun;47(3):295-302. doi: 10.1016/j.aller.2018.03.003. Epub 2018 Jul 5.
PubMed 29983239Wasilewska E, Radlinski J, Minarowska A, Peradzynska J, Walicka-Serzysko K, Krenke K, Doniec Z, Mazurek H, Dmenska H, Polomska J, Sikorska-Szaflik H, Wojsyk-Banaszak I. Respiratory oscillometry reference values in Polish children and adolescents: a nationwide multicenter cross-sectional study (OSCILLONiCA-PL-Kids) - Study Protocol. Adv Med Sci. 2026 Sep 9:S1896-1126(26)00036-2. doi: 10.1016/j.advms.2026.09.002. Online ahead of print.
PubMed 42716378
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Oscillometry - Establishing Reference Values in Polish Children and Adolescents Aged 3-18 Years (OSCILLONiCA-PL-Kids)
- ClinicalTrials.gov ID
- NCT07207720
- Acronym / sponsor ID
- OSCILLONiCA-PL / OSCILLONiCA-PL-Kids 01/2023
- Conditions
- Healthy, Pulmonary Function Test
- Keywords
- Reference Values, Oscillometry, Impulse Oscillometry, Respiratory Mechanics, Children, Adolescents, Poland, pulmonary function test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- Medical University of GdanskUniversity, hospital or other
- Study start
- 10 Jan 2023 (actual)
- Primary completion
- 30 Jul 2025 (actual)
- Study completion
- 30 Jul 2025 (actual)
- First posted
- 6 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to establish normative values for respiratory oscillometry in the Polish pediatric population. It is designed as a multicentre, population-based, prospective cohort study including children and adolescents aged 3-18 years. The results will provide reference standards for respiratory oscillometry that may support the diagnosis and monitoring of respiratory diseases in clinical practice and research.
Detailed description
OSCILLONiCA-PL-Kids is a multicentre, observational, cross-sectional study designed to establish normative reference values for respiratory oscillometry (IOS) in healthy Polish children and adolescents aged 3-18 years. The study is coordinated by the Polish Society of Pediatric Pulmonology and conducted in 12 pediatric centers across Poland between 2023 and 2025.
Standardized Jaeger oscillometry systems (ERS-validated) are used across all sites, following harmonized operating procedures. All investigators and technicians undergo centralized training and certification, with periodic audits and refresher sessions to ensure procedural consistency and data quality. Measurements are performed during tidal breathing with cheek support and a nose clip, recording at least three technically acceptable trials per participant. Parameters include resistance (Rrs) and reactance (Xrs) at 5, 10, and 20 Hz, resonance frequency (Fres), and area of reactance (AX).
Anthropometric data (height, weight, age, sex) are collected simultaneously to allow modeling of predicted values. Data integrity is verified using automated quality-control algorithms. Reference equations for oscillometric parameters will be derived using generalized additive models for location, scale, and shape (GAMLSS, LMS method). Model performance will be evaluated using the Schwarz Bayesian Criterion, with sensitivity analyses assessing robustness to borderline cases and environmental exposures.
Raw measurement data, as well as derived parameters (means, standard deviations, percentiles, and z-scores), will be used to generate normative reference values and percentile charts stratified by age, height, and sex.
Quality assurance: Data collection and management follow standardized operating procedures (SOPs) approved by the coordinating center. Each site conducts internal data validation prior to upload, and periodic cross-site audits are performed to ensure compliance and consistency. Automatic range and logic checks are implemented in the database to flag out-of-range or inconsistent entries.
Missing data plan: Incomplete or invalid recordings will be excluded from normative modeling. Sensitivity analyses will evaluate the impact of missing data on reference equations. Imputation will not be used for normative dataset derivation.
The study adheres to ERS Technical Standards for Oscillometry (2020) and complies with Good Clinical Practice for observational research. The resulting reference equations and percentile charts will provide validated normative standards for pediatric oscillometry in Poland and support future international harmonization efforts.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Healthy Polish children and adolescents aged 3 to 18 years. Participants are recruited from schools, kindergartens, and pediatric outpatient clinics across 12 centers in Poland. Only individuals without chronic respiratory diseases or recent respiratory infections are eligible.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Reference values and z-score distributions for respiratory oscillometry parameters (Rrs, Xrs, Fres, AX) in healthy Polish children and adolescents
Time frame: Single assessment at baseline (during one study visit).
Quantitative reference data for respiratory oscillometry parameters - respiratory resistance (Rrs) and reactance (Xrs) at 5, 10, and 20 Hz, resonance frequency (Fres), and area of reactance (AX) - measured using impulse oscillometry (IOS) in healthy children and adolescents aged 3-18 years. Results will be summarized as mean (Units of Measure: Rrs, Xrs: kPa·s·L-¹; Fres: Hz; AX: kPa·L-¹); standard deviation (SD), percentiles, and z-score distributions stratified by age, height, and sex.
6 secondary outcomes
Prediction equations and z-score reference models for oscillometric parameters (Rrs, Xrs, Fres, AX)
Time frame: At baseline (single study visit).
Variability of respiratory oscillometry parameters (Rrs, Xrs, Fres, AX) across pediatric age groups
Time frame: At baseline (single study visit).
Z-score distributions for oscillometry parameters across Polish and international pediatric cohorts
Time frame: Up to 24 months after completion of data collection (estimated by December 2026).
Nomograms and percentile charts for clinical use
Time frame: Through study completion, approximately 36 months after study start (January 2023 - December 2025).
De-identified reference dataset of pediatric oscillometry measurements
Time frame: Through study completion, approximately 36 months after study start (January 2023 - December 2025).
Quality and performance indicators of school-based oscillometry testing
Time frame: Throughout data collection, approximately January 2023 - June 2025.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2025.
- Background: PubMed 35140105Kaminsky DA, Simpson SJ, Berger KI, Calverley P, de Melo PL, Dandurand R, Dellaca RL, Farah CS, Farre R, Hall GL, Ioan I, Irvin CG, Kaczka DW, King GG, Kurosawa H, Lombardi E, Maksym GN, Marchal F, Oostveen E, Oppenheimer BW, Robinson PD, van den Berge M, Thamrin C. Clinical significance and applications of oscillometry. Eur Respir Rev. 2022 Feb 9;31(163):210208. doi: 10.1183/16000617.0208-2021. Print 2022 Mar 31.
- Background: PubMed 31772002King GG, Bates J, Berger KI, Calverley P, de Melo PL, Dellaca RL, Farre R, Hall GL, Ioan I, Irvin CG, Kaczka DW, Kaminsky DA, Kurosawa H, Lombardi E, Maksym GN, Marchal F, Oppenheimer BW, Simpson SJ, Thamrin C, van den Berge M, Oostveen E. Technical standards for respiratory oscillometry. Eur Respir J. 2020 Feb 27;55(2):1900753. doi: 10.1183/13993003.00753-2019. Print 2020 Feb.
- Background: PubMed 31476011Desai U, Joshi JM. Impulse oscillometry. Adv Respir Med. 2019;87(4):235-238. doi: 10.5603/ARM.a2019.0039.
- Background: PubMed 29983239de Oliveira Jorge PP, de Lima JHP, Chong E Silva DC, Medeiros D, Sole D, Wandalsen GF. Impulse oscillometry in the assessment of children's lung function. Allergol Immunopathol (Madr). 2019 May-Jun;47(3):295-302. doi: 10.1016/j.aller.2018.03.003. Epub 2018 Jul 5.
- Derived from this study: PubMed 42716378Wasilewska E, Radlinski J, Minarowska A, Peradzynska J, Walicka-Serzysko K, Krenke K, Doniec Z, Mazurek H, Dmenska H, Polomska J, Sikorska-Szaflik H, Wojsyk-Banaszak I. Respiratory oscillometry reference values in Polish children and adolescents: a nationwide multicenter cross-sectional study (OSCILLONiCA-PL-Kids) - Study Protocol. Adv Med Sci. 2026 Sep 9:S1896-1126(26)00036-2. doi: 10.1016/j.advms.2026.09.002. Online ahead of print.
- This external link directs to the official website of the Polish Society of Pediatric Pulmonology (PTPD), which provides information about the OSCILLONiCA-PL Kids study. The page contains a public description of the project "Respiratory Oscillometry - EsLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. The study team will consider sharing de-identified individual participant data after publication of the primary results, depending on institutional policies and ethical approval.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy and Pulmonary Function Test, run by Medical University of Gdansk at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 6 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. 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?
Reference values and z-score distributions for respiratory oscillometry parameters (Rrs, Xrs, Fres, AX) in healthy Polish children and adolescents (time frame: Single assessment at baseline (during one study visit).). 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 NCT07207720, which also lists 5 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 6 Oct 2025.