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Time Course of Respiratory Oscillometry Parameters During Nasal High-Flow Therapy in Stable Chronic Obstructive Pulmonary Disease (NHFlOscillo)

6 agosto 2026 aggiornato da: ADIR Association

Time Course of Respiratory Oscillometry Parameters During Exposure to Nasal High-Flow Therapy in People With Stable Chronic Obstructive Pulmonary Disease: A Prospective Open-Label Single-Arm Physiological Study

Chronic obstructive pulmonary disease (COPD) can affect the small airways and alter respiratory mechanics. Nasal high-flow therapy delivers warmed and humidified gas through nasal cannulas and may change airway resistance. Respiratory oscillometry is a noninvasive test that measures respiratory resistance and reactance during quiet breathing.

This prospective, single-center study will enroll 20 adults with severe or very severe stable COPD who have never used nasal high-flow therapy. During a single study visit lasting approximately 6 hours, participants will receive individualized nasal high-flow therapy for 4 hours. Respiratory oscillometry will be measured before exposure, immediately after device titration, and after 30, 60, 120, 180, and 240 minutes.

The primary objective is to describe the time course of the difference between respiratory resistance measured at 5 hertz and at 20 hertz (R5-R20), an indirect index of peripheral airway mechanical abnormalities. Secondary objectives are to describe changes in total and proximal respiratory resistance, respiratory reactance, resonant frequency, and area of reactance. The hypothesis is that nasal high-flow exposure will produce measurable, time-dependent changes in respiratory oscillometry parameters.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

NHFlOscillo is a prospective, open-label, single-center, single-arm physiological study involving adults with stable severe to very severe chronic obstructive pulmonary disease (COPD). The study is designed to characterize the time course of respiratory oscillometry parameters during a standardized 4-hour exposure to heated and humidified nasal high-flow therapy.

Participants will attend a single study visit and will be instructed to take their usual medications before the visit. After providing written informed consent, baseline characteristics will be recorded, and participants will complete the modified Medical Research Council Dyspnea Scale (mMRC), the St George's Respiratory Questionnaire (SGRQ), the COPD Assessment Test (CAT), and the Leicester Cough Questionnaire (LCQ). Baseline impulse oscillometry (IOS) will then be performed using a calibrated Vyntus IOS system, with the participant seated and breathing quietly, in accordance with current European Respiratory Society technical standards.

Nasal high-flow therapy will be initiated at a flow rate of 15 L/min and a temperature of 34 °C. After 3 minutes, the temperature will be increased to 37 °C if tolerated; otherwise, it will be maintained at 34 °C. The flow rate will then be increased every 3 minutes to an individualized level consistent with usual clinical practice, up to a maximum of 40 L/min. In participants receiving long-term oxygen therapy, supplemental oxygen will be titrated to maintain an oxygen saturation comparable to that observed under their usual conditions without nasal high-flow therapy.

The exposure will be continued for a total of 4 hours and will be briefly interrupted to perform oscillometry measurements immediately after titration and at 30, 60, 120, 180, and 240 minutes after the start of nasal high-flow therapy.

The target sample size is 20 participants. Changes in oscillometry parameters over time will be analyzed using linear mixed-effects models, with measurement time included as a fixed effect and participant included as a random effect. Each post-exposure time point will be compared with the pre-exposure baseline. Results will be reported as mean differences with 95% confidence intervals and interpreted according to the minimal clinically important difference for each outcome, when available.

Prespecified subgroup analyses will be conducted in participants receiving long-term oxygen therapy and in participants with cough and sputum production. Cough and sputum production will be identified using two alternative operational definitions:

CAT: a score ≥2 on both items 1 and 2; SGRQ: cough on most days or several days per week (response option 1 or 2 to the item "I cough") and sputum production on most days or several days per week (response option 1 or 2 to the item "I bring up sputum").

Tipo di studio

Interventistico

Iscrizione (Stimato)

20

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Francia
    • Normandy
      • Rouen, Normandy, Francia, 76000
        • ADIR Association
        • Contatto:
        • Investigatore principale:
          • Tristan Bonnevie, PhD

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

  • Age >18 years and <85 years;
  • Chronic obstructive pulmonary disease classified as Global Initiative for Chronic Obstructive Lung Disease (GOLD) spirometric grade III or IV;
  • Modified Medical Research Council dyspnea score ≥2;
  • Completed a pulmonary rehabilitation program at the study center;
  • Clinically stable, defined as no exacerbation and no treatment change during the previous 4 weeks;
  • With or without long-term oxygen therapy;
  • Never previously used nasal high-flow therapy;
  • Affiliated with a French social security system;
  • Able to read and understand the participant information and provide written informed consent.

Non-inclusion Criteria:

  • Under legal guardianship or curatorship;
  • Confirmed or suspected pregnancy;
  • Unable to provide informed consent;
  • Primary diagnosis of another chronic obstructive respiratory disease, such as asthma or primary bronchiectasis;
  • Severe or unstable cardiovascular disease, including uncontrolled cardiac arrhythmia, severe heart failure, recent myocardial infarction, or unstable angina;
  • Hemodynamic instability.

Exclusion Criteria:

• None

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Scienza basilare
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Nasal High-Flow Therapy
Participants receive individualized, heated and humidified nasal high-flow therapy (myAirvo 3, Fisher & Paykel Healthcare, New Zealand) for 4 hours during a single study visit, with repeated respiratory oscillometry assessments.
Dispositivo: Heated Humidified Nasal High-Flow Therapy
Therapy is initiated at 15 L/min and 34 °C. After 3 minutes, the temperature is increased to 37 °C if tolerated; otherwise it is returned to or maintained at 34 °C. Flow is increased every 3 minutes to an individualized clinically used level, up to 40 L/min. In participants receiving long-term oxygen therapy, supplemental oxygen is titrated to maintain a saturation comparable to the usual saturation without nasal high-flow therapy. Total exposure duration is 4 hours. The intervention is briefly interrupted for respiratory oscillometry immediately after titration and at 30, 60, 120, 180, and 240 minutes.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change From Baseline in Frequency Dependence of Respiratory Resistance (R5-R20)
Lasso di tempo: Baseline; immediately after individualized nasal high-flow titration; and 30, 60, 120, 180, and 240 minutes after starting nasal high-flow therapy.
Frequency dependence of respiratory resistance is calculated as respiratory resistance measured at 5 hertz minus respiratory resistance measured at 20 hertz (R5-R20). It is measured by impulse oscillometry using the Vyntus impulse oscillometry system (IOS) and expressed in kilopascals per liter per second (kPa/L/s). Percent-predicted values will also be reported when appropriate reference equations are available. The outcome is the change from the pre-exposure baseline at each post-baseline assessment during the exposure period. The registered measure is the repeated change from the pre-exposure baseline across the exposure period.
Baseline; immediately after individualized nasal high-flow titration; and 30, 60, 120, 180, and 240 minutes after starting nasal high-flow therapy.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change From Baseline in Total Respiratory Resistance at 5 Hertz (R5)
Lasso di tempo: Baseline; immediately after individualized nasal high-flow titration; and 30, 60, 120, 180, and 240 minutes after starting nasal high-flow therapy.
Total respiratory resistance at 5 hertz (R5) is measured by impulse oscillometry and expressed in kPa/L/s. Percentage of predicted values will also be reported when reference equations are available.
Baseline; immediately after individualized nasal high-flow titration; and 30, 60, 120, 180, and 240 minutes after starting nasal high-flow therapy.
Change From Baseline in Proximal Respiratory Resistance at 20 Hertz (R20)
Lasso di tempo: Baseline; immediately after individualized nasal high-flow titration; and 30, 60, 120, 180, and 240 minutes after starting nasal high-flow therapy.
Respiratory resistance at 20 hertz (R20), reflecting predominantly proximal airway resistance, is measured by impulse oscillometry and expressed in kPa/L/s. Percentage of predicted values will also be reported when reference equations are available.
Baseline; immediately after individualized nasal high-flow titration; and 30, 60, 120, 180, and 240 minutes after starting nasal high-flow therapy.
Change From Baseline in Respiratory Reactance at 5 Hertz (X5)
Lasso di tempo: Baseline; immediately after individualized nasal high-flow titration; and 30, 60, 120, 180, and 240 minutes after starting nasal high-flow therapy.
Respiratory reactance at 5 hertz (X5) is measured by impulse oscillometry and expressed in kPa/L/s. Percentage of predicted values will also be reported when reference equations are available.
Baseline; immediately after individualized nasal high-flow titration; and 30, 60, 120, 180, and 240 minutes after starting nasal high-flow therapy.
Change From Baseline in Resonant Frequency (Fres)
Lasso di tempo: Baseline; immediately after individualized nasal high-flow titration; and 30, 60, 120, 180, and 240 minutes after starting nasal high-flow therapy.
Resonant frequency (Fres) is measured by impulse oscillometry and expressed in hertz. Percentage of predicted values will also be reported when reference equations are available.
Baseline; immediately after individualized nasal high-flow titration; and 30, 60, 120, 180, and 240 minutes after starting nasal high-flow therapy.
Change From Baseline in Area of Reactance (AX)
Lasso di tempo: Baseline; immediately after individualized nasal high-flow titration; and 30, 60, 120, 180, and 240 minutes after starting nasal high-flow therapy.
Area of reactance (AX) is measured by impulse oscillometry and expressed in kPa/L. Percentage of predicted values will also be reported when reference equations are available.
Baseline; immediately after individualized nasal high-flow titration; and 30, 60, 120, 180, and 240 minutes after starting nasal high-flow therapy.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

ADIR Association

Collaboratori

Fisher and Paykel Healthcare
University of Rouen Normandie

Investigatori

  • Investigatore principale: Tristan Bonnevie, PhD, ADIR Association

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 settembre 2026

Completamento primario (Stimato)

29 febbraio 2028

Completamento dello studio (Stimato)

29 febbraio 2028

Date di iscrizione allo studio

Primo inviato

3 agosto 2026

Primo inviato che soddisfa i criteri di controllo qualità

3 agosto 2026

Primo Inserito (Effettivo)

6 agosto 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

10 agosto 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

6 agosto 2026

Ultimo verificato

1 agosto 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • NHFlOscillo

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

Data will be made available upon reasonable request for research purposes after publication. This includes de-identified data related to demographic characteristics, as well as endpoints published either in the main manuscript or any supplemental data. Requests should be sent to t.bonnevie@adir-hautenormandie.com

Periodo di condivisione IPD

Data will be made available after publication.

Criteri di accesso alla condivisione IPD

Data will be made available upon request for research purposes. Requests should be sent to t.bonnevie@adir-hautenormandie.com.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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