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

6 sierpnia 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Szczegółowy opis

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").

Typ studiów

Interwencyjne

Zapisy (Szacowany)

20

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

  • Francja
    • Normandy
      • Rouen, Normandy, Francja, 76000

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Podstawowa nauka
  • Przydział: Nie dotyczy
  • Model interwencyjny: Zadanie dla jednej grupy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Urządzenie: 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change From Baseline in Frequency Dependence of Respiratory Resistance (R5-R20)
Ramy czasowe: 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.

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Change From Baseline in Total Respiratory Resistance at 5 Hertz (R5)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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.

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

ADIR Association

Współpracownicy

Fisher and Paykel Healthcare
University of Rouen Normandie

Śledczy

  • Główny śledczy: Tristan Bonnevie, PhD, ADIR Association

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 września 2026

Zakończenie podstawowe (Szacowany)

29 lutego 2028

Ukończenie studiów (Szacowany)

29 lutego 2028

Daty rejestracji na studia

Pierwszy przesłany

3 sierpnia 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

3 sierpnia 2026

Pierwszy wysłany (Rzeczywisty)

6 sierpnia 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

10 sierpnia 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

6 sierpnia 2026

Ostatnia weryfikacja

1 sierpnia 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • NHFlOscillo

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu 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

Ramy czasowe udostępniania IPD

Data will be made available after publication.

Kryteria dostępu do udostępniania IPD

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

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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