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

6. august 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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").

Studietype

Intervensjonell

Registrering (Antatt)

20

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Frankrike
    • Normandy
      • Rouen, Normandy, Frankrike, 76000

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Grunnvitenskap
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Enhet: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change From Baseline in Frequency Dependence of Respiratory Resistance (R5-R20)
Tidsramme: 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.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change From Baseline in Total Respiratory Resistance at 5 Hertz (R5)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

ADIR Association

Samarbeidspartnere

Fisher and Paykel Healthcare
University of Rouen Normandie

Etterforskere

  • Hovedetterforsker: Tristan Bonnevie, PhD, ADIR Association

Publikasjoner og nyttige lenker

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Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. september 2026

Primær fullføring (Antatt)

29. februar 2028

Studiet fullført (Antatt)

29. februar 2028

Datoer for studieregistrering

Først innsendt

3. august 2026

Først innsendt som oppfylte QC-kriteriene

3. august 2026

Først lagt ut (Faktiske)

6. august 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

10. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

6. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • NHFlOscillo

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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

IPD-delingstidsramme

Data will be made available after publication.

Tilgangskriterier for IPD-deling

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

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Nei

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