Time Course of Respiratory Oscillometry Parameters During Nasal High-Flow Therapy in Stable COPD

NCT07750613 | Not Yet Recruiting

• 1 other identifier: NHFlOscillo
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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 non-invasive 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 one approximately 6-hour visit, participants will receive individualized nasal high-flow therapy for 4 hours. 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 frequency dependence of respiratory resistance (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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

Nasal high-flow therapy; High-flow nasal cannula; Respiratory oscillometry; Impulse oscillometry; Small airways; Respiratory mechanics

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Frequency Dependence of Respiratory Resistance (R5-R20)

  Frequency dependence of resistance is calculated as respiratory resistance at 5 Hz minus resistance at 20 Hz (R5-R20) and is measured by impulse oscillometry using the Vyntus IOS. Values are expressed in kPa/L/s. Percentage of predicted values will also be reported when reference equations are available. 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.

Secondary Outcomes (5)

• Change From Baseline in Total Respiratory Resistance at 5 Hz (R5)

  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 Hz (R20)

  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 Hz (X5)

  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)

  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)

  Baseline; immediately after individualized nasal high-flow titration; and 30, 60, 120, 180, and 240 minutes after starting nasal high-flow therapy.

Study Arms (1)

Nasal High-Flow Therapy

EXPERIMENTAL

Participants receive individualized heated, humidified nasal high-flow therapy (myAirvo 3, Fisher Paykel Healthcare, NZ) for 4 hours during a single study visit, with repeated respiratory oscillometry assessments.

Device: Heated Humidified Nasal High-Flow Therapy

Interventions

Heated Humidified Nasal High-Flow Therapy DEVICE

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.

Nasal High-Flow Therapy

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18 years and \<85 years;
• Chronic obstructive pulmonary disease, GOLD stage 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.
• 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.

You may not qualify if:

• None

Sponsors & Collaborators

• ADIR Association: lead
• University of Rouen Normandie: collaborator
• Fisher and Paykel Healthcare: collaborator

Study Sites (1)

ADIR Association

Rouen, Normandy, 76000, France

Location

Related Publications (2)

• Abdo M, Kirsten AM, von Mutius E, Kopp M, Hansen G, Rabe KF, Watz H, Trinkmann F, Bahmer T; ALLIANCE study group. Minimal clinically important difference for impulse oscillometry in adults with asthma. Eur Respir J. 2023 May 5;61(5):2201793. doi: 10.1183/13993003.01793-2022. Print 2023 May.

  PMID: 36758985 BACKGROUND

• Kuo YL, Chien CL, Ko HK, Lai HC, Lin TL, Lee LN, Chang CY, Shen HS, Lu CC. High-flow nasal cannula improves respiratory impedance evaluated by impulse oscillometry in chronic obstructive pulmonary disease patients: a randomised controlled trial. Sci Rep. 2022 Apr 28;12(1):6981. doi: 10.1038/s41598-022-10873-x.

  PMID: 35484186 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Tristan Bonnevie, PhD

  ADIR Association

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tristan Bonnevie, PhD

CONTACT

0235592970; t.bonnevie@adir-hautenormandie.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants receive the same 4-hour exposure to individualized, heated, humidified nasal high-flow therapy. Repeated respiratory oscillometry measurements are obtained before and during exposure to characterize time-dependent physiological changes.

Study Record Dates

• First Submitted: August 3, 2026
• First Posted: August 6, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): February 29, 2028
• Study Completion (Estimated): February 29, 2028
• Last Updated: August 6, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be made available after publication.
• Access Criteria: Data will be made available upon request, for research purpose. Request should be send to t.bonnevie@adir-hautenormandie.com

Locations

FR (1)