Nasal High-flow Oxygen Therapy During Acute Exercise in Fibrotic Interstitial Lung Disease

Not Applicable

Completed

• Conditions: Interstitial Lung Disease (ILD)

• Registration Number: NCT07129707
• Lead Sponsor: Dieulefit Santé Centre de Réadaptation

Brief Summary

Hallmarks of fibrotic interstitial lung disease (f-ILD) include severe hypoxemia, dyspnea and exercise limitation. Although ambulatory oxygen (O2) therapy is widely prescribed, standard low-flow O2 systems (nasal prongs) fail to meet patients' inspiratory demand on exertion resulting in incomplete correction of hypoxemia and limited symptomatic relief. Nasal high-flow O2 therapy (NHFO2) delivers heated, humidified, and O2-enriched air at high flow rates. It has recently emerged as a promising alternative to overcome the pre-specified limitations: NHFO2 is more effective in correcting hypoxemia and reducing dyspnea vs standard O2 therapy and consistently improved exercise capacity in f-ILD. In fact, NHF per se may exert independent physiological benefits such as washout of the anatomical dead space and reduced work of breathing. However, the respective effect of respiratory support and improved oxygenation on dyspnea and exercise tolerance remain unexplored in f-ILD. To address this gap in knowledge, this prospective, randomized-controlled trial aimed to disentangle the i) independent and ii) combined effects of respiratory support and supplemental O2 on dyspnea and exercise tolerance in patients with f-ILD.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-01
• Primary Completion: 2025-01-31
• Study Completion: 2025-01-31
• Status Verified: 2025-08
• Study First Submitted: 2025-08-09
• Study First Submitted QC: 2025-08-15
• Last Update Submitted: 2025-08-15
• Study First Posted: 2025-08-19
• Last Update Posted: 2025-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• diagnosis of fibrotic interstitial lung disease (regardless of etiology)
• age ≥18 years
• modified Medical Research Council scale ≥1
• stable condition (no acute exacerbation within the preceding 3 months)

Exclusion Criteria

• inability to perform a cardiopulmonary exercise test (CPET) on a bicycle ergometer
• participation in a pulmonary rehabilitation program within the last 6 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Time to exercise intolerance	4 times over 2 consecutive days (1 time per experimental condition)	Measured during a constant work-rate exercise test (70% peak work rate)
Isotime dyspnea	4 times over 2 consecutive days (1 time per experimental condition)	0-10 category-ratio Borg scale

Secondary Outcome Measures

Name	Time	Method
Breathing pattern	4 times over 2 consecutive days (1 time per experimental condition)	Respiratory inductive plethysmography
Gas exchange	4 times over 2 consecutive days (1 time per experimental condition)	Earlobe capnography
Quadriceps muscle oxygenation	4 times over 2 consecutive days (1 time per experimental condition)	Near-infrared spectroscopy

Trial Locations

Locations (1)

Centre de Réadaptation Cardio-Respiratoire Dieulefit Santé; 🇫🇷 Dieulefit, Auvergne Rhone-Alpes, France