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Completed

NCT Number: NCT07129707

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre de Réadaptation Cardio-Respiratoire Dieulefit Santé

Dieulefit, Auvergne-Rhône-Alpes, 26220, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

exercise testing

Other

Each participant performs a constant work-rate exercise test (70% peak work rate) under the 4 experimental conditions (referred as arms).

Primary outcomes

  1. Time to exercise intolerance

    Time frame: 4 times over 2 consecutive days (1 time per experimental condition)

    Measured during a constant work-rate exercise test (70% peak work rate)

  2. Isotime dyspnea

    Time frame: 4 times over 2 consecutive days (1 time per experimental condition)

    0-10 category-ratio Borg scale

Secondary outcomes

  1. Breathing pattern

    Time frame: 4 times over 2 consecutive days (1 time per experimental condition)

    Respiratory inductive plethysmography

  2. Gas exchange

    Time frame: 4 times over 2 consecutive days (1 time per experimental condition)

    Earlobe capnography

  3. Quadriceps muscle oxygenation

    Time frame: 4 times over 2 consecutive days (1 time per experimental condition)

    Near-infrared spectroscopy

Sponsors and collaborators

Lead sponsor

Dieulefit Santé Centre de Réadaptation

Other

Registry information

Official study title

Does Nasal High-flow Oxygen Potentiate the Effects of Rehabilitative Exercise Training in Chronic Fibrotic Interstitial Lung Disease?

Acronym: PID-OXacute

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Aug 19, 2025
Registry last updated
Aug 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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