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NCT Number: NCT07170865

Dynamic Impact of NIV on Diaphragmatic Ultrasound in Patients With Amyotrophic Lateral Sclerosis

The goal of this pilot observational study is to learn about the dynamic impact of the non invasive ventilation on the diaphragm in patient with amyotrophic lateral sclerosis. The main question it aims to answer : can diaphragmatic ultrasound detect differences in diaphragmatic motion (diaphragmactic excursion and diaphragmatic thickening between spontaneous breathing and non-invasive ventilation ?

Participants will receive diaphragmatic ultrasound assessments both under spontaneous breathing and during non-invasive ventilation on their day hospital evaluation for ventilatory support.

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Key information

Conditions

Amyotrophic Lateral Sclerosis (ALS) Amyotrophic Lateral Sclerosis Central Nervous System Diseases Metabolic Diseases Motor Neuron Disease Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases Non Invasive Ventilation (NIV) Nutritional and Metabolic Diseases Proteostasis Deficiencies Spinal Cord Diseases TDP-43 Proteinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

Each diaphragmatic ultrasound assessment will be performed on both the right and left hemidiaphragms, with the patient in a semi-recumbent position at 30°, during a maximal inspiratory effort. The following parameters will be measured:

  • Diaphragmatic excursion using M-mode ultrasound with a low-frequency convex (abdominal) probe via a subcostal approach
  • Diaphragmatic thickening using B-mode ultrasound with a high-frequency linear (vascular) probe via the lateral axillary line

Measurements will be obtained during spontaneous breathing and after 10 to 20 minutes of non-invasive ventilation (NIV), using ventilator settings deemed optimally adjusted by the supervising physician.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult patient (≥18 years old)
  • Diagnosis of bulbar or spinal amyotrophic lateral sclerosis (ALS) established by a neurologist
  • Indication for non-invasive ventilation (NIV) confirmed by the referring pulmonologist for daytime and/or nocturnal alveolar hypoventilation

Exclusion criteria

  • Continuous (24-hour) non-invasive ventilation
  • Patient refusal to participate
  • Individual under legal guardianship or judicial protection

Treatment and study plan

Primary outcomes

  1. Composite : - Diaphragmatic excursion variation (DE) - Diaphragmatic thickening variation (DT)

    Time frame: Day 1

    Both DE and DT will be measured under spontaneous bretahing and under NIV. The outcomes will be compared, and the percentage variation between the two conditions will be recorded

Secondary outcomes

  1. Changes in transcutaneous carbon dioxide (TcCO₂) levels

    Time frame: Day 1

    The variation in TcCO₂ will be measured and compared with the variations in DE and DT to determine whether there is a correlation.

  2. NIV Tolerance

    Time frame: Day 1

    NIV tolerance will be assessed using a numerical subjective scale from 0 to 10. The tolerance numercial scale will then be compared with variations in DE and DT to determine whether there is a correlation.

  3. Pathophysiological type of ALS

    Time frame: Day 1

    For each patient, the bulbar type or the spinal type of ALS will be recorded. Subgroups analyses between spinal ALS and bulbar ALS. Some differences are to be expected.

  4. Adherence of NIV

    Time frame: Day 1

    If a NIV is already instaured, the average adherence in hours per 24 hours will be recorded

    • Subgroupes analyses between < 8 hours/24h NIV adherence, and 8 hours/24h or more NIV adherence

Study contacts

Contact information is provided by the study sponsor or research team.

Christel Saint Raymond, Doctor

CONTACT

[email protected]

+33 4 76 76 54 53

Hugo Vanderstraete, Resident

CONTACT

[email protected]

+33 6 78 34 08 51

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Official study title

Assessment of the Dynamic Impact of Non-Invasive Ventilation on Diaphragmatic Ultrasound in Patients With Amyotrophic Lateral Sclerosis

Acronym: EchoDia

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 12, 2025
Registry last updated
Sep 12, 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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