Breathing device tested to slow lung decline in ALS
NCT ID NCT05297487
First seen Sep 16, 2026 · Last updated Sep 17, 2026 · Updated 1 time
Summary
ALS weakens the muscles that control breathing, and doctors often turn to a ventilator as the disease progresses. This trial tests whether using a pressure-relaxer device early, which helps expand the chest and clear the airways, can slow the loss of lung function. Adults with ALS who show early signs of breathing muscle weakness join the study. Researchers compare lung volume changes between those who use the device alongside standard care and those who receive standard care alone.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a pressure relaxer device that uses intermittent positive pressure breathing
- What this could lead to
- If it works, early use of this breathing device could help people with ALS keep their lung function longer and delay the need for a ventilator.
- What could go wrong
- This is a small, early study in a rare disease, so the results may not hold up in larger trials. The device may not slow lung decline enough to make a meaningful difference.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Expected to start
-
Jul 2025
An estimate. Start dates often move.
- Expected to finish
-
Jul 2028
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Adult patient (over 18 years old) with a diagnosis of ALS, * \- Patient who presents with an impairment of the strength of the inspiratory muscles corresponding to the degradation of the Measurement of the maximum inspiratory pressure (MIP) and/or of the inspiratory pressure during the maximum sniffle (SNIP): * Decrease in SNIP or MIP by 10% of previous values (measured at the last follow-up visit to the center in its standard care) * If it is his first consultation (no previous value) we will include patients if they have SNIP or MIP values \<90% of the theoretical values provided by the spirometer measuring the pressures. The SNIPs and MIPs (+/-1 standard deviation) must be disturbed for inclusion of the patient. * Patient not yet using RLX for lung recruitment or Patient using RLX only as a decluttering aid. * Person affiliated or beneficiary of a social security scheme. * Free, informed and written consent signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research). Exclusion Criteria: * Patient with advanced restrictive impairment = FVC\<50% of theoretical values on inclusion * Patient with proven alveolar hypoventilation or treated with non-invasive ventilation * Patient already treated with RLX for pulmonary recruitment * Persons referred to in Articles L1121-5 to L1121-8 of the CSP (corresponding to all protected persons: pregnant woman, parturient, breastfeeding mother, person deprived of liberty by judicial or administrative decision, minor, and person making object of a legal protection measure: guardianship or curatorship) * Patient with a contraindication to the use of RLX (1): * Pneumothorax * Known intracranial hypertension * Hemodynamic instability * Facial or skull surgery \<6 months * Tracheoesophageal fistula * Active bleeding * Untreated active tuberculosis * Rebellious Hiccup * the history of known emphysematous or bullous pathologies
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Amyotrophic lateral sclerosis are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can hospital codes reliably track home ventilation in ALS?
- Can a synthetic compound be safe enough to test in ALS? early trial asks
- Can a cheap gout drug slow ALS? trial puts colchicine to the test
- Can donor gut bacteria reshape the immune system in ALS?
- Spinal injection drug targets genetic cause of ALS and dementia
- Can amniotic cell secretions shield nerves in ALS and MS?