Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Breathing device tested to slow lung decline in ALS

NCT ID NCT05297487

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled This study
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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.

Vår säkerhetsrekommendation!

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.