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New breathing device could help ALS patients clear their lungs

NCT ID NCT05819931

Symptom relief Sponsor: University Hospital, Toulouse Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This pilot study tests a mechanical in-exsufflator (MIE) device that helps ALS patients cough more effectively by pushing air in and then pulling it out. The goal is to see if daily use for four weeks can maintain or improve lung function. The study will enroll 36 adults with ALS who have a weak cough.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Mechanical In-Exsufflator (MIE) device
What this could lead to
If it works, this device could help ALS patients clear their airways more easily, potentially slowing respiratory decline and improving quality of life.
What could go wrong
This is a small pilot study with only 36 participants, so results may not apply to all ALS patients. The device is meant to ease symptoms, not stop or reverse the disease.

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.

Participants

About 36 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2023

Expected to finish

Dec 2026

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 to 100 years

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: * Confirmed ALS categorized as probable or certain according to the revised Awaji-Shima criteria \[27\]. * ALS of spinal, bulbar or respiratory forms * Peak Flow measure between 160 and 255 L/min (recommendation of MIE in case of congestion, with the possibility of daily sessions) * Patient who has not benefited from treatment by MIE in the past year (less than 10 sessions in total) * Patient able to use the MIE and perform the collection, or having a caregiver able to help * Patient receiving physiotherapist treatment greater than or equal to twice a week Exclusion Criteria: * Psychiatric (DSM-5) or cognitive disorders incompatible with participation in the study * Contraindication to the use of an MIE (pneumothorax for example) * Insufficient level in French for understanding the study and completing the questionnaires * Current or past participation in another innovative research or care program relating to respiratory functions * Emergency situation for which the MIE must be set up within less than a week Exclusion during the study : * Appearance of a serious contraindication to the practice of MIE during the study (for example rib fracture during a fall) * Patient's physiotherapist refusing to do the study

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Conditions

The condition(s) this trial relates to.

amyotrophic lateral sclerosis Cough

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Amyotrophic lateral sclerosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • SLA Center - Purpan University Hospital Toulouse, FRANCE

    RECRUITING

    Toulouse, Occitanie, 31000, France

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