Could a simple pressure adjustment help ALS patients breathe easier?
NCT ID NCT06249412
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at whether adding a specific pressure setting (PEP) to a standard cough-assist machine can help people with ALS cough more effectively. ALS weakens the muscles needed to cough, raising the risk of lung infections. The trial will compare cough strength with and without the extra pressure in 11 adults with ALS who already use or are starting cough-assist therapy.
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
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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
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About 11 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2024
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 100 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Male or female patient aged over 18 years * Patient with Amyotrophic Lateral Sclerosis (ALS) * Patients with established or beginning bulbar disorders, identified by the healthcare team (speech impairment, hypersalivation, or swallowing difficulties) * Patient naive to INEX therapy but prescribed for its installation or patient already treated by an INEX device * Patient followed by the ALS mobile team of the Groupe Hospitalier du Havre or the CHU of Dijon * Patient whose disease progression kinetics is medically deemed compatible with inclusion in the study * Patient willing to participate in the research after receiving adequate information and the information letter. * Patient affiliated with social security or a beneficiary of such a scheme. Exclusion Criteria: "● Patient not presenting an episode of infection or a past episode of respiratory infection less than one month old * Mental illness interfering with the proper use of the device * History of laryngospasm * Inability to come for consultation with the ALS team of the Groupe Hospitalier du Havre or the CHU of Dijon * Pregnancy * Person deprived of liberty by judicial or administrative decision, person subject to a legal protection measure (patient under guardianship or curatorship) Article L1121-8. * Appearance of a non-inclusion criterion * Refusal to participate after inclusion * Death from any cause"
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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GH Havre
RECRUITINGLe Havre, Normandy, 76290, France