Improving cough assistance in ALS patients using a specialized device
Official title: The Importance of Positive Expiratory Pressure Associated With the In-exsufflator in Patients With Amyotrophic Lateral Sclerosis on the Effectiveness of Therapy
Run by Groupe Hospitalier du Havre · NCT06249412 · Data updated 2026-11-12
This study is testing a special device to see if it can help people with ALS cough better and clear their airways more effectively.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 100 Years |
| Sex | All |
| Enrollment | 11 (estimated) |
| Sponsor | Groupe Hospitalier du Havre Academic / other |
| Locations | 1 site (Le Havre, Normandy) |
| Status | Recruiting |
| Started | December 19, 2024 |
| Main results expected | December 1, 2026 |
| Study ends | March 1, 2027 |
| Registry record updated | January 21, 2026 |
| Trial ID | NCT06249412 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults over 18 with ALS, particularly those experiencing bulbar symptoms like speech or swallowing difficulties.
✕Probably not a fit
Patients with recent respiratory infections or mental illnesses that hinder device use may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the effectiveness of mechanical in-exsufflation therapy (MI-E) combined with positive expiratory pressure (PEP) in patients with Amyotrophic Lateral Sclerosis (ALS). It aims to enhance cough efficiency and airway clearance by adjusting MI-E settings to prevent airway collapse, which is a common issue in ALS patients. Participants will be either new to INEX therapy or already using it, and they will be monitored for improvements in respiratory function and cough effectiveness. The study is conducted at the Groupe Hospitalier du Havre and involves collaboration with the French Physiotherapy Society.
Why it matters
Potential benefit: If successful, this approach could significantly improve respiratory function and reduce the risk of lung infections in ALS patients.
How similar studies have gone: Previous research has indicated potential benefits of individualized MI-E settings, suggesting that this approach may build on established findings.
Who can join: the full rules
Show full inclusion / exclusion criteria
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"
Where it's running
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GH Havre
Le Havre, Normandy, France Recruiting
Study contacts
- Study coordinator: Yann Combret, PT, PhD
- Email: yann.combret@ch-havre.fr
- Phone: +332 32 73 32 32
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.