Improving cough assistance in ALS patients using a specialized device
The Importance of Positive Expiratory Pressure Associated With the In-exsufflator in Patients With Amyotrophic Lateral Sclerosis on the Effectiveness of Therapy
NA · Groupe Hospitalier du Havre · NCT06249412
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 11 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Groupe Hospitalier du Havre (other) |
| Locations | 1 site (Le Havre, Normandy) |
| Trial ID | NCT06249412 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with ALS, particularly those experiencing bulbar symptoms like speech or swallowing difficulties.
Not a fit: Patients with recent respiratory infections or mental illnesses that hinder device use may not benefit from this study.
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 performed: Previous research has indicated potential benefits of individualized MI-E settings, suggesting that this approach may build on established findings.
Eligibility criteria
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 this trial is running
Le Havre, Normandy
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Amyotrophic Lateral Sclerosis ALS7, ALS, Amyotrophic Lateral Sclerosis, MI-E therapy, INEX therapy, Airway clearance technics, Neuromuscular disease, Cough assit