NCT06249412Recruiting
The Importance of Positive Expiratory Pressure Associated With the In-exsufflator in ALS Patients
The Importance of Positive Expiratory Pressure Associated With the In-exsufflator in Patients With Amyotrophic Lateral Sclerosis on the Effectiveness of Therapy
Source: ClinicalTrials.gov · Last updated 21 Jan 2026
Brief summary (registry, in English)
Amyotrophic Lateral Sclerosis (ALS) is a fatal neurodegenerative disorder that impairs motor neurons, with a life expectancy of 2 to 7 years after diagnosis. ALS manifests as 'spinal' when it primarily affects limbs, or 'bulbar' when it impairs speech and swallowing. The disease progressively weakens all skeletal muscles, causing respiratory issues and increased risk of lung infections due to ineffective coughing. Mechanical cough assistance via In-exsufflation therapy/ mechanical in-exsufflator devie (INEX/MI-E) applies positive and negative airway pressures non-invasively to improve coughing. However, MI-E may fail in some ALS patients due to airway collapse, often related to brainstem muscle dysfunction.Research by Andersen et al. in 2017 highlighted that during MI-E, ALS patients often experience adverse laryngeal movements, which can obstruct airways and reduce the therapy's effectiveness. To combat this, they suggested individualized MI-E settings to minimize airway collapse. Modern MI-E devices, such as the EOVE-70, offer adjustable positive expiratory pressure (PEP) between cycles to potentially enhance airway stability and coughing efficiency. The current study focuses on the impact of PEP during therapy pauses on the peak expiratory flow rate in ALS patients, which could lead to improved therapeutic outcomes.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 11 (estimated)
- First submitted
- 26 Jan 2024
- Start date
- 19 Dec 2024
- Primary completion date
- 1 Dec 2026
- Lead sponsor
- Groupe Hospitalier du Havre
- Diseases
- ALS (motor neurone disease)
- NCT number
- NCT06249412
What you commit to
- Study type: Interventional
- Planned participants: 11
- From 19 Dec 2024 to the primary completion date, 1 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- "● 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
Other
- 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"
Who the study is looking for
- 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.
Age in the registry: 18 years to 100 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| GH Havre Coordinator of this site? Confirm its status | Le Havre | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.