The Importance of Positive Expiratory Pressure Associated With the In-exsufflator in ALS Patients

Recruiting now · Not applicable

Conditions studied: Amyotrophic Lateral Sclerosis ALS7

In brief

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.

Key facts

Study ID

NCT06249412

Run by

Groupe Hospitalier du Havre

People needed

11

Starts

2024-12-19

Expected to finish

2027-03-01

Last updated by the study team

2026-01-21

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• "● 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 is running

• GH Havre — Le Havre, Normandy, France (enrolling)

Full record on ClinicalTrials.gov

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