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

NCT06249412 · tracked via the Priya Life Science France tracker

Sponsor

Groupe Hospitalier du Havre

Phase

Not applicable

Started

2024-12-19

Last updated

2026-01-21

Condition(s) studied

Amyotrophic Lateral Sclerosis ALS7

Investigational drug(s) / intervention(s)

MI-E with PEP function activated during the pauseMI-E without PEP function activated during the pause

MI-E with PEP function activated during the pause: PEP function will be activated during the pause when using the EOVE-70. The PEP function in cmH2O will start at 8 cmH2O; the PEP setting can be decreased or increased at the discretion of the practitioner to optimize. The other therapeutic settings (positive pressure, negative pressure, inspiratory time, expiratory time and pause time) will be set individually for each patient by an experienced physiotherapist in order to reach the best clinical efficacy (usual clinical care)

MI-E without PEP function activated during the pause: The PEP function will not be activated during the pause when using the EOVE-70. The other therapeutic settings (positive pressure, negative pressure, inspiratory time, expiratory time and pause time) will be set individually for each patient by an experienced physiotherapist in order to reach the best clinical efficacy (usual clinical care)

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

100 Years

Healthy volunteers

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"

Primary outcome measure(s)

The average difference in PEF (Peak Expiratory Flow) in L/min with the use of the PEP function and without the use of this function. — Between 5 and 15 minutes (MI-E treatment period)
We aim to study the effect of using PEP during the pause on cough peak expiratory flow (PEF) in patients with ALS during MI-E therapy. The PEF from all treatment cycles measured by an external pneumotachograph connected to the circuit between the machine and the patient will be averaged and compared between the arms: with and without PEP during the pause

Trial sites (1)

Facility	City	Region	Status
GH Havre	Le Havre	Normandy	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06249412 on ClinicalTrials.gov ↗ ← All trials in France