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

NCT06249412 | Recruiting

• 1 other identifier: 2023-A01269-36
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Amyotrophic Lateral Sclerosis ALS7

Keywords

ALS; Amyotrophic Lateral Sclerosis; MI-E therapy; INEX therapy; Airway clearance technics; Neuromuscular disease; Cough assit

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  Between 5 and 15 minutes (MI-E treatment period)

Secondary Outcomes (5)

• The average difference in inspiratory volume in mililiters with the use of the PEP function and without the use of this function.

  Between 5 and 15 minutes (MI-E treatment period)

• The perceived effect of PEP during pause on the effectiveness of MI-E therapy by the patient as well as their perceived comfort

  Between 5 and 15 minutes (MI-E treatment period)

• Qualitative analysis of cough using flow/time graphs of patient coughs with the use of the PEP function and without the use of this function.

  Between 5 and 15 minutes (MI-E treatment period)

• Comparison of PEF (Peak Expiratory Flow) reported by the MI-E machine versus PEF measured by the external pneumotachograph in L/min

  Between 5 and 15 minutes (MI-E treatment period)

• Comparison of Inspiratory Volume reported by the MI-E machine versus Inspiratory Volume measured by the external pneumotachograph in mililiters

  Between 5 and 15 minutes (MI-E treatment period)

Study Arms (2)

MI-E with Positive expiratory pressure during pause (PEP)

EXPERIMENTAL

With the MI-E EOVE-70 device, it is possible to enable the setting of PEP (Positive Expiratory Pressure) during the pause. When this setting is activated, PEP can be adjusted between 1 and 20 cmH2O. The MI-E session will last, depending on patient tolerance, between 8 and 15 minutes. In this study, the MI-E will be set in automatic or semi-automatic mode with settings proposed by the physiotherapists based on the effectiveness and tolerance of the patient. To titrate PEP, the practitioner will start at 8 cmH2O; the setting can be decreased or increased at the discretion of the practitioner to optimize it, based on the inspiratory volume and peak expiratory flow (PEF) measured by the device at each cycle (usual clinical practice). The practitioner can adjust PEP between a minimum of 4 and a maximum of 15 cmH2O. A wash-out period of 30 minutes is planned between each INEX session with and without the PEP function activated (Experimental arm and comparative arm)

Device: MI-E with PEP function activated during the pause

MI-E without Positive expiratory pressure during pause (PEP)

ACTIVE COMPARATOR

The MI-E session will last, depending on patient tolerance, between 8 and 15 minutes. In this study, the MI-E will be set in automatic or semi-automatic mode with settings proposed by the physiotherapists based on the effectiveness and tolerance of the patient. The PEP function will not be used by the practitioner (ie. 0 cmH2O of PEP during the pause). A wash-out period of 30 minutes is planned between each INEX session with and without the PEP function activated (Experimental arm and comparative arm)

Device: MI-E without PEP function activated during the pause

Interventions

MI-E with PEP function activated during the pause DEVICE

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 with Positive expiratory pressure during pause (PEP)

MI-E without PEP function activated during the pause DEVICE

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)

MI-E without Positive expiratory pressure during pause (PEP)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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 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.
• Death from any cause"

Sponsors & Collaborators

• Groupe Hospitalier du Havre: lead
• French Physiotherapy Society / Société Français de Physiothérapie: collaborator

Study Sites (1)

GH Havre

Le Havre, Normandy, 76290, France

RECRUITING

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis 7; Amyotrophic Lateral Sclerosis; Neuromuscular Diseases

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Yann Combret, PT, PhD

CONTACT

+332 32 73 32 32; yann.combret@ch-havre.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The participant (patient) will not see the treatment mode set on their INEX/MI-E. Only the care givers will know.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2024
• First Posted: February 8, 2024
• Study Start: December 19, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: January 21, 2026

Record last verified: 2026-01

Locations

FR (1)