The Importance of Positive Expiratory Pressure Associated with the In-exsufflator in Patients with Amyotrophic Lateral Sclerosis on the Effectiveness of Therapy

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
GH Havre
RECRUITING
Le Havre
Contact Information
Primary
Yann Combret, PT, PhD
yann.combret@ch-havre.fr
+332 32 73 32 32
Time Frame
Start Date: 2024-12-19
Estimated Completion Date: 2027-03-01
Participants
Target number of participants: 11
Treatments
Experimental: MI-E with Positive expiratory pressure during pause (PEP)
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)
Active_comparator: MI-E without Positive expiratory pressure during pause (PEP)
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)
Sponsors
Collaborators: French Physiotherapy Society / Société Français de Physiothérapie
Leads: Groupe Hospitalier du Havre

This content was sourced from clinicaltrials.gov