Ignite Creation Date:
2024-05-06 @ 8:04 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06249412
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-08
First Post:
2024-01-26
Brief Title:
The Importance of Positive Expiratory Pressure Associated With the In-exsufflator in ALS Patients
Sponsor:
Groupe Hospitalier du Havre
Organization:
Groupe Hospitalier du Havre
Study Overview
Official Title:
The Importance of Positive Expiratory Pressure Associated With the In-exsufflator in Patients With Amyotrophic Lateral Sclerosis on the Effectiveness of Therapy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PEPINEX
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 INEXMI-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 dysfunctionResearch 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 therapys 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
Detailed Description:
Amyotrophic Lateral Sclerosis ALS is an incurable and debilitating neurodegenerative disease affecting both upper and lower motor neurons The average life expectancy upon diagnosis ranges from 2 to 7 years Treatment is symptomatic aiming to manage symptoms rather than cure the disease ALS can be classified as spinal when symptoms primarily affect the limbs or bulbar when the disease manifests with speech swallowing or coughing difficulties Regardless of the subtype ALS eventually affects all skeletal muscles including respiratory muscles leading to impaired coughing efficiency secretion buildup and increased lung infections Enhancing cough efficiency is crucial for clearing airway secretions and reducing pneumonia risk
In healthy individuals coughing involves an increase in lung volume by inspiratory muscles coordination of the glottis by laryngeal muscles and increased thoracoabdominal pressure by expiratory muscles This process is disrupted in ALS patients In-exsufflation therapy is widely used and recommended to assist coughing mechanically by applying non-invasive positive and negative pressure changes through a mask For MI-E to be effective and keep the upper airways open during therapy coordinated glottic movements are essential The ultimate goal is to increase peak expiratory flow PEF during coughing However in some patients MI-E is ineffective due to the collapse of the upper airways during both phases of the therapy-insufflation and exsufflation-but especially during inspiration possibly due to dysfunction of the muscles innervated by the brainstem
In 2017 Andersen et al demonstrated via laryngoscopies conducted during MI-E use that the therapy was associated with
Adduction of the supraglottic laryngeal structures during the insufflation phase
Retraction of the tongue base into the hypopharynx during insufflation Adduction of the vocal cords in ALS patients during both insufflation and exsufflation regardless of subtype
These factors compromised the therapys effectiveness which aims to increase PEF during cough
Andersen et al concluded that it is important to personalize and adjust the MI-E settings to reduce the risk of airway collapse and allow the maximum number of ALS patients to benefit from it
Today several MI-E devices are available on the market sharing similar settings for target pressure positivenegative inspiratoryexpiratory time automation etc Notably one particular device EOVE-70 Eove Pau offers the use and adjustment of a positive expiratory pressure PEP during the pause ie between each delivered cycle which could reduce the risk of airway collapse during therapy and improve cough expiratory flow rate as well as the tolerance and effectiveness of the treatment in ALS patients
The aim of this study is to evaluate the effect of using the positive expiratory pressure function during the pause and before the following insufflation on the peak expiratory flow rate of cough in patients with ALS during MI-E therapy
In healthy individuals coughing involves an increase in lung volume by inspiratory muscles coordination of the glottis by laryngeal muscles and increased thoracoabdominal pressure by expiratory muscles This process is disrupted in ALS patients In-exsufflation therapy is widely used and recommended to assist coughing mechanically by applying non-invasive positive and negative pressure changes through a mask For MI-E to be effective and keep the upper airways open during therapy coordinated glottic movements are essential The ultimate goal is to increase peak expiratory flow PEF during coughing However in some patients MI-E is ineffective due to the collapse of the upper airways during both phases of the therapy-insufflation and exsufflation-but especially during inspiration possibly due to dysfunction of the muscles innervated by the brainstem
In 2017 Andersen et al demonstrated via laryngoscopies conducted during MI-E use that the therapy was associated with
Adduction of the supraglottic laryngeal structures during the insufflation phase
Retraction of the tongue base into the hypopharynx during insufflation Adduction of the vocal cords in ALS patients during both insufflation and exsufflation regardless of subtype
These factors compromised the therapys effectiveness which aims to increase PEF during cough
Andersen et al concluded that it is important to personalize and adjust the MI-E settings to reduce the risk of airway collapse and allow the maximum number of ALS patients to benefit from it
Today several MI-E devices are available on the market sharing similar settings for target pressure positivenegative inspiratoryexpiratory time automation etc Notably one particular device EOVE-70 Eove Pau offers the use and adjustment of a positive expiratory pressure PEP during the pause ie between each delivered cycle which could reduce the risk of airway collapse during therapy and improve cough expiratory flow rate as well as the tolerance and effectiveness of the treatment in ALS patients
The aim of this study is to evaluate the effect of using the positive expiratory pressure function during the pause and before the following insufflation on the peak expiratory flow rate of cough in patients with ALS during MI-E therapy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None