Testing a Pressure Setting on Cough Machines in People With ALS

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with amyotrophic lateral sclerosis (ALS) who already have, or are starting to have, speech, saliva or swallowing problems. They use or are about to start a cough-assist device (INEX).

Age

Over 18 years (up to 100 years)

Sex

Men and women

Disease stage

ALS with established or beginning bulbar problems (speech impairment, hypersalivation or swallowing difficulties). The disease must be moving at a pace the doctors judge compatible with the study.

Earlier treatment

Either new to INEX therapy but prescribed it, or already treated with an INEX device.

Main reasons for not taking part

• Current respiratory infection, or one less than a month ago
• Mental illness that gets in the way of using the device
• History of laryngospasm
• Pregnancy
• Cannot come to consultations with the ALS team at Le Havre or Dijon

The registry criteria, word for word

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

• Are you between 18 and 100 years old?YesNo

What the trial wants to find out

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.

The 2 groups in the trial

• MI-E with Positive expiratory pressure during pause (PEP)Treatment being tested

  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)

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

• MI-E without Positive expiratory pressure during pause (PEP)Existing treatment, for comparison

  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)

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