RecruitingNot ApplicableNCT05819931

Breathing With Amyotrophic Lateral Sclerosis

Evaluation of the Effect of Respiratory Physiotherapy by Mechanical In-exsufflator on Respiratory Function in Patients With Amyotrophic Lateral Sclerosis: A Pilot Study


Sponsor

University Hospital, Toulouse

Enrollment

36 participants

Start Date

Aug 29, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The study aims to evaluate the effect of mechanical insufflator-exsufflator on the respiratory functions of Amyotrophic Lateral Sclerosis (ALS) patients evaluated via peak expiratory flow on cough (PEFC) measurements. The evolution of their PEFC is monitored to see if the curative management can have a positive impact on the latter.


Eligibility

Min Age: 18 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This study looks at whether a device called a Mechanical Insufflator-Exsufflator (MIE) — sometimes called a cough assist machine — can help people with Amyotrophic Lateral Sclerosis (ALS) breathe and clear their airways more effectively. ALS is a progressive disease that weakens the muscles, including those used for breathing. Over time, people with ALS often struggle to cough forcefully enough to clear mucus from their lungs, which can lead to serious respiratory infections. The MIE device helps by simulating a strong, effective cough. To be eligible, participants must have a confirmed ALS diagnosis with spinal, bulbar, or respiratory involvement, a peak flow measurement between 160 and 255 L/min, and must not have received MIE treatment more than 10 times in the past year. Participants need to see a physiotherapist at least twice a week and be able to use the device themselves or with a caregiver's assistance. The study is conducted in French, so participants must have sufficient French language comprehension. Participants will use the MIE device regularly and be followed over time to see whether it improves their breathing capacity, quality of life, and ability to manage respiratory symptoms. This study is important because respiratory failure is one of the leading causes of death in ALS, and better tools to delay its onset could meaningfully extend and improve the lives of people living with this condition.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEMechanical In-Exsufflator treatment

The Mechanical In-Exsufflator (MIE) is a device that alternately inhales and exhales air and amplifies the respiratory cycles in flow and pressure. 15 breathing cycles (about 3 minutes) are recommended each day. Patients will practice the MIE daily independently and/or carried out by his physiotherapist (PT) during PT sessions. The MIE is prescribed by the neurologist or pulmonologist and is covered by social security in France. It is gifted by an external service provider. The Peak-Flow Cough is considered as the standardized score retaining the best of 3 consecutive measurements by Peak-Flow, a small portable device for personal use, which measures the maximum expiratory flow reached by the patient at the moment when the breath is most powerful. The patient is his own control. At baseline, the patient will be treated as usual. He will be asked to read the Peak-Flow Cough measures. The PT will also perform the Peak flow measurement at each patient visit.


Locations(1)

SLA Center - Purpan University Hospital Toulouse, FRANCE

Toulouse, Occitanie, France

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NCT05819931


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