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Evaluation of the Early Use of the Pressure Relaxer in the Respiratory Impairment of Patients With Amyotrophic Lateral Sclerosis: Multicenter Randomized Controlled Study.

NCT05297487 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2023-09-21

No results posted yet for this study

Summary

Amyotrophic lateral sclerosis (ALS) is a rare and serious neurodegenerative disease causing degeneration of motor neurons. . It leads to a progressive paralysis of the muscles involved in voluntary motricity. In France, its incidence is 2.5/100,000 inhabitants per year.

The death of patients is mainly caused by a progressive attack of the respiratory muscles. Indeed, the thorax is no longer actively mobilized to the maximum amplitude, it will lose its flexibility. A restrictive syndrome sets in followed by alveolar hypoventilation. Bronchial congestion may be concomitant.

Management is then based on non-invasive ventilation (NIV). This step, which is difficult for patients to accept psychologically, must be delayed as much as possible. However, to date, there are no precise recommendations on preventing the appearance of this restrictive syndrome and on slowing down the deterioration of lung function in patients.

The pressure relaxer (RLX) is an instrumental aid allowing on the one hand to mobilize the thorax thanks to hyper insufflations, and on the other hand to increase the effectiveness of the cough. The use of this device in physiotherapy is part of the HAS recommendations to promote decluttering.

However, we believe that RLX in patients with ALS, through the pulmonary alveolar recruitment it induces, could be relevant at an earlier phase, for the prevention of the decline in pulmonary functions: the restrictive syndrome, bronchial congestion and alveolar hypoventilation. So ultimately, the quality of life and survival of these patients would be improved.

It is in this context that this multicenter randomized controlled study RELAX'SLA takes place in order to evaluate the effects of the early use of the pressure relaxer on the respiratory impairment of patients with ALS.

Conditions

Interventions

DEVICE

early use of intermittent positive pressure breathing

standard care associated with daily and early use of intermittent positive pressure breathing

Sponsors & Collaborators

  • Centre Hospitalier Universitaire de la Réunion

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-01
Primary Completion
2028-07-01
Completion
2028-07-01

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05297487 on ClinicalTrials.gov