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Amyotrophic Lateral Sclerosis Non-invasive Ventilation Exchange

Amyotrophic Lateral Sclerosis Non-invasive Ventilation Exchange

Recruiting
30-85 years
All
Phase N/A

Overview

The median survival of patients with amyotrophic lateral sclerosis (ALS) is 3 to 5 years and mortality is mainly related to respiratory failure. Non-invasive ventilation (NIV) and multidisciplinary management improve the quality of life and survival of patients. However, patients have mobility difficulties related to the progressive worsening of functional disabilities. The research team hypothesize that the use of a multimodal digital platform, including in particular telemonitoring of NIV and teleconsultation, will slow down the evolution of the disabilities of patients with ALS and improve their quality of life.

Description

Amyotrophic lateral sclerosis (ALS) is a progressive neurodegenerative disease with a median life expectancy of 3 to 5 years. Respiratory failure due to alveolar hypoventilation is the main cause of mortality and respiratory impairment leads to a significant deterioration in quality of life.

Non-invasive ventilation (NIV) improves patient quality of life, improves gas exchange and improves patient survival. NIV should be initiated early, based on symptomatology and lung function, and monitored closely to adjust device parameters. NIV is a complex intervention that must be individualized for each patient.

In addition, multidisciplinary management involving different healthcare professionals, keeping the patient and caregivers at the center of the network, also allows for an improvement in the quality of life and survival of these patients.

However, patients with ALS have difficulty moving around and access to care becomes more complicated as the disease progresses. This phenomenon was increased during the COVID- 19 pandemic with a more rapid functional decline.

The development of new technologies should make it possible to rethink patient management, in particular through remote monitoring of NIV devices, teleconsultation, administration of questionnaires and better interprofessional organization. Several studies have confirmed the feasibility and acceptance of telemedicine solutions in this population.

In this project, The research team hypothesize that the use of a multimodal digital platform will slow the progression of disability in ALS patients and improve their quality of life, in particular by improving the quality of NIV and optimizing the coordination of a multidisciplinary team.

Eligibility

Inclusion Criteria:

  • Patients between 30 and 85 years old
  • Diagnosis of ALS
  • Indication and acceptance of non-invasive ventilation
  • Patient equipped with suitable equipment (tablet, computer, telephone, etc.) with an internet connection at home
  • Patient able to read and understand the procedure, and able to express consent for the study protocol

Exclusion Criteria:

  • Treatment with non-invasive ventilation in the previous three months
  • Refusal/inability to use a smart phone or digital device
  • Patient currently participating or having participated in the month preceding inclusion in another clinical interventional research that could impact the study, this impact is left to the discretion of the investigator.
  • Subject under guardianship or curators
  • Subject not affiliated to a social security scheme, or not a beneficiary of such a scheme.
  • Subject deprived of liberty by judicial or administrative decision
  • Pregnant, parturient, breastfeeding women
  • Refusal to give consent

Study details
    Amyotrophic Lateral Sclerosis

NCT05837507

University Hospital, Montpellier

24 January 2025

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