Patient's TeleMonitoring With Amyotrophic Lateral Sclerosis Treated by Non Invasive Ventilation at Home.

Last updated: June 14, 2024
Sponsor: University Hospital, Toulouse
Overall Status: Completed

Phase

N/A

Condition

Amyotrophic Lateral Sclerosis (Als)

Myasthenia Gravis (Chronic Weakness)

Scar Tissue

Treatment

teleconsultation

Clinical Study ID

NCT04797845
RC31/20/0477
  • Ages > 18
  • All Genders

Study Summary

Single-center, prospective pilot study on patients with amyotrophic lateral sclerosis fitted with noninvasive ventilation. The objective is to assess the satisfaction of remote monitoring of patients on non-invasive ventilation after 12 months.

Eligibility Criteria

Inclusion

o inclusion criteria:

  • Patient over 18 years,

  • Patient with Amyotrophic Lateral Sclerosis (ALS),

  • Already fitted by Non Invasive Ventilation (NIV),

  • Patient having signed the informed consent

  • Patient affiliated to a social security scheme,

  • Patient with a correct understanding of the French language,

  • Patient with access to an internet connection at home.

For the caregiver:

  • Adult person

  • Be the patient's primary caregiver

  • Have signed the informed consent intended for the caregiver

Exclusion

o exclusion criteria:

  • Patient with another cause of chronic respiratory failure: other neuromusculardiseases, Chronic obstructive pulmonary disease (COPD), diffuse interstitial lungdisease,

  • Patient under guardianship or under judicial protection,

  • Patient dependent at least 20 hours out of 24 of the non invasive Ventilation (NIV).

Study Design

Total Participants: 33
Treatment Group(s): 1
Primary Treatment: teleconsultation
Phase:
Study Start date:
April 12, 2021
Estimated Completion Date:
September 18, 2023

Study Description

The non invasive ventilation is one of treatments used during the amyotrophic lateral sclerosis when patients have a chronic respiratory failure with alveolar hypoventilation signs. It is demonstrated to improve quality of life and prognosis of the disease. These patients, often severely disabled, generally have a negative experience of repeated hospitalizations. Despite everything, medical and paramedical monitoring is necessary, especially when they are fitted with non invasive ventilation (NIV). A quarterly reassessment is recommended . The possibilities of telemonitoring at home have grown considerably in recent years. In addition, the fans are currently able to remotely transfer a certain amount of data to the service provider, making remote monitoring feasible.Our project therefore aims to assess the feasibility of remote monitoring of patients with Amyotrophic Lateral Sclerosis (ALS) fitted with non invasive ventilation (NIV) through the assessment of their satisfaction, using both medical data and data provided by the ventilator. It is a single-center, prospective pilot study on 30 patients with amyotrophic lateral sclerosis fitted with noninvasive ventilation. Patients will benefit from a quarterly teleconsultation to assess the study criteria through questionnaires during 12 months. Ventilation machines make it possible to carry out remote monitoring, with the help of healthcare providers.

Connect with a study center

  • Toulouse University Hospital

    Toulouse,
    France

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.