Study Purpose:
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.Study Status:
Recruiting
Disease:
Amyotrophic Lateral Sclerosis , Noninvasive Ventilation
Study Type:
Interventional
Type of Intervention:
N/A
Intervention Name:
teleconsultation
Placebo:
Phase:
N/A
Study Chair(s)/Principal Investigator(s):
Sandrine Pontier-Marchandise, MD, University Hopsital Toulouse
Clinicaltrials.gov ID:
Neals Affiliated?
No
Coordinating Center Contact Information
Sandrine Pontier-Marchandise, MD / email hidden; JavaScript is required / 05 67 77 18 46
Full Study Summary:
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.
Study Sponsor:
University Hospital, Toulouse
Estimated Enrollment:
33
Estimated Study Start Date:
04 / 12 / 2021
Estimated Study Completion Date:
02 / 29 / 2024
Posting Last Modified Date:
07 / 29 / 2022
Date Study Added to neals.org:
03 / 15 / 2021
Minimum Age:
18 Years
Maximum Age:
N/A
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
o exclusion criteria:
- Patient with another cause of chronic respiratory failure: other neuromuscular diseases, Chronic obstructive pulmonary disease (COPD), diffuse interstitial lung disease,
- Patient under guardianship or under judicial protection,
- Patient dependent at least 20 hours out of 24 of the non invasive Ventilation (NIV).
Toulouse University Hospital | Recruiting
Sandrine Pontier-Marchandise, Dr / 05 67 77 18 46 / email hidden; JavaScript is required
Toulouse
France