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NCT04652401 Clinical Trial

Quality of Life in Ventilator-dependant Neuromuscular Patients

Quality of Life Clinical Trial

— EqualVENT  

Official title:
Assessment of Quality of Life and Its Determinants in Ventilator-dependent Patients With Slowly Progressive Neuromuscular Disease

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04652401
Other study ID # 2020-A00997-32
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 2, 2020
Est. completion date December 7, 2021

Study information
Verified date February 2022
Source Centre d'Investigation Clinique et Technologique 805
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study aims at evaluating the quality of life of patients with slowly progressive neuromuscular disorders who are dependant on mechanical ventilation (daily usage ≥ 16h).

Recruitment information / eligibility
Status Completed
Enrollment 119
Est. completion date December 7, 2021
Est. primary completion date December 7, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients with slowly progressive neuromuscular disorder (NMD), non walking - Patients dependant on mechanical ventilation (daily usage = 16h) for at least 1 year before inclusion - Aged = 18 yo - Consent for participation - Affiliated to a social security regime Exclusion Criteria: - Patients with medically non-stable NMD: fever, acute respiratory infection, organ decompensation - Patients with significant cognitive impairment (inability to read and/or incomprehension of questions) - Patients with fast-evolving neuromuscular disease - Patients declining to participate in the study - Patients under guardianship and/or trusteeship - Pregnant women

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
France AFM Téléthon Évry

Sponsors (4)
Lead Sponsor Collaborator
Centre d'Investigation Clinique et Technologique 805 AFM Téléthon, FilNeMus, Fondation Garches

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Score of the Severe Respiratory Insufficiency questionnaire (SRI) Higher score represents better quality of life 1 Day
Primary Score of the Quality of Life Measure for people with slowly progressive and genetic neuromuscular disease questionnaire (QoL-gNMD) Higher score represents better quality of life 1 Day
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