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EqualVENT: Quality of Life in Ventilator-dependant Neuromuscular Patients

Sponsor
Centre d'Investigation Clinique et Technologique 805 (Other)
Overall Status
Completed
CT.gov ID
NCT04652401
Collaborator
Fondation Garches (Other), AFM Téléthon (Other), FilNeMus (Other)
119
Enrollment
1
Location
12.2
Actual Duration (Months)
9.8
Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    119 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    Assessment of Quality of Life and Its Determinants in Ventilator-dependent Patients With Slowly Progressive Neuromuscular Disease
    Actual Study Start Date :
    Dec 2, 2020
    Actual Primary Completion Date :
    Dec 7, 2021
    Actual Study Completion Date :
    Dec 7, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Score of the Severe Respiratory Insufficiency questionnaire (SRI) [1 Day]

      Higher score represents better quality of life

    2. Score of the Quality of Life Measure for people with slowly progressive and genetic neuromuscular disease questionnaire (QoL-gNMD) [1 Day]

      Higher score represents better quality of life

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 AFM Téléthon Évry France

    Sponsors and Collaborators

    • Centre d'Investigation Clinique et Technologique 805
    • Fondation Garches
    • AFM Téléthon
    • FilNeMus

    Investigators

    • Principal Investigator: Mathieu Delorme, MSc, Université Paris-Saclay, UVSQ, ERPHAN, 78000, Versailles, FRANCE
    • Study Director: Frederic Lofaso, MD, PhD, Université Paris-Saclay, UVSQ, ERPHAN, 78000, Versailles, FRANCE

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Centre d'Investigation Clinique et Technologique 805
    ClinicalTrials.gov Identifier:
    NCT04652401
    Other Study ID Numbers:
    • 2020-A00997-32
    First Posted:
    Dec 3, 2020
    Last Update Posted:
    Feb 9, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Neuromuscular Diseases

    Study Results

    No Results Posted as of Feb 9, 2022