Quality of Life in Ventilator-dependant Neuromuscular Patients

Completed

• Conditions: Neuromuscular Diseases; Respiration, Artificial; Quality of Life; Noninvasive Ventilation; Tracheostomy

• Registration Number: NCT04652401
• Lead Sponsor: Centre d'Investigation Clinique et Technologique 805

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-11-09
• Study Start: 2020-12-02
• Study First Submitted QC: 2020-12-02
• Study First Posted: 2020-12-03
• Primary Completion: 2021-12-07
• Study Completion: 2021-12-07
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-08
• Last Update Posted: 2022-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 119

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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
Score of the Severe Respiratory Insufficiency questionnaire (SRI)	1 Day	Higher score represents better quality of life

Trial Locations

Locations (1)

AFM Téléthon; 🇫🇷 Évry, France