Musculoskeletal Diseases Nervous System Diseases
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Patients will be eligible if they are 10 years or older and have a FVC < 80%, with a recorded FVC = 80% within the previous six months.
Exclusion criteria
Exclusion criteria: Patients will not be eligible for inclusion if they have previously received NIV or continuous positive airway pressure (CPAP) therapy. Additional non-inclusion criteria include significant cognitive impairment that compromises understanding and compliance with study procedures, including the ability to perform technically acceptable pulmonary function tests, severe comorbidities unrelated to the NMDs that are likely to reduce life expectancy, previous respiratory or cardiac diseases associated with impaired spirometry, and a recent acute respiratory exacerbation within the last four weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this study is to determine whether early initiation of NIV, compared with late initiation, improves survival and health-related quality of life in patients with NMDs | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objectives are to examine the impact of NIV initiation timing on respiratory-related hospitalization rates, dyspnea severity, and adherence and tolerance to NIV | — |
Countries
Tunisia
Contacts
University of Sfax Faculty of medicine of Sfax Tunisia