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Impact of Early Initiation of Non-Invasive Ventilation on Survival, Respiratory Function and Quality of Life in Patients with Neuromuscular Diseases: A Prospective Comparative Study

Impact of Early Initiation of Non-Invasive Ventilation on Survival, Respiratory Function and Quality of Life in Patients with Neuromuscular Diseases: A Prospective Comparative Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
PACTR
Registry ID
PACTR202509592615682
Enrollment
400
Registered
2025-09-25
Start date
2025-09-01
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Musculoskeletal Diseases Nervous System Diseases

Interventions

Late non invasive ventilation

Sponsors

Hedi Chaker University Hospital of Sfax Tunisia
Lead Sponsor

Eligibility

Sex/Gender
All

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

MeasureTime 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

MeasureTime 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

Public ContactSameh Msaad

University of Sfax Faculty of medicine of Sfax Tunisia

pneumo1972@gmail.com21653163977

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026