Prevalence of Nocturnal Hypoventilation in Neuromuscular Diseases According to Different Definitions

Completed

• Conditions: Neuromuscular Disease

• Registration Number: NCT02356666
• Lead Sponsor: Centre d'Investigation Clinique et Technologique 805

Brief Summary

Different definitions of nocturnal hypoventilation are used in the recent literature. The investigators aimed to compare the prevalence of nocturnal hypoventilation in a neuromuscular disease's population according to different definitions issued from the literature.

Detailed Description

Different definitions of nocturnal hypoventilation are used in the recent literature. Basing on retrospective data review, we aimed to compare the prevalence of nocturnal hypoventilation in the cohort of neuromuscular disease's patients followed at our reference center, according to different definitions issued from the literature.

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2014-12-17
• Study First Submitted QC: 2015-02-04
• Study First Posted: 2015-02-05
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-25
• Last Update Posted: 2016-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 232

Inclusion Criteria

• Neuromuscular disease
• Age ≥18 years
• Non mechanically ventilated

Exclusion Criteria

• Long-term oxygen therapy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Differences in the prevalence of nocturnal hypoventilation according to different previously proposed definitions	Baseline (Day 1)	The prevalence of nocturnal hypoventilation (percentage of patients diagnosed as having hypoventilation over the total population) according to the different definition available in the literature will be described

Secondary Outcome Measures

Name	Time	Method
Concordance between the diagnostic criteria	Baseline (Day 1)	Concordance between the different diagnostic criteria of hypoventilation
sensibility/specificity of the different criteria to identify daytime alveolar hypoventilation (defined on blood gas analysis)	Baseine (Day 1)	sensibility/specificity of the different criteria to identify daytime alveolar hypoventilation (defined on blood gas analysis)
Prognostic value of the different definitions of nocturnal hypoventilation	5 years	The ability of the examined definition to predict the need for mechanical ventilation will be investigated, defined as appearance of daytime hypercapnia or beginning of mechanical ventilation and/or mortality.

Trial Locations

Locations (1)

Hopital Raymond Poincare; 🇫🇷 Garches, France