Prevalence of Nocturnal Hypoventilation in Neuromuscular Diseases According to Different Definitions

Neuromuscular Disease Clinical Trial

— TcCO2  

Official title:

Prevalence of Nocturnal Hypoventilation in Neuromuscular Diseases According to Different Definitions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02356666
• Other study ID #: 1817118
• Status: Completed
• Phase: N/A
• First received: December 17, 2014
• Last updated: February 25, 2016
• Start date: December 2014
• Est. completion date: November 2015

Study information

• Verified date: February 2016
• Source: Centre d'Investigation Clinique et Technologique 805
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: The Commission nationale de l’informatique et des libertés
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 232
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Neuromuscular disease

• Age =18 years

• Non mechanically ventilated

Exclusion Criteria:

• Long-term oxygen therapy

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Hypoventilation
• Neuromuscular Disease
• Neuromuscular Diseases

Locations

Country	Name	City	State
France	Hopital Raymond Poincare	Garches

Sponsors (1)

Lead Sponsor	Collaborator
Centre d'Investigation Clinique et Technologique 805

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differences in the prevalence of nocturnal hypoventilation according to different previously proposed definitions	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	Baseline (Day 1)	No
Secondary	Concordance between the diagnostic criteria	Concordance between the different diagnostic criteria of hypoventilation	Baseline (Day 1)	No
Secondary	sensibility/specificity of the different criteria to identify daytime alveolar hypoventilation (defined on blood gas analysis)	sensibility/specificity of the different criteria to identify daytime alveolar hypoventilation (defined on blood gas analysis)	Baseine (Day 1)	No
Secondary	Prognostic value of the different definitions of nocturnal hypoventilation	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.	5 years	No