Prevalence of Nocturnal Hypoventilation in Neuromuscular Diseases According to Different Definitions

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02356666

Acronym

TcCO2

Enrollment

232

Registered

2015-02-05

Start date

2014-12-31

Completion date

2015-11-30

Last updated

2016-02-26

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

Conditions

Neuromuscular Disease

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* Long-term oxygen therapy

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

France

Outcome results