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OpenTrials
Completed

NCT Number: NCT02356666

Prevalence of Nocturnal Hypoventilation in Neuromuscular Diseases According to Different Definitions

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.

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Key information

Conditions

Neuromuscular Disease Nervous System Diseases Neuromuscular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hopital Raymond Poincare

Garches, 92380, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Long-term oxygen therapy

Treatment and study plan

Primary outcomes

  1. Differences in the prevalence of nocturnal hypoventilation according to different previously proposed definitions

    Time frame: 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 outcomes

  1. Concordance between the diagnostic criteria

    Time frame: Baseline (Day 1)

    Concordance between the different diagnostic criteria of hypoventilation

  2. sensibility/specificity of the different criteria to identify daytime alveolar hypoventilation (defined on blood gas analysis)

    Time frame: Baseine (Day 1)

    sensibility/specificity of the different criteria to identify daytime alveolar hypoventilation (defined on blood gas analysis)

  3. Prognostic value of the different definitions of nocturnal hypoventilation

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Centre d'Investigation Clinique et Technologique 805

Other

Registry information

Acronym: TcCO2

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Feb 5, 2015
Registry last updated
Feb 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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