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Trial record 15 of 5221 for:    neuromuscular disease

Prevalence of Nocturnal Hypoventilation in Neuromuscular Diseases According to Different Definitions (TcCO2)

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ClinicalTrials.gov Identifier: NCT02356666
Recruitment Status : Completed
First Posted : February 5, 2015
Last Update Posted : February 26, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
Neuromuscular Disease

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.

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Study Type : Observational
Actual Enrollment : 232 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Prevalence of Nocturnal Hypoventilation in Neuromuscular Diseases According to Different Definitions
Study Start Date : December 2014
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Neuromuscular disease
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Long-term oxygen therapy

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02356666


Locations
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France
Hopital Raymond Poincare
Garches, France, 92380
Sponsors and Collaborators
Centre d'Investigation Clinique et Technologique 805
Investigators
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Principal Investigator: Adam Ogna, PhD Assistance Publique - Hôpitaux de Paris

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Responsible Party: Centre d'Investigation Clinique et Technologique 805
ClinicalTrials.gov Identifier: NCT02356666     History of Changes
Other Study ID Numbers: 1817118
First Posted: February 5, 2015    Key Record Dates
Last Update Posted: February 26, 2016
Last Verified: February 2016
Additional relevant MeSH terms:
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Hypoventilation
Neuromuscular Diseases
Nervous System Diseases
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms