- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02356666
Prevalence of Nocturnal Hypoventilation in Neuromuscular Diseases According to Different Definitions (TcCO2)
February 25, 2016 updated by: Centre d'Investigation Clinique et Technologique 805
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.
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
232
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Garches, France, 92380
- Hôpital Raymond Poincaré
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Neuromuscular disease
Description
Inclusion Criteria:
- Neuromuscular disease
- Age ≥18 years
- Non mechanically ventilated
Exclusion Criteria:
- Long-term oxygen therapy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Baseline (Day 1)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Concordance between the diagnostic criteria
Time Frame: Baseline (Day 1)
|
Concordance between the different diagnostic criteria of hypoventilation
|
Baseline (Day 1)
|
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)
|
Baseine (Day 1)
|
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.
|
5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Adam Ogna, PhD, Assistance Publique - Hôpitaux de Paris
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2014
Primary Completion (Actual)
November 1, 2015
Study Completion (Actual)
November 1, 2015
Study Registration Dates
First Submitted
December 17, 2014
First Submitted That Met QC Criteria
February 4, 2015
First Posted (Estimate)
February 5, 2015
Study Record Updates
Last Update Posted (Estimate)
February 26, 2016
Last Update Submitted That Met QC Criteria
February 25, 2016
Last Verified
February 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1817118
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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