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

  • France
      • Garches, France, 92380
        • Hôpital Raymond Poincaré

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.

Sponsor

Centre d'Investigation Clinique et Technologique 805

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.

Clinical Trials on Neuromuscular Disease

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Zambia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe