Clinical Trial: Prevalence of Obesity Hypoventilation Syndrome

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Prevalence of Obesity Hypoventilation Syndrome in Subjects With Obesity Referred to Clinical (Medical Analysis) Laboratories for Regular Follow-up

Brief Summary:

Rationale of the "BIO-OHS" study (Prevalence of Obesity Hypoventilation Syndrome):

The overall prevalence of Obesity Hypoventilation Syndrome (OHS) has never been directly assessed in the general population. Actually, this prevalence has been assessed in patients referred to sleep clinics with a potential diagnosis of sleep-disordered breathing or in patients already diagnosed with sleep apnea. The purpose of this study is to determine the prevalence of Obesity Hypoventilation syndrome in obese patients referred to clinical laboratories for regular follow-up medical analysis.


Detailed Summary: No additional description
Sponsor: AGIR à Dom

Current Primary Outcome: Prevalence of Obesity Hypoventilation Syndrome (OHS) in obese subjects referred to clinical laboratories for regular blood test analysis. [ Time Frame: From date of inclusion until the end of the study currently planned (up to 2 years) ]

OHS prevalence, validated by arterial blood gases analysis, will be assessed by the percentage of patients with OHS among all patients included in the study


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Sensitivity and specificity of plasmatic [HCO3-] to detect OHS [ Time Frame: From date of inclusion to the end of the study currently planned (2 years) ]

    A ROC curve will determine if the threshold of 27 mmol/L has the best diagnostic value.

    Decision trees will show if the diagnostic value of plasmatic [HCO3-]could be optimized by a combination with other clinical parameters.

  • Prevalence of metabolic and cardiovascular comorbidities in patients with OHS [ Time Frame: From date of inclusion to the end of the study currently planned (2 years) ]
    Prevalence will be estimated by the percentage and the confidence interval. Prevalences of metabolic and cardiovascular comorbidities among patients with OHS and without OHS will be compared by a KHI-2 test or Fisher Exact depends on the theorical number.
  • To determine which medical specialties referred patients with OHS to clinical labs [ Time Frame: From date of inclusion to the end of the study currently planned (2 years) ]
    estimated by percentage
  • Incidence of serious health events at 1 and 2-year follow-up [ Time Frame: From time of OHS diagnostic to 1 and 2-year follow-up ]
    Cardiovascular, metabolic and respiratory events (measured by percentages in OHS group and non-OHS group) will be compared by logistic regressions.


Original Secondary Outcome: Same as current

Information By: AGIR à Dom

Dates:
Date Received: July 16, 2013
Date Started: September 2013
Date Completion:
Last Updated: January 31, 2017
Last Verified: March 2015