Prevalence of Obesity Hypoventilation Syndrome

N/ACompletedNCT01903135

AGIR à Dom1,004 enrolled

Overview

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.

No additional description

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

1,004

Conditions

Obesity Hypoventilation Syndrome

Interventions

Blood test analysis in the clinical labsPROCEDURE

for specific measurement of plasmatic bicarbonate

Pneumologist consult to establish the diagnosis of OHSPROCEDURE

complete respiratory check-up: Arterial blood gases analysis, spirometry, anthropometry, polygraphy or polysomnography. Medical history, previous treatments.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 18 years old ans more * BMI over 30 kg/M2 * Stable state (respiratory, metabolic and cardio-vascular) for the last 2 months * Addressed to a clinical labs for a blood check-up whatever the prescription Exclusion Criteria: * No social security * Non cooperative patient, as judged by the investigator

Locations (5)

Cabinet de Pneumologie Grenoble SUD

Échirolles, France

Laboratoire MEDIBIO Les Cedres

Échirolles, France

Hôpital Michallon, Laboratoire EFCR et Sommeil

Grenoble, France

Cabinet de Pneumologie Perpignan

Perpignan, France

Outcomes

Primary Outcomes

Prevalence of Obesity Hypoventilation Syndrome (OHS) in obese subjects referred to clinical laboratories for regular blood test analysis.

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

Time frame: From date of inclusion until the end of the study currently planned (up to 2 years)

Secondary Outcomes

Sensitivity and specificity of plasmatic [HCO3-] to detect OHS

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.

Time frame: From date of inclusion to the end of the study currently planned (2 years)

Prevalence of metabolic and cardiovascular comorbidities in patients with OHS

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.

Time frame: From date of inclusion to the end of the study currently planned (2 years)

To determine which medical specialties referred patients with OHS to clinical labs

estimated by percentage

Time frame: From date of inclusion to the end of the study currently planned (2 years)

Incidence of serious health events at 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.

Time frame: From time of OHS diagnostic to 1 and 2-year follow-up

Data from ClinicalTrials.gov

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