Prevalence of Obesity Hypoventilation Syndrome

Not Applicable

Completed

• Conditions: Obesity Hypoventilation Syndrome
• Interventions: Procedure: Blood test analysis in the clinical labs; Procedure: Pneumologist consult to establish the diagnosis of OHS

• Registration Number: NCT01903135
• Lead Sponsor: AGIR à Dom

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 Description

No additional description

Study Timeline

• Study First Submitted: 2013-07-16
• Study First Submitted QC: 2013-07-18
• Study First Posted: 2013-07-19
• Study Start: 2013-09
• Primary Completion: 2015-02
• Status Verified: 2015-03
• Study Completion: 2015-03
• Last Update Submitted: 2017-01-31
• Last Update Posted: 2017-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1004

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
[HCO3-]< 27 mmol/L (Group 3)	Blood test analysis in the clinical labs	Obese patients with a \[HCO3-\]\<27 mmol/L randomized to group 3 will receive usual medical follow-up (end of study)
[HCO3-]< 27mmol/L+pneumologist (Group 2)	Blood test analysis in the clinical labs	Among obese patients with serum \[HCO3-\]\< 27 mmol/L, 300 randomized patients will be addressed to a pneumologist. The pneumology investigations will refute(or not)the diagnosis of OHS.
[HCO3-] >= 27 mmol/L (Group 1)	Pneumologist consult to establish the diagnosis of OHS	All obese patients with plasmatic\[HCO3-\] \>= 27 mmol/L will be addressed to a pneumologist. The pneumology investigations will establish(or not) the diagnosis of OHS
[HCO3-]< 27mmol/L+pneumologist (Group 2)	Pneumologist consult to establish the diagnosis of OHS	Among obese patients with serum \[HCO3-\]\< 27 mmol/L, 300 randomized patients will be addressed to a pneumologist. The pneumology investigations will refute(or not)the diagnosis of OHS.
[HCO3-] >= 27 mmol/L (Group 1)	Blood test analysis in the clinical labs	All obese patients with plasmatic\[HCO3-\] \>= 27 mmol/L will be addressed to a pneumologist. The pneumology investigations will establish(or not) the diagnosis of OHS

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Sensitivity and specificity of plasmatic [HCO3-] to detect OHS	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	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	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	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.

Trial Locations

Locations (5)

Laboratoire MEDIBIO Les Cedres; 🇫🇷 Echirolles, France

Cabinet de Pneumologie Grenoble SUD; 🇫🇷 Echirolles, France

Hôpital Michallon, Laboratoire EFCR et Sommeil; 🇫🇷 Grenoble, France

Laboratoire d'analyses medicales de Thuir; 🇫🇷 Thuir, France

Cabinet de Pneumologie Perpignan; 🇫🇷 Perpignan, France