Prevalence of Obesity Hypoventilation Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1004 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2015-03-31

Brief Summary

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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.

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Detailed Description

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No additional description

Conditions

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Obesity Hypoventilation Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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[HCO3-] >= 27 mmol/L (Group 1)

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

Group Type OTHER

Blood test analysis in the clinical labs

Intervention Type PROCEDURE

for specific measurement of plasmatic bicarbonate

Pneumologist consult to establish the diagnosis of OHS

Intervention Type PROCEDURE

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

Medical history, previous treatments.

[HCO3-]< 27mmol/L+pneumologist (Group 2)

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.

Group Type OTHER

Blood test analysis in the clinical labs

Intervention Type PROCEDURE

for specific measurement of plasmatic bicarbonate

Pneumologist consult to establish the diagnosis of OHS

Intervention Type PROCEDURE

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

Medical history, previous treatments.

[HCO3-]< 27 mmol/L (Group 3)

Obese patients with a \[HCO3-\]\<27 mmol/L randomized to group 3 will receive usual medical follow-up (end of study)

Group Type OTHER

Blood test analysis in the clinical labs

Intervention Type PROCEDURE

for specific measurement of plasmatic bicarbonate

Interventions

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Blood test analysis in the clinical labs

for specific measurement of plasmatic bicarbonate

Intervention Type PROCEDURE

Pneumologist consult to establish the diagnosis of OHS

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

Medical history, previous treatments.

Intervention Type PROCEDURE

Eligibility Criteria

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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