Prevalence of Obesity Hypoventilation Syndrome (BIO-OHS)

AGIR à Dom

Status: Completed

Conditions: Obesity Hypoventilation Syndrome

Treatments: Procedure: Blood test analysis in the clinical labs; Procedure: Pneumologist consult to establish the diagnosis of OHS

Study type: Interventional

Funder types: Other

Identifiers

NCT01903135

13-AGIR-02

2013-A00744-41 (Other Identifier)

Details and patient eligibility

About

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.

Full description

No additional description

Enrollment: 1,004 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

1,004 participants in 3 patient groups

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

Other group

Description:

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

Treatment:

Procedure: Blood test analysis in the clinical labs

Procedure: Pneumologist consult to establish the diagnosis of OHS

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

Other group

Description:

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.

Treatment:

Procedure: Blood test analysis in the clinical labs

Procedure: Pneumologist consult to establish the diagnosis of OHS

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

Other group

Description:

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

Treatment:

Procedure: Blood test analysis in the clinical labs