Prevalence of Obesity Hypoventilation Syndrome

Obesity Hypoventilation Syndrome Clinical Trial

— BIO-OHS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01903135
• Other study ID #: 13-AGIR-02
• Secondary ID: 2013-A00744-41
• Status: Completed
• Phase: N/A
• First received: July 16, 2013
• Last updated: January 31, 2017
• Start date: September 2013
• Est. completion date: March 2015

Study information

• Verified date: March 2015
• Source: AGIR à Dom
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

No additional description

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1004
• Est. completion date: March 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypoventilation
• Obesity
• Obesity Hypoventilation Syndrome
• Syndrome

Intervention

Procedure:
• Blood test analysis in the clinical labs
for specific measurement of plasmatic bicarbonate
• 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.

Locations

Country	Name	City	State
France	Cabinet de Pneumologie Grenoble SUD	Echirolles
France	Laboratoire MEDIBIO Les Cedres	Echirolles
France	Hôpital Michallon, Laboratoire EFCR et Sommeil	Grenoble
France	Cabinet de Pneumologie Perpignan	Perpignan
France	Laboratoire d'analyses medicales de Thuir	Thuir

Sponsors (1)

Lead Sponsor	Collaborator
AGIR à Dom

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	From date of inclusion until the end of the study currently planned (up to 2 years)
Secondary	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.	From date of inclusion to the end of the study currently planned (2 years)
Secondary	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.	From date of inclusion to the end of the study currently planned (2 years)
Secondary	To determine which medical specialties referred patients with OHS to clinical labs	estimated by percentage	From date of inclusion to the end of the study currently planned (2 years)
Secondary	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.	From time of OHS diagnostic to 1 and 2-year follow-up