Obesity Hypoventilation Syndrome Clinical Trial
— BIO-OHSOfficial title:
Prevalence of Obesity Hypoventilation Syndrome in Subjects With Obesity Referred to Clinical (Medical Analysis) Laboratories for Regular Follow-up
Verified date | March 2015 |
Source | AGIR à Dom |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
AGIR à Dom |
France,
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 |
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