Prevalence of Obesity Hypoventilation Syndrome (BIO-OHS)

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity Hypoventilation Syndrome
• Intervention / Treatment: Procedure: Blood test analysis in the clinical labs; Procedure: Pneumologist consult to establish the diagnosis of OHS

Detailed Description

No additional description

• Study Type: Interventional
• Enrollment (Actual): 1004
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: [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	Procedure: Blood test analysis in the clinical labs; for specific measurement of plasmatic bicarbonate; 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.
Other: [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.	Procedure: Blood test analysis in the clinical labs; for specific measurement of plasmatic bicarbonate; 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.
Other: [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)	Procedure: Blood test analysis in the clinical labs; for specific measurement of plasmatic bicarbonate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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

Collaborators and Investigators

• Sponsor: AGIR à Dom

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Actual): February 1, 2015
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: July 16, 2013
• First Submitted That Met QC Criteria: July 18, 2013
• First Posted (Estimate): July 19, 2013

Study Record Updates

• Last Update Posted (Estimate): February 1, 2017
• Last Update Submitted That Met QC Criteria: January 31, 2017
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: Prevalence; Obesity Hypoventilation Syndrome; Bicarbonate
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Disease; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Respiratory Insufficiency; Sleep Apnea, Obstructive; Syndrome; Obesity; Hypoventilation; Obesity Hypoventilation Syndrome
• Other Study ID Numbers: 13-AGIR-02; 2013-A00744-41 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED