Medico-economics and QoL of Obese Patients Followed by Medical Analysis Laboratories (BIOSAOS )

NCT ID: NCT03861468

Last Updated: 2023-01-05

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-14
• Study Completion Date: 2022-12-06

Brief Summary

Obesity is a major risk factor for obstructive sleep apnea (OSA). However, OSA is still largely under diagnosed in patients with a high cardiovascular risk. In this population the STOP-BANG questionnaire facilitates OSA screening. Moreover, blood bicarbonate concentration is a simple tool to screen for chronic respiratory disease and if elevated, is a marker of cardiometabolic comorbidities in obese patients. A combination of blood bicarbonate concentration and STOP BANG score could provide a cost-effective method of screening for OSA in obese patients. Such screening could enable earlier management and might significantly reduce the costs of treatment and improve the quality of life of patients at 2 years.

Detailed Description

OSA is a frequent condition in the general population (3% of women and 10% of men), but remains largely undiagnosed. Obesity is a risk factor for OSA. Sleep apnea is associated with diurnal and nocturnal symptoms (snoring, somnolence, fatigue), and with increased cardiometabolic morbidity and mortality. Currently, continuous positive airway pressure (CPAP) is the gold-standard treatment for OSA and the cost-effectiveness of this treatment has already been demonstrated. Easy-to-use procedures to identify OSA patients earlier and thus to initiate treatment earlier, need to be developed and validated. The STOP-BANG questionnaire has been designed to facilitate the screening of OSA patients. Moreover, a measure of blood bicarbonate concentration is a simple method for screening for chronic respiratory diseases and a marker of cardiometabolic comorbidities. A combination of blood bicarbonate measurement and STOP-BANG score could permit earlier screening and less expensive care of obese patients. The hypothesize is that such OSA screening in the obese population (bicarbonates + STOPBANG) associated with earlier care (with treatment if necessary) could lead to improvement in quality of life of obese patients at 2 years.

Conditions

Obesity Hypoventilation Syndrome; Obstructive Sleep Apnea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Usual care

Patients in the usual care group will be referred to their general practitioner (GP) / primary care practitioner as usual.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Early care

A different care pathway will be followed by the patients randomized to this group. They will be referred to a specialist (pneumologist) for OSA diagnosis and treatment if necessary

Group Type: ACTIVE_COMPARATOR

Care pathway

Intervention Type: OTHER

Screening for OSA using a combination of bicarbonate assay and STOP-BANG questionnaire and further management by a pneumologist as necessary

Interventions

Care pathway

Screening for OSA using a combination of bicarbonate assay and STOP-BANG questionnaire and further management by a pneumologist as necessary

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients aged from 18 to 80 years
• Obese (BMI ≥ 30kg/m²)
• Referred by GPs to the medical analysis laboratory for usual biological assessment
• Patients with no respiratory follow-up already in place
• Patient affiliated with a social protection plan
• Bicarbonate - Concentration ≥ 27 mmol/L
• STOP-BANG score ≥ 3
• Informed written consent signed by the patient

Exclusion Criteria

• Acute disease or recently diagnosed chronic disease (< 2 months)
• Hospitalization for respiratory, metabolic or cardiovascular event (< 2 months)
• Renal insufficiency stage 4 or 5, or autoimmune disease, or viral hepatitis, or cirrhosis
• Cited persons in Sections L1121-5 to L1121-8 of the CSP (pregnant woman, parturient, nursing mother, person deprived of liberty by judicial or administrative decision, a person who is the subject of a judicial or administrative legal protection)
• Patients already included in an interventional study (end of the study < 1 month)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Angers

OTHER_GOV

Sponsor Role: collaborator

Poitiers University Hospital

OTHER

Sponsor Role: collaborator

Union hospital, Toulouse

UNKNOWN

Sponsor Role: collaborator

Hospital Alpes Leman, Annemasse

UNKNOWN

Sponsor Role: collaborator

Hospital La Louvière, Lille

UNKNOWN

Sponsor Role: collaborator

Oriade Laboratory, Vizille

UNKNOWN

Sponsor Role: collaborator

Cerballiance laboratories, Lille

UNKNOWN

Sponsor Role: collaborator

Oriade laboratory, Annemasse

UNKNOWN

Sponsor Role: collaborator

University Hospital, Grenoble

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean-Louis PEPIN, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Grenoble Alpes University Hospital

Locations

ORIADE

Vizille, , France

Countries

France

Other Identifiers

38RC17.360

Identifier Type: -

Identifier Source: org_study_id