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

Grenoble Alpes University Hospital Center (CHU)

Status: Withdrawn

Conditions: Obstructive Sleep Apnea; Obesity Hypoventilation Syndrome

Treatments: Other: Care pathway

Study type: Interventional

Funder types: Other

Identifiers

NCT03861468

38RC17.360

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Usual care

No Intervention group

Description:

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

Early care

Active Comparator group

Description:

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

Treatment:

Other: Care pathway