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

  • STATUS
    Recruiting
  • End date
    Sep 14, 2023
  • participants needed
    338
  • sponsor
    University Hospital, Grenoble
Updated on 19 February 2022
bang
apnea
respiratory disorder
respiratory disease
blood bicarbonate

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.

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.

Details
Condition Obesity Hypoventilation Syndrome, Obstructive Sleep Apnea
Treatment Care pathway, Care pathway
Clinical Study IdentifierNCT03861468
SponsorUniversity Hospital, Grenoble
Last Modified on19 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients aged from 18 to 80 years
Obese (BMI 30kg/m)
Referred by GPs to the medical analysis laboratory for usual biological assessment
Patients with no respiratory follow-up already in place
Bicarbonate - Concentration 27 mmol/L
Patient affiliated with a social protection plan
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
Patients already included in an interventional study (end of the study < 1 month)
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)
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