Clinical trial NCT03861468: Medico-economics and QoL of Obese Patients Followed by Medical Analysis Laboratories (BIOSAOS )
Official title: Medico-economic and Quality of Life Evaluations in Obese Patients Followed by Medical Analysis Laboratories
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Obesity Hypoventilation Syndrome
Obstructive Sleep Apnea
Keywords: obesity hypoventilation syndrome
obstructive sleep apnea
bicarbonates
STOP-BANG
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: University Hospital, Angers
name: Poitiers University Hospital
name: Union hospital, Toulouse
name: Hospital Alpes Leman, Annemasse
name: Hospital La Louvière, Lille
name: Oriade Laboratory, Vizille
name: Cerballiance laboratories, Lille
name: Oriade laboratory, Annemasse
First posted: 2019-03-04
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Open, controlled, randomized clinical trial (cluster randomization)
Primary purpose: SCREENING

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.

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)

Primary outcomes:
measure: 2-year medico-economic impact of the implementation of early care in obese patients with OSA
timeFrame: 24 months
Secondary outcomes:
measure: Economic impact of the implementation of early care in obese patients with OSA over 3 years on the healthcare costs
timeFrame: 3 years
measure: To evaluate the sensitivity of the screening tool
timeFrame: 24 months
measure: To evaluate the specificity of the screening tool
timeFrame: 24 months
measure: To evaluate the negative Predictive Value
timeFrame: 24 months
measure: To evaluate the positive predictive value of the screening tool
timeFrame: 24 months
measure: Clinical impact of the early care pathway on blood pressure at 12 months
timeFrame: 12 months
measure: Clinical impact of the early care pathway on blood pressure at 24 months
timeFrame: 24 months
measure: Clinical impact of the early care pathway on quality of life at 12 months
timeFrame: 12 months
measure: Clinical impact of the early care pathway on quality of life at 24 months
timeFrame: 24 months
measure: Clinical impact of the early care pathway (early care) on quality of life at 12 months
timeFrame: 12 months
measure: Clinical impact of the early care pathway (early care) on quality of life at 24 months
timeFrame: 24 months
measure: Clinical impact of the early care pathway on pharmacological treatments at 12 months
timeFrame: 12 months
measure: Clinical impact of the early care pathway on pharmacological treatments at 24 months
timeFrame: 24 months
measure: Impact on laboratory test results (troponin) at 12 months
timeFrame: 12 months
measure: Impact on laboratory test results (troponin) at 24 months
timeFrame: 24 months
measure: Impact on laboratory test results (NT-proBNP) at 12 months
timeFrame: 12 months
measure: Impact on laboratory test results (NT-proBNP) at 24 months
timeFrame: 24 months
measure: Impact on laboratory test results on cholesterol at 12 months
timeFrame: 12 months
measure: Impact on laboratory test results on cholesterol at 24 months
timeFrame: 24 months
measure: Impact on laboratory test results on triglycerides at 12 months
timeFrame: 12 months
measure: Impact on laboratory test results on triglycerides at 24 months
timeFrame: 24 months
measure: Impact on laboratory test results on glycaemia at 12 months
timeFrame: 12 months
measure: Impact on laboratory test results on glycaemia at 24 months
timeFrame: 24 months
measure: Impact on laboratory test results on Homeostasis model assessment (HOMA)-index at 12 months
timeFrame: 12 months
measure: Impact on laboratory test results on Homeostasis model assessment (HOMA)-index at 24 months
timeFrame: 24 months
measure: Impact on laboratory test results on hepatic transaminases at 12 months
timeFrame: 12 months
measure: Impact on laboratory test results on hepatic transaminases at 24 months
timeFrame: 24 months
measure: Impact on laboratory test results on creatinine at 12 months
timeFrame: 12 months
measure: Impact on laboratory test results on creatinine at 24 months
timeFrame: 24 months
measure: Impact on laboratory test results on C-Reactive Protein (CRP) at 12 months
timeFrame: 12 months
measure: Impact on laboratory test results on C-Reactive Protein (CRP) at 24 months
timeFrame: 24 months
measure: Impact on laboratory test results on alpha2-macroglobulin at 12 months
timeFrame: 12 months
measure: Impact on laboratory test results on alpha2-macroglobulin at 24 months
timeFrame: 24 months
Other outcomes:
Locations:
city: Vizille
country: France
facility: ORIADE
Study officials:
affiliation: Grenoble Alpes University Hospital
name: Jean-Louis PEPIN, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: