Medico-economic and Quality of Life Evaluations in Obese Patients Followed by Medical Analysis Laboratories
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Locations
- 1
- Primary Endpoint
- 2-year medico-economic impact of the implementation of early care in obese patients with OSA
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Screening
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Outcomes
Primary Outcomes
2-year medico-economic impact of the implementation of early care in obese patients with OSA
Time Frame: 24 months
incremental cost-effectiveness ratio at 24 months calculated from the difference in healthcare costs between the 2 groups (early care vs usual care) adjusted to the difference in the number of quality adjusted life years
Secondary Outcomes
- Impact on laboratory test results on glycaemia at 24 months(24 months)
- Impact on laboratory test results (troponin) at 12 months(12 months)
- Impact on laboratory test results (troponin) at 24 months(24 months)
- Impact on laboratory test results on triglycerides at 12 months(12 months)
- Clinical impact of the early care pathway on quality of life at 12 months(12 months)
- Clinical impact of the early care pathway on quality of life at 24 months(24 months)
- Clinical impact of the early care pathway on pharmacological treatments at 12 months(12 months)
- Economic impact of the implementation of early care in obese patients with OSA over 3 years on the healthcare costs(3 years)
- To evaluate the negative Predictive Value(24 months)
- To evaluate the positive predictive value of the screening tool(24 months)
- Clinical impact of the early care pathway on blood pressure at 12 months(12 months)
- Impact on laboratory test results (NT-proBNP) at 12 months(12 months)
- Impact on laboratory test results (NT-proBNP) at 24 months(24 months)
- Impact on laboratory test results on cholesterol at 24 months(24 months)
- Impact on laboratory test results on Homeostasis model assessment (HOMA)-index at 24 months(24 months)
- Impact on laboratory test results on hepatic transaminases at 12 months(12 months)
- Impact on laboratory test results on alpha2-macroglobulin at 24 months(24 months)
- To evaluate the sensitivity of the screening tool(24 months)
- To evaluate the specificity of the screening tool(24 months)
- Clinical impact of the early care pathway on blood pressure at 24 months(24 months)
- Impact on laboratory test results on cholesterol at 12 months(12 months)
- Impact on laboratory test results on C-Reactive Protein (CRP) at 24 months(24 months)
- Impact on laboratory test results on alpha2-macroglobulin at 12 months(12 months)
- Clinical impact of the early care pathway (early care) on quality of life at 12 months(12 months)
- Clinical impact of the early care pathway (early care) on quality of life at 24 months(24 months)
- Clinical impact of the early care pathway on pharmacological treatments at 24 months(24 months)
- Impact on laboratory test results on hepatic transaminases at 24 months(24 months)
- Impact on laboratory test results on creatinine at 24 months(24 months)
- Impact on laboratory test results on C-Reactive Protein (CRP) at 12 months(12 months)
- Impact on laboratory test results on triglycerides at 24 months(24 months)
- Impact on laboratory test results on glycaemia at 12 months(12 months)
- Impact on laboratory test results on Homeostasis model assessment (HOMA)-index at 12 months(12 months)
- Impact on laboratory test results on creatinine at 12 months(12 months)