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

Medico-economic and Quality of Life Evaluations in Obese Patients Followed by Medical Analysis Laboratories

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.

Study Overview

• Status: Withdrawn
• Conditions: Obstructive Sleep Apnea; Obesity Hypoventilation Syndrome
• Intervention / Treatment: Other: Care pathway

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Vizille, France
    • ORIADE

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual care; Patients in the usual care group will be referred to their general practitioner (GP) / primary care practitioner as usual.
Active Comparator: 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	Other: Care pathway; Screening for OSA using a combination of bicarbonate assay and STOP-BANG questionnaire and further management by a pneumologist as necessary

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
2-year medico-economic impact of the implementation of early care in obese patients with OSA	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	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Economic impact of the implementation of early care in obese patients with OSA over 3 years on the healthcare costs	The economic impact on healthcare costs from the Health Insurer's perspective will be calculated from the difference in healthcare costs between the two groups (early care vs usual care)	3 years
To evaluate the sensitivity of the screening tool	The sensitivity will be evaluated by comparison with polysomnography	24 months
To evaluate the specificity of the screening tool	The specificity will be evaluated by comparison with polysomnography	24 months
To evaluate the negative Predictive Value	The negative predictive value will be evaluated by comparison with polysomnography	24 months
To evaluate the positive predictive value of the screening tool	The positive predictive value will be evaluated by comparison with polysomnography	24 months
Clinical impact of the early care pathway on blood pressure at 12 months	Blood pressure at home	12 months
Clinical impact of the early care pathway on blood pressure at 24 months	Blood pressure at home	24 months
Clinical impact of the early care pathway on quality of life at 12 months	The EQ-5D-5L health status questionnaire, This scale is numbered from 0 to 100. 100 means the best health status. 0 means the worst health status.	12 months
Clinical impact of the early care pathway on quality of life at 24 months	The EQ-5D-5L health status questionnaire, This scale is numbered from 0 to 100. 100 means the best health status. 0 means the worst health status.	24 months
Clinical impact of the early care pathway (early care) on quality of life at 12 months	Stroke and Aphasia Quality of Life Scale (SAQOL), This questionnaire is intended to study the relationship between sleep and the quality of life. This scale is numbered from 0 to 4. higher values represent a worse outcome	12 months
Clinical impact of the early care pathway (early care) on quality of life at 24 months	Stroke and Aphasia Quality of Life Scale (SAQOL), This questionnaire is intended to study the relationship between sleep and the quality of life. This scale is numbered from 0 to 4. higher values represent a worse outcome	24 months
Clinical impact of the early care pathway on pharmacological treatments at 12 months	number of pharmacological treatments	12 months
Clinical impact of the early care pathway on pharmacological treatments at 24 months	number of pharmacological treatments	24 months
Impact on laboratory test results (troponin) at 12 months	troponin	12 months
Impact on laboratory test results (troponin) at 24 months	troponin	24 months
Impact on laboratory test results (NT-proBNP) at 12 months	NT-proBNP	12 months
Impact on laboratory test results (NT-proBNP) at 24 months	NT-proBNP	24 months
Impact on laboratory test results on cholesterol at 12 months	cholesterol	12 months
Impact on laboratory test results on cholesterol at 24 months	cholesterol	24 months
Impact on laboratory test results on triglycerides at 12 months	triglycerides	12 months
Impact on laboratory test results on triglycerides at 24 months	triglycerides	24 months
Impact on laboratory test results on glycaemia at 12 months	glycaemia	12 months
Impact on laboratory test results on glycaemia at 24 months	glycaemia	24 months
Impact on laboratory test results on Homeostasis model assessment (HOMA)-index at 12 months	Homeostasis model assessment (HOMA)-index	12 months
Impact on laboratory test results on Homeostasis model assessment (HOMA)-index at 24 months	Homeostasis model assessment (HOMA)-index	24 months
Impact on laboratory test results on hepatic transaminases at 12 months	transaminases (ASAT, ALAT)	12 months
Impact on laboratory test results on hepatic transaminases at 24 months	transaminases (ASAT, ALAT)	24 months
Impact on laboratory test results on creatinine at 12 months	creatinine	12 months
Impact on laboratory test results on creatinine at 24 months	creatinine	24 months
Impact on laboratory test results on C-Reactive Protein (CRP) at 12 months	C-Reactive Protein (CRP)	12 months
Impact on laboratory test results on C-Reactive Protein (CRP) at 24 months	C-Reactive Protein (CRP)	24 months
Impact on laboratory test results on alpha2-macroglobulin at 12 months	alpha2-macroglobulin	12 months
Impact on laboratory test results on alpha2-macroglobulin at 24 months	alpha2-macroglobulin	24 months

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble
• Collaborators: University Hospital, Angers; Poitiers University Hospital; Union hospital, Toulouse; Hospital Alpes Leman, Annemasse; Hospital La Louvière, Lille; Oriade Laboratory, Vizille; Cerballiance laboratories, Lille; Oriade laboratory, Annemasse
• Investigators: Principal Investigator: Jean-Louis PEPIN, MD, PhD, Grenoble Alpes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2019
• Primary Completion (Actual): December 6, 2022
• Study Completion (Actual): December 6, 2022

Study Registration Dates

• First Submitted: February 22, 2019
• First Submitted That Met QC Criteria: March 1, 2019
• First Posted (Actual): March 4, 2019

Study Record Updates

• Last Update Posted (Actual): January 5, 2023
• Last Update Submitted That Met QC Criteria: January 3, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: obstructive sleep apnea; obesity hypoventilation syndrome; bicarbonates; STOP-BANG
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Overnutrition; Nutrition Disorders; Signs and Symptoms, Respiratory; Respiratory Insufficiency; Obesity; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Hypoventilation; Obesity Hypoventilation Syndrome
• Other Study ID Numbers: 38RC17.360

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No