Obstructive Sleep Apnea Clinical Trial
— BIOSAOSOfficial title:
Medico-economic and Quality of Life Evaluations in Obese Patients Followed by Medical Analysis Laboratories
Verified date | January 2023 |
Source | University Hospital, Grenoble |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | December 6, 2022 |
Est. primary completion date | December 6, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
France | ORIADE | Vizille |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Grenoble | Cerballiance laboratories, Lille, Hospital Alpes Leman, Annemasse, Hospital La Louvière, Lille, Oriade laboratory, Annemasse, Oriade Laboratory, Vizille, Poitiers University Hospital, Union hospital, Toulouse, University Hospital, Angers |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | To evaluate the sensitivity of the screening tool | The sensitivity will be evaluated by comparison with polysomnography | 24 months | |
Secondary | To evaluate the specificity of the screening tool | The specificity will be evaluated by comparison with polysomnography | 24 months | |
Secondary | To evaluate the negative Predictive Value | The negative predictive value will be evaluated by comparison with polysomnography | 24 months | |
Secondary | To evaluate the positive predictive value of the screening tool | The positive predictive value will be evaluated by comparison with polysomnography | 24 months | |
Secondary | Clinical impact of the early care pathway on blood pressure at 12 months | Blood pressure at home | 12 months | |
Secondary | Clinical impact of the early care pathway on blood pressure at 24 months | Blood pressure at home | 24 months | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Clinical impact of the early care pathway on pharmacological treatments at 12 months | number of pharmacological treatments | 12 months | |
Secondary | Clinical impact of the early care pathway on pharmacological treatments at 24 months | number of pharmacological treatments | 24 months | |
Secondary | Impact on laboratory test results (troponin) at 12 months | troponin | 12 months | |
Secondary | Impact on laboratory test results (troponin) at 24 months | troponin | 24 months | |
Secondary | Impact on laboratory test results (NT-proBNP) at 12 months | NT-proBNP | 12 months | |
Secondary | Impact on laboratory test results (NT-proBNP) at 24 months | NT-proBNP | 24 months | |
Secondary | Impact on laboratory test results on cholesterol at 12 months | cholesterol | 12 months | |
Secondary | Impact on laboratory test results on cholesterol at 24 months | cholesterol | 24 months | |
Secondary | Impact on laboratory test results on triglycerides at 12 months | triglycerides | 12 months | |
Secondary | Impact on laboratory test results on triglycerides at 24 months | triglycerides | 24 months | |
Secondary | Impact on laboratory test results on glycaemia at 12 months | glycaemia | 12 months | |
Secondary | Impact on laboratory test results on glycaemia at 24 months | glycaemia | 24 months | |
Secondary | Impact on laboratory test results on Homeostasis model assessment (HOMA)-index at 12 months | Homeostasis model assessment (HOMA)-index | 12 months | |
Secondary | Impact on laboratory test results on Homeostasis model assessment (HOMA)-index at 24 months | Homeostasis model assessment (HOMA)-index | 24 months | |
Secondary | Impact on laboratory test results on hepatic transaminases at 12 months | transaminases (ASAT, ALAT) | 12 months | |
Secondary | Impact on laboratory test results on hepatic transaminases at 24 months | transaminases (ASAT, ALAT) | 24 months | |
Secondary | Impact on laboratory test results on creatinine at 12 months | creatinine | 12 months | |
Secondary | Impact on laboratory test results on creatinine at 24 months | creatinine | 24 months | |
Secondary | Impact on laboratory test results on C-Reactive Protein (CRP) at 12 months | C-Reactive Protein (CRP) | 12 months | |
Secondary | Impact on laboratory test results on C-Reactive Protein (CRP) at 24 months | C-Reactive Protein (CRP) | 24 months | |
Secondary | Impact on laboratory test results on alpha2-macroglobulin at 12 months | alpha2-macroglobulin | 12 months | |
Secondary | Impact on laboratory test results on alpha2-macroglobulin at 24 months | alpha2-macroglobulin | 24 months |
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