An interventional study of Care pathway in Obesity Hypoventilation Syndrome and Obstructive Sleep Apnea, sponsored by University Hospital, Grenoble. Withdrawn at 1 site in France. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-01-05.
Sponsored by University Hospital, Grenoble · Not applicable, Interventional, and Screening
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.
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.
2,162 studies on the registry are indexed under Sleep Apnea Syndromes; 290 are open to participants now.
Browse Sleep Apnea Syndromes studies →University Hospital, Grenoble is the lead sponsor of 815 studies on the registry; 205 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients in the usual care group will be referred to their general practitioner (GP) / primary care practitioner as usual.
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
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
Time frame: 24 months
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)
Time frame: 3 years
To evaluate the sensitivity of the screening tool
The sensitivity will be evaluated by comparison with polysomnography
Time frame: 24 months
To evaluate the specificity of the screening tool
The specificity will be evaluated by comparison with polysomnography
Time frame: 24 months
To evaluate the negative Predictive Value
The negative predictive value will be evaluated by comparison with polysomnography
Time frame: 24 months
To evaluate the positive predictive value of the screening tool
The positive predictive value will be evaluated by comparison with polysomnography
Time frame: 24 months
Clinical impact of the early care pathway on blood pressure at 12 months
Blood pressure at home
Time frame: 12 months
Clinical impact of the early care pathway on blood pressure at 24 months
Blood pressure at home
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 24 months
Clinical impact of the early care pathway on pharmacological treatments at 12 months
number of pharmacological treatments
Time frame: 12 months
Clinical impact of the early care pathway on pharmacological treatments at 24 months
number of pharmacological treatments
Time frame: 24 months
Impact on laboratory test results (troponin) at 12 months
troponin
Time frame: 12 months
Impact on laboratory test results (troponin) at 24 months
troponin
Time frame: 24 months
Impact on laboratory test results (NT-proBNP) at 12 months
NT-proBNP
Time frame: 12 months
Impact on laboratory test results (NT-proBNP) at 24 months
NT-proBNP
Time frame: 24 months
Impact on laboratory test results on cholesterol at 12 months
cholesterol
Time frame: 12 months
Impact on laboratory test results on cholesterol at 24 months
cholesterol
Time frame: 24 months
Impact on laboratory test results on triglycerides at 12 months
triglycerides
Time frame: 12 months
Impact on laboratory test results on triglycerides at 24 months
triglycerides
Time frame: 24 months
Impact on laboratory test results on glycaemia at 12 months
glycaemia
Time frame: 12 months
Impact on laboratory test results on glycaemia at 24 months
glycaemia
Time frame: 24 months
Impact on laboratory test results on Homeostasis model assessment (HOMA)-index at 12 months
Homeostasis model assessment (HOMA)-index
Time frame: 12 months
Impact on laboratory test results on Homeostasis model assessment (HOMA)-index at 24 months
Homeostasis model assessment (HOMA)-index
Time frame: 24 months
Impact on laboratory test results on hepatic transaminases at 12 months
transaminases (ASAT, ALAT)
Time frame: 12 months
Impact on laboratory test results on hepatic transaminases at 24 months
transaminases (ASAT, ALAT)
Time frame: 24 months
Impact on laboratory test results on creatinine at 12 months
creatinine
Time frame: 12 months
Impact on laboratory test results on creatinine at 24 months
creatinine
Time frame: 24 months
Impact on laboratory test results on C-Reactive Protein (CRP) at 12 months
C-Reactive Protein (CRP)
Time frame: 12 months
Impact on laboratory test results on C-Reactive Protein (CRP) at 24 months
C-Reactive Protein (CRP)
Time frame: 24 months
Impact on laboratory test results on alpha2-macroglobulin at 12 months
alpha2-macroglobulin
Time frame: 12 months
Impact on laboratory test results on alpha2-macroglobulin at 24 months
alpha2-macroglobulin
Time frame: 24 months
Plan to share: Undecided
No publications or documents are linked to this record.
This study is withdrawn, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University Hospital, Grenoble