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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-A00826-51 | Registry Identifier | ID RCB |
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Enrollment difficulty
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| Name | Class |
|---|---|
| Centre Hospitalier Universitaire de Saint Etienne | OTHER |
| Hospices Civils de Lyon | OTHER |
| University Hospital, Geneva | OTHER |
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The main objective of this study is to evaluate the decrease of inflammation of adipose tissue in obese and non-obese patients having a sleep apnea syndrome and treated or not by continuous positive airway pressure (cPAP).
An interim analysis will be performed when 40 patients will be included.
Inflammation of adipose tissue will be evaluated by RT-PCR on mRNA of pro and anti-inflammatory cytokines (IL-1, IL-6, IL-4, IL-10, IL-12, RANTES, TNFa, leptin, adiponectin, CD68).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| obese + cPAP | Other | Patients with sleep apnea syndrome will be first randomised in 2 arms according to their obesity. They will be secondly randomised in 2 arms receiving either cPAP treatment or Sham cPAP. |
|
| obese + Sham cPAP | Other | Patients with sleep apnea syndrome will be first randomised in 2 arms according to their obesity. They will be secondly randomised in 2 arms receiving either cPAP treatment or Sham cPAP. |
|
| non-obese + cPAP | Other | Patients with sleep apnea syndrome will be first randomised in 2 arms according to their obesity. They will be secondly randomised in 2 arms receiving either cPAP treatment or Sham cPAP. |
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| non-obese + Sham cPAP | Other | Patients with sleep apnea syndrome will be first randomised in 2 arms according to their obesity. They will be secondly randomised in 2 arms receiving either cPAP treatment or Sham cPAP. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cPAP | Device | Patients are randomised in 2 arms : cPAP or sham cPAP |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Decrease of inflammation in adipose tissue | Obese and non-obese patients having a sleep apnea syndrome will be treated by cPAP or not (placebo arm). Decrease of inflammation in adipose tissue is expected to be observed in patients treated by cPAP. | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Decrease of oxidative stress | Measures of oxidative stress will be done in obese and non-obese patients treated either by cPAP or "Placebo cPAP" | 2 months |
| measure of insulin sensitivity | Insulin sensitivity will be measured in obese and non-obese patients treated either by cPAP or "placebo cPAP" |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean Louis PEPIN, ProfessorPhD | University Hospital, Grenoble | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Grenoble | Grenoble | 38000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16304292 | Background | Baguet JP, Hammer L, Levy P, Pierre H, Launois S, Mallion JM, Pepin JL. The severity of oxygen desaturation is predictive of carotid wall thickening and plaque occurrence. Chest. 2005 Nov;128(5):3407-12. doi: 10.1378/chest.128.5.3407. | |
| 14532320 | Background | Shamsuzzaman AS, Gersh BJ, Somers VK. Obstructive sleep apnea: implications for cardiac and vascular disease. JAMA. 2003 Oct 8;290(14):1906-14. doi: 10.1001/jama.290.14.1906. |
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| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
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| cPAP |
| Device |
Patients are randomised in 2 arms : cPAP or Sham cPAP |
|
| cPAP | Device | Patients are randomised in 2 arms : cPAP or sham cPAP |
|
| cPAP | Device | Patients are randomised in 2 arms : cPAP or sham cPAP |
|
| 2 months |
| Decrease of systemic inflammation | This measure will be done in obese and non-obese patients treated either by cPAP or "placebo cPAP" | 2 months |
| Measure of local hypoxemia of adipose tissue | This measure will be done in obese and non-obese patients treated either by cPAP or "placebo cPAP" | 2 months |
| Measure of structural and functional changes in skeletal muscle | This measure will be done in obese and non-obese patients treated either by cPAP or "placebo cPAP" | 2 months |
| Measure of vascular adhesion factors modifications and protein synthesis signals modifications | This measure will be done in musculus skeletal of obese and non-obese patients treated either by cPAP or "placebo cPAP" | 2 months |
| Decrease in endothelial dysfunction | This measure will be done in obese and non-obese patients treated either by cPAP or "placebo cPAP" and correlated to decrease of inflammation and oxidative stress | 2 months |
| Decrease in arterial rigidity | This measure will be done in obese and non-obese patients treated either by cPAP or "placebo cPAP" and correlated to decrease of inflammation and oxidative stress | 2 months |
| 17395738 | Background | Hosogai N, Fukuhara A, Oshima K, Miyata Y, Tanaka S, Segawa K, Furukawa S, Tochino Y, Komuro R, Matsuda M, Shimomura I. Adipose tissue hypoxia in obesity and its impact on adipocytokine dysregulation. Diabetes. 2007 Apr;56(4):901-11. doi: 10.2337/db06-0911. |
| 15781100 | Background | Marin JM, Carrizo SJ, Vicente E, Agusti AG. Long-term cardiovascular outcomes in men with obstructive sleep apnoea-hypopnoea with or without treatment with continuous positive airway pressure: an observational study. Lancet. 2005 Mar 19-25;365(9464):1046-53. doi: 10.1016/S0140-6736(05)71141-7. |
| 17251237 | Background | Coughlin SR, Mawdsley L, Mugarza JA, Wilding JP, Calverley PM. Cardiovascular and metabolic effects of CPAP in obese males with OSA. Eur Respir J. 2007 Apr;29(4):720-7. doi: 10.1183/09031936.00043306. Epub 2007 Jan 24. |
| 12586529 | Background | Lavie L. Obstructive sleep apnoea syndrome--an oxidative stress disorder. Sleep Med Rev. 2003 Feb;7(1):35-51. doi: 10.1053/smrv.2002.0261. |
| 26567858 | Result | Jullian-Desayes I, Tamisier R, Zarski JP, Aron-Wisnewsky J, Launois-Rollinat SH, Trocme C, Levy P, Joyeux-Faure M, Pepin JL. Impact of effective versus sham continuous positive airway pressure on liver injury in obstructive sleep apnoea: Data from randomized trials. Respirology. 2016 Feb;21(2):378-85. doi: 10.1111/resp.12672. Epub 2015 Nov 16. |
| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |