Inflammation and Oxidative Stress of Adipose Tissue in Sleep Apnea Syndrome
NCT ID: NCT01196845
Last Updated: 2025-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
40 participants
INTERVENTIONAL
2010-10-16
2017-02-16
Brief Summary
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An interim analysis will be performed when 40 patients will be included.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
SINGLE
Study Groups
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obese + cPAP
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.
cPAP
Patients are randomised in 2 arms : cPAP or sham cPAP
obese + Sham cPAP
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.
cPAP
Patients are randomised in 2 arms : cPAP or Sham cPAP
non-obese + cPAP
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.
cPAP
Patients are randomised in 2 arms : cPAP or sham cPAP
non-obese + Sham cPAP
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.
cPAP
Patients are randomised in 2 arms : cPAP or sham cPAP
Interventions
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cPAP
Patients are randomised in 2 arms : cPAP or sham cPAP
cPAP
Patients are randomised in 2 arms : cPAP or Sham cPAP
cPAP
Patients are randomised in 2 arms : cPAP or sham cPAP
cPAP
Patients are randomised in 2 arms : cPAP or sham cPAP
Eligibility Criteria
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Inclusion Criteria
* Apnea Hypopnea Index \> 30/h and \> 5% TST with SaO2 \< 90%
* patients obese (BMI \> 33kg/m2) or non obese (BMI \< 27kg/m2)
Exclusion Criteria
* coronary ischemic disease, past history of CVA
* chronic pulmonary disease measured by arterial gasometry (PaO2 \< 60mmHg and/or PaCO2 \> 45mmHg)
* known hepatic disease
* alcohol consumption \> 3 units/day
* sleepiness considered to be dangerous by the investigator
* patient having an hazardous work regarding to awareness
* patient being under anticoagulant, antiplatelet drug or having an active stent or bleeding disorder
* patient having an inflammatory syndrome (C-reactive Protein \> 10)
* any allergy to local anaesthetics
* chronic muscle pain
* contraindication to MRI
18 Years
69 Years
MALE
No
Sponsors
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Centre Hospitalier Universitaire de Saint Etienne
OTHER
Hospices Civils de Lyon
OTHER
University Hospital, Geneva
OTHER
University Hospital, Grenoble
OTHER
Responsible Party
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Principal Investigators
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Jean Louis PEPIN, ProfessorPhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Grenoble
Locations
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University Hospital Grenoble
Grenoble, , France
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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2009-A00826-51
Identifier Type: REGISTRY
Identifier Source: secondary_id
09-CHUG-25
Identifier Type: -
Identifier Source: org_study_id