Cardiovascular Impairments and Obstructive Sleep Apnea Syndrome
NCT ID: NCT01089257
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
133 participants
OBSERVATIONAL
2007-11-30
2021-06-30
Brief Summary
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1. Which are the anthropometric parameters and/or of severity of SAS allowing to anticipate occurred of early of the cardiac function and/or rhythmic anomalies found among patients SAS?
2. Do there exist biological markers who allow to anticipate the early vascular lesions or the anomalies beginners of the cardiac function?
3. Which are the cardiovascular effects of a treatment of SAS by Continuous Positive Pressure (PC) after 3 to 6 months of treatment?
4. Do the identified early cardiovascular attacks and/or the biological anomalies make it possible to predict occurred of cardiovascular events in this population of patients carrying SAS (followed longitudinal at 5 years)?
Detailed Description
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Conditions
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Keywords
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Study Design
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CASE_CONTROL
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Patients with obstructive sleep apnea syndrome (Apnea/Hypopnea index \> 15)
* ambulatory patients
* patients who have signed the inform consent form
* patients with health insurance
Exclusion Criteria
* cardiovascular pathology except blood pressure hypertension
* known or treated diabetes
* pathologies with consequence on blood pressure regulation
* drugs intakes with consequence on blood pressure regulation
* patient with chronic obstructive pulmonary disease
* atrial fibrillation or more than 10/minute extrasystoles
* bedridden patients or patients with decreased mobility
* patients working at night or with shift work
* patients with carotid stenting or surgery history
* patients unable to sign the inform consent form
* patients already treated by cPAP or dental appliance for OSAS in the last 6 months
* pregnant or suckling female
* patients under supervision or trusteeship
* patients taking part in another clinical trial
18 Years
78 Years
ALL
Yes
Sponsors
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Centre Hospitalier Universitaire de Saint Etienne
OTHER
University Hospital, Clermont-Ferrand
OTHER
Hôpital de la Croix-Rousse
OTHER
University Hospital, Grenoble
OTHER
Responsible Party
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Principal Investigators
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Jean-Louis JP PEPIN, ProfessorPhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Grenoble
Locations
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France : Laboratoire d'explorations fonctionnelles du système nerveux - Functional explorations laboratory of nervous system
Clermont-Ferrand, , France
France : Laboratoire EFCR - Functional cardiorespiratory explorations laboratory
Grenoble, , France
France : Laboratoire EFCR - Functional cardiorespiratory explorations laboratory
Saint-Etienne, , France
Countries
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References
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Parish JM, Somers VK. Obstructive sleep apnea and cardiovascular disease. Mayo Clin Proc. 2004 Aug;79(8):1036-46. doi: 10.4065/79.8.1036.
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.
Lattimore JD, Celermajer DS, Wilcox I. Obstructive sleep apnea and cardiovascular disease. J Am Coll Cardiol. 2003 May 7;41(9):1429-37. doi: 10.1016/s0735-1097(03)00184-0.
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.
Drager LF, Bortolotto LA, Lorenzi MC, Figueiredo AC, Krieger EM, Lorenzi-Filho G. Early signs of atherosclerosis in obstructive sleep apnea. Am J Respir Crit Care Med. 2005 Sep 1;172(5):613-8. doi: 10.1164/rccm.200503-340OC. Epub 2005 May 18.
Baguet JP, Boutin I, Barone-Rochette G, Levy P, Tamisier R, Pierre H, Boggetto-Graham L, Pepin JL. Hypertension diagnosis in obstructive sleep apnea: self or 24-hour ambulatory blood pressure monitoring? Int J Cardiol. 2013 Sep 1;167(5):2346-7. doi: 10.1016/j.ijcard.2012.11.037. Epub 2012 Nov 22. No abstract available.
Stanke-Labesque F, Pepin JL, de Jouvencel T, Arnaud C, Baguet JP, Petri MH, Tamisier R, Jourdil JF, Levy P, Back M. Leukotriene B4 pathway activation and atherosclerosis in obstructive sleep apnea. J Lipid Res. 2012 Sep;53(9):1944-51. doi: 10.1194/jlr.P022814. Epub 2012 Jul 3.
Other Identifiers
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06PHR03
Identifier Type: -
Identifier Source: org_study_id