Clinical trial NCT01089257: Cardiovascular Impairments and Obstructive Sleep Apnea Syndrome
Official title: Subclinical Cardiovascular Impairments in Patients With Obstructive Sleep Apnea Syndrome
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Subclinical Cardiovascular Impairments
Obstructive Sleep Apnea Syndrome
Keywords: Cardiovascular risks
Oxidative stress
Systemic inflammation
Endothelial function
Peripheral Arterial Tone
Positive Airway Pressure
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier Universitaire de Saint Etienne
name: University Hospital, Clermont-Ferrand
name: Hôpital de la Croix-Rousse
First posted: 2010-03-18
Enrollment: 133
Sex: ALL
Minimum age (years): 18
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with obstructive sleep apnea syndrome (Apnea/Hypopnea index \> 15)

Brief summary: Which are the anthropometric parameters and/or of severity of the syndrome of apnea of sleep (SAS) which make it possible to anticipate occurred of vascular anomalies, anatomical and/or functional precociously found among patients SAS? Secondary objectives:

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)?


Eligibility criteria: Inclusion Criteria:

* Male or female from 18 to 78 years old
* 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:

* Body Mass Index upper or equal to 30
* 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: France : Laboratoire d'explorations fonctionnelles du système nerveux - Functional explorations laboratory of nervous system
city: Grenoble
country: France
facility: France : Laboratoire EFCR - Functional cardiorespiratory explorations laboratory
city: St Etienne
country: France
facility: France : Laboratoire EFCR - Functional cardiorespiratory explorations laboratory
Study officials:
affiliation: University Hospital, Grenoble
name: Jean-Louis JP PEPIN, ProfessorPhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.