INFRASAS: Cardiovascular Impairments and Obstructive Sleep Apnea Syndrome
Study Details
Study Description
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:
-
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?
-
Do there exist biological markers who allow to anticipate the early vascular lesions or the anomalies beginners of the cardiac function?
-
Which are the cardiovascular effects of a treatment of SAS by Continuous Positive Pressure (PC) after 3 to 6 months of treatment?
-
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)?
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Study Design
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | France : Laboratoire d'explorations fonctionnelles du système nerveux - Functional explorations laboratory of nervous system | Clermont-Ferrand | France | 63000 | |
2 | France : Laboratoire EFCR - Functional cardiorespiratory explorations laboratory | Grenoble | France | 38000 | |
3 | France : Laboratoire EFCR - Functional cardiorespiratory explorations laboratory | St Etienne | France | 42000 |
Sponsors and Collaborators
- University Hospital, Grenoble
- Centre Hospitalier Universitaire de Saint Etienne
- University Hospital, Clermont-Ferrand
- Hôpital de la Croix-Rousse
Investigators
- Principal Investigator: Jean-Louis JP PEPIN, ProfessorPhD, University Hospital, Grenoble
Study Documents (Full-Text)
None provided.More Information
Publications
- 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. Epub 2005 May 18.
- Lattimore JD, Celermajer DS, Wilcox I. Obstructive sleep apnea and cardiovascular disease. J Am Coll Cardiol. 2003 May 7;41(9):1429-37. Review.
- 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.
- Parish JM, Somers VK. Obstructive sleep apnea and cardiovascular disease. Mayo Clin Proc. 2004 Aug;79(8):1036-46. Review.
- Shamsuzzaman AS, Gersh BJ, Somers VK. Obstructive sleep apnea: implications for cardiac and vascular disease. JAMA. 2003 Oct 8;290(14):1906-14. Review.
- 06PHR03