Cardiovascular Impairments and Obstructive Sleep Apnea Syndrome

NCT01089257 | Terminated

• 1 other identifier: 06PHR03
• Study Type: observational
• Target: 133
• Locations: 1 country
• Sites: 3

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. 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. 2.Do there exist biological markers who allow to anticipate the early vascular lesions or the anomalies beginners of the cardiac function?
3. 3.Which are the cardiovascular effects of a treatment of SAS by Continuous Positive Pressure (PC) after 3 to 6 months of treatment?
4. 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)?

Conditions

Subclinical Cardiovascular Impairments; Obstructive Sleep Apnea Syndrome

Keywords

Cardiovascular risks; Oxidative stress; Systemic inflammation; Endothelial function; Peripheral Arterial Tone; Positive Airway Pressure

Eligibility Criteria

• Age: 18 Years - 78 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with obstructive sleep apnea syndrome (Apnea/Hypopnea index \> 15)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Grenoble: lead
• Centre Hospitalier Universitaire de Saint Etienne: collaborator
• University Hospital, Clermont-Ferrand: collaborator
• Hôpital de la Croix-Rousse: collaborator

Study Sites (3)

France : Laboratoire d'explorations fonctionnelles du système nerveux - Functional explorations laboratory of nervous system

Clermont-Ferrand, 63000, France

Location

France : Laboratoire EFCR - Functional cardiorespiratory explorations laboratory

Grenoble, 38000, France

Location

France : Laboratoire EFCR - Functional cardiorespiratory explorations laboratory

Saint-Etienne, 42000, France

Location

Related Publications (7)

• 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.

  PMID: 12742277 BACKGROUND

• 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.

  PMID: 15301332 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.

  PMID: 14532320 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.

  PMID: 15781100 BACKGROUND

• 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.

  PMID: 15901608 BACKGROUND

• 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.

  PMID: 23176771 RESULT

• 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.

  PMID: 22761257 DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Jean-Louis JP PEPIN, ProfessorPhD

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2010
• First Posted: March 18, 2010
• Study Start: November 1, 2007
• Primary Completion: November 1, 2012
• Study Completion: June 1, 2021
• Last Updated: December 29, 2025

Record last verified: 2025-12

Locations

FR (3)