Cardiovascular Impairments and Obstructive Sleep Apnea Syndrome

Obstructive Sleep Apnea Syndrome Clinical Trial

— INFRASAS  

Official title:

Subclinical Cardiovascular Impairments in Patients With Obstructive Sleep Apnea Syndrome

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01089257
• Other study ID #: 06PHR03
• Status: Terminated
• Start date: November 2007
• Est. completion date: June 2021

Study information

• Verified date: January 2023
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)?

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 133
• Est. completion date: June 2021
• Est. primary completion date: November 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 78 Years

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea Syndrome
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Subclinical Cardiovascular Impairments
• Syndrome

Locations

Country	Name	City	State
France	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	St Etienne

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital, Grenoble	Centre Hospitalier Universitaire de Saint Etienne, Hôpital de la Croix-Rousse, University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation