Cardiovascular Impairments and Obstructive Sleep Apnea Syndrome

Terminated

• Conditions: Obstructive Sleep Apnea Syndrome; Subclinical Cardiovascular Impairments

• Registration Number: NCT01089257
• Lead Sponsor: University Hospital, Grenoble

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)?

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2010-03-16
• Study First Submitted QC: 2010-03-16
• Study First Posted: 2010-03-18
• Primary Completion: 2012-11
• Study Completion: 2021-06
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-03
• Last Update Posted: 2023-01-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 133

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (2)

France : Laboratoire EFCR - Functional cardiorespiratory explorations laboratory; 🇫🇷 St Etienne, France

France : Laboratoire d'explorations fonctionnelles du système nerveux - Functional explorations laboratory of nervous system; 🇫🇷 Clermont-Ferrand, France