Cardiovascular Impairments and Obstructive Sleep Apnea Syndrome (INFRASAS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by University Hospital, Grenoble.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Centre Hospitalier Universitaire de Saint Etienne
University Hospital, Clermont-Ferrand
La Croix Rousse Hospital, Lyon
Information provided by:
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT01089257
First received: March 16, 2010
Last updated: October 18, 2013
Last verified: March 2010
  Purpose

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)?

Condition
Subclinical Cardiovascular Impairments
Obstructive Sleep Apnea Syndrome

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Subclinical Cardiovascular Impairments in Patients With Obstructive Sleep Apnea Syndrome

Resource links provided by NLM:


Further study details as provided by University Hospital, Grenoble:

Estimated Enrollment: 580
Study Start Date: September 2007
Estimated Study Completion Date: January 2014
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 78 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01089257

Contacts
Contact: Jean Louis JP PEPIN, PhD 0033476765516 JPepin@chu-grenoble.fr

Locations
France
France : Laboratoire d'explorations fonctionnelles du système nerveux - Functional explorations laboratory of nervous system Recruiting
Clermont-Ferrand, France, 63000
Contact: Patricia PB BEUDIN, Doctor    0033473751666      
Sub-Investigator: Jean JP PONSONNAILLE, ProfessorPhD         
Sub-Investigator: Aimé AA AMONCHOT, Doctor         
Sub-Investigator: Annick AG GREIL, Doctor         
France : Laboratoire EFCR - Functional cardiorespiratory explorations laboratory Recruiting
Grenoble, France, 38000
Contact: Jean-Louis JP PEPIN, ProfessorPhD    0033476765516    JPepin@chu-grenoble.fr   
Sub-Investigator: Patrick PL LEVY, ProfessorPhD         
Sub-Investigator: Renaud RT TAMISIER, Doctor         
Sub-Investigator: Jean-Philippe JB BAGUET, ProfessorPhD         
Sub-Investigator: Patrice PF FAURE, Doctor         
Sub-Investigator: Pascal PD DEFAYE, Doctor         
France : Laboratoire EFCR - Functional cardiorespiratory explorations laboratory Recruiting
St Etienne, France, 42000
Contact: Frédéric FR ROCHE, Doctor    0033477828300      
Sub-Investigator: Isabelle IC COURT-FORTUNE, Doctor         
Sub-Investigator: Séverine SF FEASSON, Doctor         
Sponsors and Collaborators
University Hospital, Grenoble
Centre Hospitalier Universitaire de Saint Etienne
University Hospital, Clermont-Ferrand
La Croix Rousse Hospital, Lyon
Investigators
Principal Investigator: Jean-Louis JP PEPIN, ProfessorPhD University Hospital, Grenoble
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pépin Jean-Louis, Professor, Laboratoire du sommeil et Laboratoire d'EFCR
ClinicalTrials.gov Identifier: NCT01089257     History of Changes
Other Study ID Numbers: 06PHR03
Study First Received: March 16, 2010
Last Updated: October 18, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Grenoble:
Cardiovascular risks
Oxidative stress
Systemic inflammation
Endothelial function
Peripheral Arterial Tone
Positive Airway Pressure

Additional relevant MeSH terms:
Sleep Apnea, Obstructive
Sleep Apnea Syndromes
Apnea
Syndrome
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Disease
Pathologic Processes

ClinicalTrials.gov processed this record on September 22, 2014