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Cardiovascular Impairments and Obstructive Sleep Apnea Syndrome (INFRASAS)

This study is currently recruiting participants.
Verified March 2010 by University Hospital, Grenoble
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: NA
Last verified: March 2010
History: No changes posted
  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:

MedlinePlus related topics: Sleep Apnea
U.S. FDA Resources

Further study details as provided by University Hospital, Grenoble:

Estimated Enrollment: 580
Study Start Date: September 2007
Estimated Study Completion Date: September 2013
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
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: March 16, 2010
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 Syndromes
Sleep Apnea, Obstructive
Apnea
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
 Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on June 17, 2013