INFRASAS: Cardiovascular Impairments and Obstructive Sleep Apnea Syndrome

Sponsor
University Hospital, Grenoble (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT01089257
Collaborator
Centre Hospitalier Universitaire de Saint Etienne (Other), University Hospital, Clermont-Ferrand (Other), Hôpital de la Croix-Rousse (Other)
580
3
182
193.3
1.1

Study Details

Study Description

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)?

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    580 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Subclinical Cardiovascular Impairments in Patients With Obstructive Sleep Apnea Syndrome
    Actual Study Start Date :
    Nov 1, 2007
    Actual Primary Completion Date :
    Nov 1, 2012
    Anticipated Study Completion Date :
    Jan 1, 2023

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years to 78 Years
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      Yes
      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

      Locations

      Site City State Country Postal Code
      1 France : Laboratoire d'explorations fonctionnelles du système nerveux - Functional explorations laboratory of nervous system Clermont-Ferrand France 63000
      2 France : Laboratoire EFCR - Functional cardiorespiratory explorations laboratory Grenoble France 38000
      3 France : Laboratoire EFCR - Functional cardiorespiratory explorations laboratory St Etienne France 42000

      Sponsors and Collaborators

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

      Investigators

      • Principal Investigator: Jean-Louis JP PEPIN, ProfessorPhD, University Hospital, Grenoble

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      Responsible Party:
      University Hospital, Grenoble
      ClinicalTrials.gov Identifier:
      NCT01089257
      Other Study ID Numbers:
      • 06PHR03
      First Posted:
      Mar 18, 2010
      Last Update Posted:
      Jan 18, 2020
      Last Verified:
      Jan 1, 2020

      Study Results

      No Results Posted as of Jan 18, 2020