Cardiovascular Impairments and Obstructive Sleep Apnea Syndrome (INFRASAS)

January 3, 2023 updated by: University Hospital, Grenoble

Subclinical Cardiovascular Impairments in Patients With Obstructive Sleep Apnea Syndrome

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)?

Study Overview

Status

Terminated

Conditions

Study Type

Observational

Enrollment (Actual)

133

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont-Ferrand, France, 63000
        • France : Laboratoire d'explorations fonctionnelles du système nerveux - Functional explorations laboratory of nervous system
      • Grenoble, France, 38000
        • France : Laboratoire EFCR - Functional cardiorespiratory explorations laboratory
      • St Etienne, France, 42000
        • France : Laboratoire EFCR - Functional cardiorespiratory explorations laboratory

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2007

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

June 1, 2021

Study Registration Dates

First Submitted

March 16, 2010

First Submitted That Met QC Criteria

March 16, 2010

First Posted (Estimate)

March 18, 2010

Study Record Updates

Last Update Posted (Actual)

January 5, 2023

Last Update Submitted That Met QC Criteria

January 3, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06PHR03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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