Predictive Factors of Obesity-hypoventilation Syndrome (OHS) Among Obese Subjects- ETUDE COHYPOB –

Overview

Investigate whether the course of an isolated nocturnal alveolar hypoventilation can predict the future occurrence of obesity-hypoventilation syndrome (OHS) in obese subjects

Full Title of Study: “Predictive Factors of Obesity-hypoventilation Syndrome (OHS) Among Obese Subjects- ETUDE COHYPOB -“

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2022

Interventions

  • Other: Annual visits among 3 years. During each visit different testings are performed in order to detect an obesity-hypoventilation syndrome (OHS)
    • Polygraphy/Polysomnography,Blood sampling, EKG,Lung function testing,Arterial blood gases,Thoracic radiography,Six-minute walk test,Respiratory questionnaires

Arms, Groups and Cohorts

  • Other: Obesity: BMI > 30 kg/m2
    • Annual visits among 3 years. During each visit different testings are performed in order to detect an obesity-hypoventilation syndrome (OHS) Polygraphy/Polysomnography, Blood sampling, EKG, Lung function testing, Arterial blood gases, Thoracic radiography, Six-minute walk test, Respiratory questionnaires

Clinical Trial Outcome Measures

Primary Measures

  • Occurrence of obesity-hypoventilation syndrome
    • Time Frame: 3 years
    • partial pressure of carbon dioxide in the arterial blood > 45mmHg

Participating in This Clinical Trial

Inclusion Criteria

  • Obese volunteer Subject (BMI> 30 kg/m2) – Adults of either sex – Social security affiliation – Written informed consent Exclusion criteria:

  • Confirmed OHS at baseline defined by a daytime hypercapnia with PaCO2> 45mmHg – Any cause of chronic respiratory failure other than obesity such as COPD, chest deformation, phrenic nerve paralysis, pulmonary fibrosis, neuromuscular disease, a history of mutilating thoracic surgery … – Obstructive ventilatory defect with FEV1/ FVC <70% post-bronchodilator – Long term oxygen therapy, noninvasive ventilation, continuous positive airway pressure – Any serious illness involving life-threatening within 3 years after inclusion – Drug or alcohol abuse – Pregnancy

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital, Strasbourg, France
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • KESSLER Romain, MD, Principal Investigator, University Hospital, Strasbourg, France

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.