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
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