Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02021448
Recruitment Status : Active, not recruiting
First Posted : December 27, 2013
Last Update Posted : July 27, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

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

Condition or disease Intervention/treatment Phase
Obesity-hypoventilation Syndrome Nocturnal Alveolar Hypoventilation Other: Annual visits among 3 years. During each visit different testings are performed in order to detect an obesity-hypoventilation syndrome (OHS) Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Predictive Factors of Obesity-hypoventilation Syndrome (OHS) Among Obese Subjects- ETUDE COHYPOB -
Actual Study Start Date : December 2013
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Arm Intervention/treatment
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
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




Primary Outcome Measures :
  1. Occurrence of obesity-hypoventilation syndrome [ Time Frame: 3 years ]
    partial pressure of carbon dioxide in the arterial blood > 45mmHg



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02021448


Locations
Layout table for location information
France
CHU Angers
Angers, France, 49000
CHU Brest
Brest, France, 29609
CH Cannes
Cannes, France, 06400
CHU Grenoble
Grenoble, France, 38043
CHU Reims
Reims, France, 51100
CHU Strasbourg
Strasbourg, France, 67091
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
Layout table for investigator information
Principal Investigator: KESSLER Romain, MD University Hospital, Strasbourg, France
Layout table for additonal information
Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT02021448    
Other Study ID Numbers: 5059
First Posted: December 27, 2013    Key Record Dates
Last Update Posted: July 27, 2020
Last Verified: July 2020
Keywords provided by University Hospital, Strasbourg, France:
OHS
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypoventilation
Obesity Hypoventilation Syndrome
Obesity
Syndrome
Disease
Pathologic Processes
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Apnea, Obstructive
Sleep Apnea Syndromes
Apnea
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases