Back to resultsPredictive Factors of Obesity-hypoventilation Syndrome (OHS) Among Obese Subjects- ETUDE COHYPOB -
Primary Purpose
Obesity-hypoventilation Syndrome, Nocturnal Alveolar Hypoventilation
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Annual visits among 3 years. During each visit different testings are performed in order to detect an obesity-hypoventilation syndrome (OHS)
Sponsored by
About this trial
This is an interventional prevention trial for Obesity-hypoventilation Syndrome focused on measuring OHS
Eligibility 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
Sites / Locations
- CHU Angers
- CHU Brest
- CH Cannes
- CHU Grenoble
- CHU Reims
- CHU Strasbourg
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Obesity: BMI > 30 kg/m2
Arm Description
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
Outcomes
Primary Outcome Measures
Occurrence of obesity-hypoventilation syndrome
partial pressure of carbon dioxide in the arterial blood > 45mmHg
Secondary Outcome Measures
Full Information
NCT ID
NCT02021448
First Posted
August 29, 2013
Last Updated
July 7, 2022
Sponsor
University Hospital, Strasbourg, France
1. Study Identification
Unique Protocol Identification Number
NCT02021448
Brief Title
Predictive Factors of Obesity-hypoventilation Syndrome (OHS) Among Obese Subjects- ETUDE COHYPOB -
Official Title
Predictive Factors of Obesity-hypoventilation Syndrome (OHS) Among Obese Subjects- ETUDE COHYPOB -
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Terminated
Why Stopped
difficulty in recruiting
Study Start Date
December 2013 (Actual)
Primary Completion Date
January 2022 (Actual)
Study Completion Date
June 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Strasbourg, France
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity-hypoventilation Syndrome, Nocturnal Alveolar Hypoventilation
Keywords
OHS
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
188 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Obesity: BMI > 30 kg/m2
Arm Type
Other
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Annual visits among 3 years. During each visit different testings are performed in order to detect an obesity-hypoventilation syndrome (OHS)
Intervention Description
Polygraphy/Polysomnography,Blood sampling, EKG,Lung function testing,Arterial blood gases,Thoracic radiography,Six-minute walk test,Respiratory questionnaires
Primary Outcome Measure Information:
Title
Occurrence of obesity-hypoventilation syndrome
Description
partial pressure of carbon dioxide in the arterial blood > 45mmHg
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
KESSLER Romain, MD
Organizational Affiliation
University Hospital, Strasbourg, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Angers
City
Angers
ZIP/Postal Code
49000
Country
France
Facility Name
CHU Brest
City
Brest
ZIP/Postal Code
29609
Country
France
Facility Name
CH Cannes
City
Cannes
ZIP/Postal Code
06400
Country
France
Facility Name
CHU Grenoble
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
CHU Reims
City
Reims
ZIP/Postal Code
51100
Country
France
Facility Name
CHU Strasbourg
City
Strasbourg
ZIP/Postal Code
67091
Country
France
12. IPD Sharing Statement
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Predictive Factors of Obesity-hypoventilation Syndrome (OHS) Among Obese Subjects- ETUDE COHYPOB -
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