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

Obesity-hypoventilation Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02021448
• Other study ID #: 5059
• Status: Terminated
• Phase: N/A
• Start date: December 2013
• Est. completion date: June 2022

Study information

• Verified date: July 2022
• Source: University Hospital, Strasbourg, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 188
• Est. completion date: June 2022
• Est. primary completion date: January 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypoventilation
• Nocturnal Alveolar Hypoventilation
• Obesity
• Obesity Hypoventilation Syndrome
• Obesity-hypoventilation Syndrome
• Syndrome

Intervention

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

Locations

Country	Name	City	State
France	CHU Angers	Angers
France	CHU Brest	Brest
France	CH Cannes	Cannes
France	CHU Grenoble	Grenoble
France	CHU Reims	Reims
France	CHU Strasbourg	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of obesity-hypoventilation syndrome	partial pressure of carbon dioxide in the arterial blood > 45mmHg	3 years