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

NCT02021448 | Terminated

• 1 other identifier: 5059
• Study Type: interventional
• Target: 188
• Locations: 1 country
• Sites: 6

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

Conditions

Obesity-hypoventilation Syndrome; Nocturnal Alveolar Hypoventilation

Keywords

OHS

Outcome Measures

Primary Outcomes (1)

• Occurrence of obesity-hypoventilation syndrome

  partial pressure of carbon dioxide in the arterial blood \> 45mmHg

  3 years

Study Arms (1)

Obesity: BMI > 30 kg/m2

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

Other: Annual visits among 3 years. During each visit different testings are performed in order to detect an obesity-hypoventilation syndrome (OHS)

Interventions

Annual visits among 3 years. During each visit different testings are performed in order to detect an obesity-hypoventilation syndrome (OHS) OTHER

Polygraphy/Polysomnography,Blood sampling, EKG,Lung function testing,Arterial blood gases,Thoracic radiography,Six-minute walk test,Respiratory questionnaires

Obesity: BMI > 30 kg/m2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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
• Drug or alcohol abuse
• Pregnancy

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (6)

CHU Angers

Angers, 49000, France

Location

CHU Brest

Brest, 29609, France

Location

CH Cannes

Cannes, 06400, France

Location

CHU Grenoble

Grenoble, 38043, France

Location

CHU Reims

Reims, 51100, France

Location

CHU Strasbourg

Strasbourg, 67091, France

Location

MeSH Terms

Conditions

Obesity Hypoventilation Syndrome

Condition Hierarchy (Ancestors)

Sleep Apnea, Obstructive; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Hypoventilation; Respiratory Insufficiency; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• KESSLER Romain, MD

  University Hospital, Strasbourg, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2013
• First Posted: December 27, 2013
• Study Start: December 1, 2013
• Primary Completion: January 1, 2022
• Study Completion: June 1, 2022
• Last Updated: July 11, 2022

Record last verified: 2022-07

Locations

FR (6)