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

University Hospital, Strasbourg, France

Status: Terminated

Conditions: Obesity-hypoventilation Syndrome; Nocturnal Alveolar Hypoventilation

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02021448

5059

Details and patient eligibility

About

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

Enrollment: 188 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

188 participants in 1 patient group

Obesity: BMI > 30 kg/m2

Other group

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

Treatment:

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