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

July 7, 2022 updated by: University Hospital, Strasbourg, France
Investigate whether the course of an isolated nocturnal alveolar hypoventilation can predict the future occurrence of obesity-hypoventilation syndrome (OHS) in obese subjects

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

188

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France, 49000
        • CHU Angers
      • Brest, France, 29609
        • Chu Brest
      • Cannes, France, 06400
        • Ch Cannes
      • Grenoble, France, 38043
        • Chu Grenoble
      • Reims, France, 51100
        • CHU Reims
      • Strasbourg, France, 67091
        • CHU Strasbourg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of obesity-hypoventilation syndrome
Time Frame: 3 years
partial pressure of carbon dioxide in the arterial blood > 45mmHg
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Investigators

  • Principal Investigator: KESSLER Romain, MD, University Hospital, Strasbourg, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 1, 2013

Primary Completion (ACTUAL)

January 1, 2022

Study Completion (ACTUAL)

June 1, 2022

Study Registration Dates

First Submitted

August 29, 2013

First Submitted That Met QC Criteria

December 19, 2013

First Posted (ESTIMATE)

December 27, 2013

Study Record Updates

Last Update Posted (ACTUAL)

July 11, 2022

Last Update Submitted That Met QC Criteria

July 7, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5059

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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