Clincosm LogoSign in Get a demo

Obesity-hypoventilation in Metabolic Syndrom Patients

Sponsor
SOS Oxygene Mediterranee (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04839419
Collaborator
(none)
400
Enrollment
1
Location
36
Anticipated Duration (Months)
11.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of the study is to determined the prevalence of obesity-hypoventilation syndrome in patients with metabolic syndrom.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    After being informed about the study and potential risks, patient agreed to participate and undergo :

    a functional respiratory exploration, an arterial blood gas analyze, and a polygraphy coupled with a capnography during the same night.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    400 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    PREVALENCE OF OBESITY-HYPOVENTILATION SYNDROME IN PATIENTS WITH METABOLIC SYNDROME
    Actual Study Start Date :
    Aug 1, 2020
    Anticipated Primary Completion Date :
    Aug 1, 2023
    Anticipated Study Completion Date :
    Aug 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Capnia [Up to one mont after inclusion]

      Arterial pression in CO2 and transcutaneous pression in CO2

    2. Arterial pression in CO2 [At the inclusion]

      PaCO2

    Secondary Outcome Measures

    1. BMI [At the inclusion]

      body mass index

    2. Arterial pression in oxygen [At the inclusion]

      PaO2

    3. somnolence [At the inclusion]

      EPWORTH questionnaire

    4. Physical activity level [At the inclusion]

      Ricci&Gagnon questionnaire

    5. Arterial blood bicarbonates [At the inclusion]

      HCO3-

    6. Arterial blood gases [At the inclusion]

      pH

    7. Hemoglobin [At the inclusion]

      Hb

    8. obstructive sleep apnea items [Up to one mont after inclusion]

      Apnea-hypopnea index

    9. Night Oxygen saturation [Up to one mont after inclusion]

      SpO2

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • BMI>30 kg/m2

    • no treatment with CPAP nor NIV

    Exclusion Criteria:

    • obstructive respiratory disease

    • non-treated cardiac dysfunction

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Clinique du Château de Vernhes Bondigoux France 31340

    Sponsors and Collaborators

    • SOS Oxygene Mediterranee

    Investigators

    • Principal Investigator: Mathieu Despeaux, MD, Clinique du Chateau de Vernhes

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    SOS Oxygene Mediterranee
    ClinicalTrials.gov Identifier:
    NCT04839419
    Other Study ID Numbers:
    • 2019-A02866-51
    First Posted:
    Apr 9, 2021
    Last Update Posted:
    Apr 9, 2021
    Last Verified:
    Apr 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Hypoventilation
    Obesity Hypoventilation Syndrome
    Obesity
    Metabolic Syndrome
    Syndrome

    Study Results

    No Results Posted as of Apr 9, 2021