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NCT04839419 Clinical Trial

Obesity-hypoventilation in Metabolic Syndrom Patients

Metabolic Syndrome Clinical Trial

Official title:
Prevalence of Obesity-hypoventilation Syndrome in Patients With Metabolic Syndrome.

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04839419
Other study ID # 2019-A02866-51
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 1, 2020
Est. completion date August 1, 2025

Study information
Verified date November 2023
Source SOS Oxygene Mediterranee
Contact Delphine Delample, PhD
Phone 0612155648
Email d.delample@sosoxygene.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 400
Est. completion date August 1, 2025
Est. primary completion date August 1, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - BMI>30 kg/m2 - no treatment with CPAP nor NIV Exclusion Criteria: - obstructive respiratory disease - non-treated cardiac dysfunction

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
France Clinique du Château de Vernhes Bondigoux

Sponsors (1)
Lead Sponsor Collaborator
SOS Oxygene Mediterranee

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Capnia Arterial pression in CO2 and transcutaneous pression in CO2 Up to one mont after inclusion
Primary Arterial pression in CO2 PaCO2 At the inclusion
Secondary BMI body mass index At the inclusion
Secondary Arterial pression in oxygen PaO2 At the inclusion
Secondary somnolence EPWORTH questionnaire; Minimum = 0; Maximum = 24, Higher score means a worth outcome At the inclusion
Secondary Physical activity level Ricci&Gagnon questionnaire, Minimum = 9; Maximum = 45, Higher score means a worth outcome At the inclusion
Secondary Arterial blood bicarbonates HCO3- At the inclusion
Secondary Arterial blood gases pH At the inclusion
Secondary Hemoglobin Hb At the inclusion
Secondary obstructive sleep apnea items Apnea-hypopnea index Up to one mont after inclusion
Secondary Night Oxygen saturation SpO2 Up to one mont after inclusion
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