Circulating Exosomes and Endothelial Dysfunction in Patients With Obstructive Sleep Apneas Hypopneas Syndrome

Overview

Evaluation of miRNA contained in exosomes in obese and OSA patients with endothelial dysfunction evaluated by digital plethysmography (ENDOPAT) compared to obese and OSA patients without endothelial dysfunction.

Full Title of Study: “Circulating Exosomes and Endothelial Dysfunction in Patients With Obstructive Sleep Apneas Hypopneas Syndrome(OSA): EXODYS”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Basic Science
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 30, 2021

Detailed Description

The aim of the study is to compare the content of exosomes between two goups of 20 patients, with and without endothelial dysfucntion. the endothelial function will be evaluated after polysomnography, on obese patients with OSA (AHI >15).

Interventions

  • Diagnostic Test: ENDOPAT
    • digital plethysmography

Arms, Groups and Cohorts

  • Active Comparator: Endothelial dysfunction (DE+)
    • obsese patient with OSA (AHI>15) and endothelial dysfunction
  • Sham Comparator: No endothelial dysfunction (DE-)
    • obsese patient with OSA (AHI>15) and no endothelial dysfunction

Clinical Trial Outcome Measures

Primary Measures

  • miRNA cointained in exosomes
    • Time Frame: immediately after the consultation
    • compare exosome content between obese-OSA patients with endothelial dysfunction and without

Participating in This Clinical Trial

Inclusion Criteria

  • adult subject – Subject understands the study protocol and is willing and able to comply with study requirements and sign informed consent – Subject with OSA (defined by AHI >15/h) Exclusion Criteria:

  • cardiac or vascular desease

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital, Angers
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • GAGNADOUX Frédéric, PhD, Principal Investigator, University Hospital, Angers
  • Overall Contact(s)
    • GAGNADOUX Frédéric, PhD, +33241353695, frgagnadoux@chu-angers.fr

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