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

Primary Purpose

Endothelial Dysfunction

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
ENDOPAT
Sponsored by
University Hospital, Angers
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Endothelial Dysfunction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Frédéric GAGNADOUX

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Endothelial dysfunction (DE+)

No endothelial dysfunction (DE-)

Arm Description

obsese patient with OSA (AHI>15) and endothelial dysfunction

obsese patient with OSA (AHI>15) and no endothelial dysfunction

Outcomes

Primary Outcome Measures

miRNA cointained in exosomes
compare exosome content between obese-OSA patients with endothelial dysfunction and without

Secondary Outcome Measures

Full Information

First Posted
June 30, 2020
Last Updated
July 28, 2023
Sponsor
University Hospital, Angers
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1. Study Identification

Unique Protocol Identification Number
NCT04459182
Brief Title
Circulating Exosomes and Endothelial Dysfunction in Patients With Obstructive Sleep Apneas Hypopneas Syndrome
Acronym
EXODYS
Official Title
Circulating Exosomes and Endothelial Dysfunction in Patients With Obstructive Sleep Apneas Hypopneas Syndrome(OSA): EXODYS
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
January 14, 2021 (Actual)
Primary Completion Date
July 6, 2023 (Actual)
Study Completion Date
July 6, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Angers

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endothelial Dysfunction

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
99 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Endothelial dysfunction (DE+)
Arm Type
Active Comparator
Arm Description
obsese patient with OSA (AHI>15) and endothelial dysfunction
Arm Title
No endothelial dysfunction (DE-)
Arm Type
Sham Comparator
Arm Description
obsese patient with OSA (AHI>15) and no endothelial dysfunction
Intervention Type
Diagnostic Test
Intervention Name(s)
ENDOPAT
Intervention Description
digital plethysmography
Primary Outcome Measure Information:
Title
miRNA cointained in exosomes
Description
compare exosome content between obese-OSA patients with endothelial dysfunction and without
Time Frame
immediately after the consultation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GAGNADOUX Frédéric, PhD
Organizational Affiliation
University Hospital, Angers
Official's Role
Principal Investigator
Facility Information:
Facility Name
Frédéric GAGNADOUX
City
Angers
ZIP/Postal Code
49933
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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