Circulating Exosomes and Endothelial Dysfunction in Patie... | NCT04459182

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

NCT04459182

Sponsor

University Hospital, Angers

Status

Completed

Last Update Posted

Jun 11, 2024Actual

Enrollment

99Actual

Phase

Not Applicable

Conditions

Endothelial Dysfunction

Interventions

ENDOPAT

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 14, 2021Actual

Primary Completion Date

Jul 6, 2023Actual

Completion Date

Jul 6, 2023Actual

First Submitted Date

Jun 30, 2020

First Submission Date that Met QC Criteria

Jul 3, 2020

First Posted Date

Jul 7, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 10, 2024

Last Update Posted Date

Jun 11, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

99Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Endothelial dysfunction (DE+)	Active Comparator	obsese patient with OSA (AHI>15) and endothelial dysfunction	Diagnostic Test: ENDOPAT
No endothelial dysfunction (DE-)	Sham Comparator	obsese patient with OSA (AHI>15) and no endothelial dysfunction	Diagnostic Test: ENDOPAT

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ENDOPAT	Diagnostic Test	digital plethysmography	Endothelial dysfunction (DE+) No endothelial dysfunction (DE-)

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
GAGNADOUX Frédéric, PhD	University Hospital, Angers	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Frédéric GAGNADOUX		Angers		49933	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided