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

NCT ID: NCT04459182

Last Updated: 2024-06-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-14

Study Completion Date

2023-07-06

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Endothelial Dysfunction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Endothelial dysfunction (DE+)

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

Group Type ACTIVE_COMPARATOR

ENDOPAT

Intervention Type DIAGNOSTIC_TEST

digital plethysmography

No endothelial dysfunction (DE-)

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

Group Type SHAM_COMPARATOR

ENDOPAT

Intervention Type DIAGNOSTIC_TEST

digital plethysmography

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ENDOPAT

digital plethysmography

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Angers

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

GAGNADOUX Frédéric, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Angers

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Frédéric GAGNADOUX

Angers, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2020-A01855-34

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

XOR Levels in OSA Patients (XOR-OSA)
NCT06554496 RECRUITING NA