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CompletedNCT04459182EXODYSUpdated Jun 11, 2024

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

An interventional study of ENDOPAT in Endothelial Dysfunction, sponsored by University Hospital, Angers. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-11.

Sponsored by University Hospital, Angers · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
99
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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).

02

Conditions studied

  • Endothelial Dysfunction
03

In context

Sleep Apnea, Obstructive

2,198 studies on the registry are indexed under Sleep Apnea, Obstructive; 470 are open to participants now.

This study's enrollment of 99 is above the median of 53 across 1,448 interventional studies indexed under Sleep Apnea, Obstructive.

Browse Sleep Apnea, Obstructive studies →

Lead sponsor

University Hospital, Angers is the lead sponsor of 464 studies on the registry; 116 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • cardiac or vascular desease
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
99 participants (actual)

Study arms

  • Active comparator
    Endothelial dysfunction (DE+)

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

    Diagnostic Test: ENDOPAT

  • Sham comparator
    No endothelial dysfunction (DE-)

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

    Diagnostic Test: ENDOPAT

Interventions

  • Diagnostic testENDOPAT

    digital plethysmography

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What researchers measure

Primary outcomes

  1. miRNA cointained in exosomes

    compare exosome content between obese-OSA patients with endothelial dysfunction and without

    Time frame: immediately after the consultation

07

Study locations

1 site
  • Frédéric GAGNADOUX
    Angers, 49933, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 11, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04459182
Lead sponsor
University Hospital, Angers
Responsible party
Sponsor
First posted
Jul 7, 2020
Start date
Jan 14, 2021
Primary completion
Jul 6, 2023
Completion
Jul 6, 2023
Last update
Jun 11, 2024

Study contacts

GAGNADOUX Frédéric, PhD
principal investigator · University Hospital, Angers

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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