Endothelial DysfunctionEXODYSNCT04459182
Circulating Exosomes and Endothelial Dysfunction in Patients With Obstructive Sleep Apneas Hypopneas Syndrome
A study testing ENDOPAT in people with Endothelial Dysfunction, run by University Hospital, Angers at 1 site in France.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endothelial Dysfunction
- What is being tested?
- ENDOPAT
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 99 participants
- Where
- 1 siteFrance
- Study dates
- 14 Jan 2021to 6 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- cardiac or vascular desease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Circulating Exosomes and Endothelial Dysfunction in Patients With Obstructive Sleep Apneas Hypopneas Syndrome(OSA): EXODYS
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).
- Conditions
- Endothelial Dysfunction
- Being tested
- ENDOPAT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ENDOPATDiagnostic test
digital plethysmography
| Study group | Role | What they receive |
|---|---|---|
| Endothelial dysfunction (DE+) | Active comparator | obsese patient with OSA (AHI>15) and endothelial dysfunction Receives: Diagnostic Test: ENDOPAT |
| No endothelial dysfunction (DE-) | Sham comparator | obsese patient with OSA (AHI>15) and no endothelial dysfunction Receives: Diagnostic Test: ENDOPAT |
What is being measured
The primary outcome is the main question the study is designed to answer.
miRNA cointained in exosomes
compare exosome content between obese-OSA patients with endothelial dysfunction and without
Measured: immediately after the consultation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start14 Jan 2021
- Primary completion6 Jul 2023
- Study completion6 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endothelial DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- GAGNADOUX Frédéric, PhD, Principal investigator, University Hospital, Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04459182
- Sponsor's protocol ID
- 2020-A01855-34
- Acronym
- EXODYS
- Status last verified
- Jun 2024
- First submitted
- 30 Jun 2020
- Last updated
- 11 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circulating Exosomes and Endothelial Dysfunction in Patients With Obstructive Sleep Apneas Hypopneas Syndrome(OSA): EXODYS
- ClinicalTrials.gov ID
- NCT04459182
- Acronym / sponsor ID
- EXODYS / 2020-A01855-34
- Conditions
- Endothelial Dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 14 Jan 2021 (actual)
- Primary completion
- 6 Jul 2023 (actual)
- Study completion
- 6 Jul 2023 (actual)
- First posted
- 7 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endothelial dysfunction (DE+) | Active comparator | Diagnostic Test: ENDOPATobsese patient with OSA (AHI>15) and endothelial dysfunction |
| No endothelial dysfunction (DE-) | Sham comparator | Diagnostic Test: ENDOPATobsese patient with OSA (AHI>15) and no endothelial dysfunction |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (1 listed)
- cardiac or vascular desease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ENDOPATdigital plethysmography | Diagnostic test | Endothelial dysfunction (DE+), No endothelial dysfunction (DE-) |
Primary outcome
miRNA cointained in exosomes
Time frame: immediately after the consultation
compare exosome content between obese-OSA patients with endothelial dysfunction and without
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GAGNADOUX Frédéric, PhD principal investigator
University Hospital, Angers
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ENDOPAT in people with Endothelial Dysfunction, run by University Hospital, Angers at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
miRNA cointained in exosomes (time frame: immediately after the consultation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2024; AzTrials last refreshed its copy on 30 Oct 2026.