Obstructive Sleep Apnea SyndromeORNETNCT03979001
Retinal Vascular Network and Obstructive Sleep Apnea
An observational study of Obstructive Sleep Apnea Syndrome, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
Obstructive sleep apnea syndrome (OSA) is thought to lead to systemic vascular lesions that may be preceded by early microvascular lesions in the eyes and in particular in the retina. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea Syndrome
- What is being tested?
- complete ophthalmological examination
- How many people
- 166 participants
- Where
- 1 siteFrance
- Study dates
- 6 Jan 2020to 22 Aug 2024
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients seen for sleep apnea screening by a pulmonologist and referred for polysomnography diagnosis of obstructive sleep apnea syndrome
Who may be able to join
- person who has given oral consent
- person who can be followed throughout the study
- adult
- Patient group:
- Patient seen in sleep apnea screening consultation by a pulmonologist and referred for polysomnography diagnosis of OSA
- Control Group:
- Person initially without obstructive sleep apnea syndrome
Who cannot join
- a person who is not affiliated to or not a beneficiary of the national health insurance system
- person subject to a measure of legal protection (curatorship, guardianship)
- person subject to a safeguard of justice
- pregnant, parturient or breastfeeding woman
- adult incapable or unable to consent
- person with a contraindication to Tropicamide or Neosynephrine
Show all 13Show fewer
- person with a history of eye disease affecting ocular circulation (examples: acute anterior ischemic optic neuropathy, retinal central artery occlusion, retinal central vein occlusion, diabetic retinopathy, glaucoma, uncontrolled hypertonia, AMD, severe myopia...)
- Control Group:
- person with a history of chronic lung problems (e.g. COPD, chronic respiratory failure, etc.)
- person with at least one of the following risk factors for obstructive sleep apnea syndrome:
- Obesity with IMC≥30
- Alcohol consumption > 3 glasses per day
- Exclusion criteria: positive result in one of the 3 self-questionnaires
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study: Retinal Vascular Network and Obstructive Sleep Apnea
Obstructive sleep apnea syndrome (OSA) is thought to lead to systemic vascular lesions that may be preceded by early microvascular lesions in the eyes and in particular in the retina. The improvement of ophthalmological imaging techniques by OCTangiography allows a precise non-invasive study of the retinal microvascular network. This new rapid and non-invasive retinal imaging tool could reveal micro-vascular lesions related to OSA. To the investigator's knowledge, this would be the first OCT-angiography description of a cohort of patients with OSA. If these results are confirmed, it would be interesting to study the correlation between these micro-vascular lesions and the cardiovascular risk of his patients.
- Conditions
- Obstructive Sleep Apnea Syndrome
- Being tested
- complete ophthalmological examination
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
complete ophthalmological examinationOther
collection:
- ophthalmological history and current treatments
- occular tension measurement
- measurement of visual acuity (Snellen chart)
- Axial length measurement
- Photograph of the posterior segment of the eye
- 3x3 and 6x6 macular and papillary OCT angiography
| Study group | Role | What they receive |
|---|---|---|
| Patients | Patients referred for polysomnography diagnosis of obstructive sleep apnea syndrome Receives: Other: complete ophthalmological examination | |
| Controls | Person without obstructive sleep apnea syndrome |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of macular and peri-papillary retinal vascular density of the superficial and deep capillary plexuses
Measured: Change from baseline at 24 months
Measurement of macular and peri-papillary retinal infusion density of the superficial and deep capillary plexuses
Measured: Change from baseline at 24 months
Measurement of the surface of the macular avascular zone of the superficial and deep capillary plexuses
Measured: Change from baseline at 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2019
- Study start6 Jan 2020
- Primary completion22 Aug 2024
- Study completion22 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep Apnea SyndromeStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03979001
- Sponsor's protocol ID
- GABRIELLE 2018
- Acronym
- ORNET
- Status last verified
- Feb 2026
- First submitted
- 5 Jun 2019
- Last updated
- 17 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Germanese C, Georges M, Bonniaud P, Goueslard K, Arnould L, Creuzot Garcher C, Gabrielle PH. Characterization of Retinal Microvascular Changes in Obstructive Sleep Apnea Using OCT Angiography: Data from the Obstructive Sleep Apnea and Retinal Microvascular NETwork Study. Ophthalmology. 2026 Jun;133(6):742-754. doi: 10.1016/j.ophtha.2026.01.030. Epub 2026 Feb 2.
PubMed 41638537
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study: Retinal Vascular Network and Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT03979001
- Acronym / sponsor ID
- ORNET / GABRIELLE 2018
- Conditions
- Obstructive Sleep Apnea Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 6 Jan 2020 (actual)
- Primary completion
- 22 Aug 2024 (actual)
- Study completion
- 22 Aug 2024 (actual)
- First posted
- 7 Jun 2019 (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.
Obstructive sleep apnea syndrome (OSA) is thought to lead to systemic vascular lesions that may be preceded by early microvascular lesions in the eyes and in particular in the retina. The improvement of ophthalmological imaging techniques by OCTangiography allows a precise non-invasive study of the retinal microvascular network. This new rapid and non-invasive retinal imaging tool could reveal micro-vascular lesions related to OSA. To the investigator's knowledge, this would be the first OCT-angiography description of a cohort of patients with OSA. If these results are confirmed, it would be interesting to study the correlation between these micro-vascular lesions and the cardiovascular risk of his patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: complete ophthalmological examinationPatients referred for polysomnography diagnosis of obstructive sleep apnea syndrome |
| Controls | – | –Person without obstructive sleep apnea syndrome |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients seen for sleep apnea screening by a pulmonologist and referred for polysomnography diagnosis of obstructive sleep apnea syndrome
Key inclusion criteria (7 listed)
- person who has given oral consent
- person who can be followed throughout the study
- adult
- Patient seen in sleep apnea screening consultation by a pulmonologist and referred for polysomnography diagnosis of OSA
- Person initially without obstructive sleep apnea syndrome
Key exclusion criteria (13 listed)
- a person who is not affiliated to or not a beneficiary of the national health insurance system
- person subject to a measure of legal protection (curatorship, guardianship)
- person subject to a safeguard of justice
- pregnant, parturient or breastfeeding woman
- adult incapable or unable to consent
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 |
|---|---|---|
| complete ophthalmological examinationcollection: * ophthalmological history and current treatments * occular tension measurement * measurement of visual acuity (Snellen chart) * Axial length measurement * Photograph of the posterior segment of the eye * 3x3 and 6x6 macular and papillary OCT angiography | Other | Patients |
Primary outcome
Measurement of macular and peri-papillary retinal vascular density of the superficial and deep capillary plexuses
Time frame: Change from baseline at 24 months
Measurement of macular and peri-papillary retinal infusion density of the superficial and deep capillary plexuses
Time frame: Change from baseline at 24 months
Measurement of the surface of the macular avascular zone of the superficial and deep capillary plexuses
Time frame: Change from baseline at 24 months
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 17 Feb 2026.
- Results publication: PubMed 41638537Germanese C, Georges M, Bonniaud P, Goueslard K, Arnould L, Creuzot Garcher C, Gabrielle PH. Characterization of Retinal Microvascular Changes in Obstructive Sleep Apnea Using OCT Angiography: Data from the Obstructive Sleep Apnea and Retinal Microvascular NETwork Study. Ophthalmology. 2026 Jun;133(6):742-754. doi: 10.1016/j.ophtha.2026.01.030. Epub 2026 Feb 2.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea Syndrome, run by Centre Hospitalier Universitaire Dijon 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 7 inclusion and 13 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 17 Feb 2026. 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. 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?
Measurement of macular and peri-papillary retinal vascular density of the superficial and deep capillary plexuses (time frame: Change from baseline at 24 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03979001, which also lists 1 linked publication.
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 17 Feb 2026.