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出境医 / 临床实验 / Retinal Vascular Network and Obstructive Sleep Apnea (ORNET)
Retinal Vascular Network and Obstructive Sleep Apnea (ORNET)
Study Description
Brief 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. 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.
| Condition or disease | Intervention/treatment |
|---|---|
| Obstructive Sleep Apnea Syndrome | Other: complete ophthalmological examination |
Study Design
| Study Type : | Observational |
| Estimated Enrollment : | 180 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Pilot Study: Retinal Vascular Network and Obstructive Sleep Apnea |
| Actual Study Start Date : | January 6, 2020 |
| Estimated Primary Completion Date : | September 2023 |
| Estimated Study Completion Date : | September 2023 |
Arms and Interventions
| Group/Cohort | Intervention/treatment |
|---|---|
|
Patients
Patients referred for polysomnography diagnosis of obstructive sleep apnea syndrome
|
Other: complete ophthalmological examination
collection:
|
|
Controls
Person without obstructive sleep apnea syndrome
|
Outcome Measures
Primary Outcome Measures :
- 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 ]
Eligibility Criteria
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients seen for sleep apnea screening by a pulmonologist and referred for polysomnography diagnosis of obstructive sleep apnea syndrome
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Contacts and Locations
Contacts
| Contact: Pierre-Henry GABRIELLE | 03.80.29.37.56 | phgabrielle@gmail.com |
Locations
| France | |
| Chu Dijon Bourogne | Recruiting |
| Dijon, France, 21000 | |
| Contact: Pierre-Henry Gabrielle 03.80.29.37.56 phgabrielle@gmail.com | |
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | June 5, 2019 | ||||
| First Posted Date | June 7, 2019 | ||||
| Last Update Posted Date | January 20, 2021 | ||||
| Actual Study Start Date | January 6, 2020 | ||||
| Estimated Primary Completion Date | September 2023 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
|
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| Original Primary Outcome Measures |
|
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| Change History | |||||
| Current Secondary Outcome Measures | Not Provided | ||||
| Original Secondary Outcome Measures | Not Provided | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Retinal Vascular Network and Obstructive Sleep Apnea | ||||
| Official Title | Pilot Study: Retinal Vascular Network and Obstructive Sleep Apnea | ||||
| Brief 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. 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. | ||||
| Detailed Description | Not Provided | ||||
| Study Type | Observational | ||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Patients seen for sleep apnea screening by a pulmonologist and referred for polysomnography diagnosis of obstructive sleep apnea syndrome | ||||
| Condition | Obstructive Sleep Apnea Syndrome | ||||
| Intervention | Other: complete ophthalmological examination
collection:
|
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| Study Groups/Cohorts |
|
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| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Recruiting | ||||
| Estimated Enrollment |
180 | ||||
| Original Estimated Enrollment | Same as current | ||||
| Estimated Study Completion Date | September 2023 | ||||
| Estimated Primary Completion Date | September 2023 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
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 Exclusion Criteria:
Control Group:
Exclusion criteria: positive result in one of the 3 self-questionnaires |
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| Sex/Gender |
|
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| Ages | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts |
|
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| Listed Location Countries | France | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03979001 | ||||
| Other Study ID Numbers | GABRIELLE 2018 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| U.S. FDA-regulated Product |
|
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| IPD Sharing Statement | Not Provided | ||||
| Responsible Party | Centre Hospitalier Universitaire Dijon | ||||
| Study Sponsor | Centre Hospitalier Universitaire Dijon | ||||
| Collaborators | Not Provided | ||||
| Investigators | Not Provided | ||||
| PRS Account | Centre Hospitalier Universitaire Dijon | ||||
| Verification Date | January 2021 | ||||
