Study of Ocular Blood Flow in Patients With Glaucoma and/or Obstructive Sleep Apnea Syndrome (OSAS)
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Purpose
Obstructive sleep apnea syndrome (OSAS) is a common disease, with a prevalence evaluated between 5 - 7% in the general population. OSAS is characterized by recurrent episodes of partial or complete upper airway obstruction during sleep, which are nearly systematically associated with a desaturation-reoxygenation sequence, an admitted detrimental stimulus for the cardiovascular system. It has now been demonstrated that OSAS per se is able to generate hypertension, atherosclerosis and autonomic dysfunction (high sympathic tone and increase in baseline heart rate), all conditions possibly interacting with ocular vascular regulation. OSAS has major consequences on the ocular level since it is associated with a higher frequency of optic neuropathies, such as glaucoma and nonarteritic ischemic optic neuropathy (NAION), both with functional severe prognosis. Most of vascular changes associated with OSAS have been studied at the level of macrovasculature. In terms of physiopathology, the main effects on the vascular system in OSAS are sympathetic hyperactivity, oxidative stress, development of endothelial dysfunction, systemic inflammation and metabolic alterations such as the appearance of insulin resistance. All these mechanisms can affect the microcirculation of the eye, especially the optic nerve and choroid. Our hypothesis is that the eye microvasculature is affected by OSAS, and these lesions may be detected via a reduced autoregulation of blood flow in humans.
This project aims to demonstrate, quantify, and analyze the vascular modifications of the eye associated with OSAS trough a comparative clinical study on glaucoma patients and OSAS patients and matched healthy subjects for the regulation of the eye blood flow using confocal laser Doppler flowmetry (LDF). The regulation of the ocular blood flow will be assessed using several stimuli and measured using a new confocal LDF.
| Condition | Intervention |
|---|---|
|
Obstructive Sleep Apnea Syndrome |
Device: measurement of ocular blood flow |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Single Blind (Subject) Primary Purpose: Basic Science |
| Official Title: | Study of Ocular Blood Flow Using Laser Doppler Flowmetry in Patients With Glaucoma and/or OSAS |
- ocular blood flow [ Time Frame: 9 months ] [ Designated as safety issue: No ]
- comparisons between OSAS patients and healthy controls [ Time Frame: 6 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 90 |
| Study Start Date: | September 2006 |
| Estimated Study Completion Date: | January 2014 |
| Estimated Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Laser Doppler Flowmetry |
Device: measurement of ocular blood flow
measurement of ocular blood flow with a laser Doppler flowmeter
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- the age is between 18 years & 80 years
- nobody affiliated with social security
- including informed & signed consent
Exclusion Criteria:
- congenital malformation leading to an excavation of the optic nerve or a deficit of the visual field
- any eye disease associated, including refraction disorder ( > 4 diopters) , retinal disease, cataract, corneal opacity)
- taking medication which can have an action on blood pressure or regulation ( vasoconstrictors, vasodilators, beta-agonists and antagonists, nitrates, theophylline, dipyridamole, sildenafil, immunosuppressive, corticosteroid or Non-steroidal anti-inflammatory drugs (> 10 days), hormonal therapy), sedative drug (antidepressive, anxiolytics, hypnotics) drops with activity on regulation of ocular pressure ( beta-blockers)
- all ophthalmic drops
- pregnancy
- current infection ( acute hepatitis B, hepatitis C active, HIV infection)
- known hypertension or suspected
- Electrolyte disturbance
- Pathology that can affect the regulation of blood pressure : parkinson' disease, patients transplanted kidney or cardiac arrhythmias, severe heart failure atrial fibrillation or frequent extrasystole (> 10 / minute)
- nocturnal Professional activity
- History of surgery or carotid stenting
- Previous treatment of Obstructive Sleep Apnea Syndrome by continuous positive pressure, propulsion prosthesis mandibular or maxillofacial surgery
- No predictable compliance with the protocol
- Patients participating in another biomedical research
- Patients with no affiliation to social security
- narrow irido corneal angle
Contacts and Locations| Contact: CHRISTOPHE CHIQUET, MD PHD | 33476768457 | cchiquet@chu-grenoble.fr |
| France | |
| Chu de Grenoble | Recruiting |
| Grenoble, France, 38043 | |
| Contact: CHRISTOPHE CHIQUET, MD PHD 33476768457 | |
| Principal Investigator: CHRISTOPHE CHIQUET, MD PHD | |
| Principal Investigator: | Jean-Paul Romanet, Professor, MD | ophthalmology service, university hospital, grenoble |
| Study Chair: | Christophe CHIQUET, Professor, MD, PhD | Ophthalmology service, University hospital, Grenoble |
| Principal Investigator: | Karine Palombi, Doctor, MD | ophthalmology service, university hospital, grenoble |
| Principal Investigator: | Elisabeth Renard, Doctor, MD | ophthalmology service, university hospital, grenoble |
| Study Director: | Jean-Louis Pepin, Professor, MD, PhD | sleep laboratory, university hospital, grenoble |
| Principal Investigator: | Patrick Levy, Professor, MD, PhD | sleep laboratory, university hospital, grenoble |
| Principal Investigator: | Renaud Tamisier, Doctor, MD, PhD | sleep laboratory, university hospital, grenoble |
| Principal Investigator: | Jean-Philippe Baguet, Professor, MD, PhD | cardiology service, university hospital, grenoble |
More Information
No publications provided by University Hospital, Grenoble
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | University Hospital, Grenoble |
| ClinicalTrials.gov Identifier: | NCT00874913 History of Changes |
| Other Study ID Numbers: | DGS 2006/0052 |
| Study First Received: | April 2, 2009 |
| Last Updated: | October 8, 2012 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by University Hospital, Grenoble:
|
blood flow obstructive sleep apnea syndrome normal tension glaucoma |
Additional relevant MeSH terms:
|
Apnea Glaucoma Sleep Apnea Syndromes Sleep Apnea, Obstructive Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory |
Signs and Symptoms Ocular Hypertension Eye Diseases Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders Nervous System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013