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Sponsored by: |
University Hospital, Grenoble |
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Information provided by: | University Hospital, Grenoble |
ClinicalTrials.gov Identifier: | NCT00874913 |
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 |
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Obstructive Sleep Apnea Syndrome |
Device: measurement of ocular blood flow |
Study Type: | Interventional |
Study Design: | Basic Science, Single Blind (Subject), Uncontrolled, Single Group Assignment |
Official Title: | Study of Ocular Blood Flow Using Laser Doppler Flowmetry in Patients With Glaucoma and/or OSAS |
Estimated Enrollment: | 90 |
Study Start Date: | September 2006 |
Estimated Study Completion Date: | June 2011 |
Estimated Primary Completion Date: | June 2007 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
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 |
Responsible Party: | CHU de grenoble ( department of ophthalmology ) |
Study ID Numbers: | DGS 2006/0052 |
Study First Received: | April 2, 2009 |
Last Updated: | April 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00874913 History of Changes |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
blood flow obstructive sleep apnea syndrome normal tension glaucoma |
Sleep Apnea Syndromes Apnea Eye Diseases Sleep Apnea, Obstructive Respiration Disorders Dyssomnias Sleep Disorders |
Sleep Disorders, Intrinsic Signs and Symptoms Respiratory Tract Diseases Glaucoma Signs and Symptoms, Respiratory Ocular Hypertension Hypertension |
Sleep Apnea Syndromes Disease Apnea Eye Diseases Nervous System Diseases Sleep Apnea, Obstructive Respiration Disorders Sleep Disorders Dyssomnias |
Sleep Disorders, Intrinsic Signs and Symptoms Pathologic Processes Respiratory Tract Diseases Glaucoma Syndrome Signs and Symptoms, Respiratory Ocular Hypertension |