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Study of Ocular Blood Flow in Patients With Glaucoma and/or Obstructive Sleep Apnea Syndrome (OSAS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00874913
Recruitment Status : Unknown
Verified October 2012 by University Hospital, Grenoble.
Recruitment status was:  Recruiting
First Posted : April 3, 2009
Last Update Posted : October 10, 2012
Information provided by (Responsible Party):
University Hospital, Grenoble

Brief Summary:

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 or disease Intervention/treatment Phase
Obstructive Sleep Apnea Syndrome Device: measurement of ocular blood flow Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Study of Ocular Blood Flow Using Laser Doppler Flowmetry in Patients With Glaucoma and/or OSAS
Study Start Date : September 2006
Estimated Primary Completion Date : January 2014
Estimated Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Laser Doppler Flowmetry Device: measurement of ocular blood flow
measurement of ocular blood flow with a laser Doppler flowmeter

Primary Outcome Measures :
  1. ocular blood flow [ Time Frame: 9 months ]

Secondary Outcome Measures :
  1. comparisons between OSAS patients and healthy controls [ Time Frame: 6 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. the age is between 18 years & 80 years
  2. nobody affiliated with social security
  3. including informed & signed consent

Exclusion Criteria:

  1. congenital malformation leading to an excavation of the optic nerve or a deficit of the visual field
  2. any eye disease associated, including refraction disorder ( > 4 diopters) , retinal disease, cataract, corneal opacity)
  3. 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)
  4. all ophthalmic drops
  5. pregnancy
  6. current infection ( acute hepatitis B, hepatitis C active, HIV infection)
  7. known hypertension or suspected
  8. Electrolyte disturbance
  9. 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)
  10. nocturnal Professional activity
  11. History of surgery or carotid stenting
  12. Previous treatment of Obstructive Sleep Apnea Syndrome by continuous positive pressure, propulsion prosthesis mandibular or maxillofacial surgery
  13. No predictable compliance with the protocol
  14. Patients participating in another biomedical research
  15. Patients with no affiliation to social security
  16. narrow irido corneal angle

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00874913

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Contact: CHRISTOPHE CHIQUET, MD PHD 33476768457

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Chu de Grenoble Recruiting
Grenoble, France, 38043
Contact: CHRISTOPHE CHIQUET, MD PHD    33476768457      
Principal Investigator: CHRISTOPHE CHIQUET, MD PHD         
Sponsors and Collaborators
University Hospital, Grenoble
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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
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: University Hospital, Grenoble Identifier: NCT00874913    
Other Study ID Numbers: DGS 2006/0052
First Posted: April 3, 2009    Key Record Dates
Last Update Posted: October 10, 2012
Last Verified: October 2012
Keywords provided by University Hospital, Grenoble:
blood flow
obstructive sleep apnea syndrome
normal tension glaucoma
Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Ocular Hypertension
Eye Diseases