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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2012 by University Hospital, Grenoble.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT00874913
First received: April 2, 2009
Last updated: October 8, 2012
Last verified: October 2012
  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

Resource links provided by NLM:


Further study details as provided by University Hospital, Grenoble:

Primary Outcome Measures:
  • ocular blood flow [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00874913

Contacts
Contact: CHRISTOPHE CHIQUET, MD PHD 33476768457 cchiquet@chu-grenoble.fr

Locations
France
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
Investigators
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
Syndrome
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
Disease
Pathologic Processes

ClinicalTrials.gov processed this record on October 02, 2014