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

NCT00874913 | Unknown

• 1 other identifier: DGS 2006/0052
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea Syndrome

Keywords

blood flow; obstructive sleep apnea syndrome; normal tension glaucoma

Outcome Measures

Primary Outcomes (1)

• ocular blood flow

  9 months

Secondary Outcomes (1)

• comparisons between OSAS patients and healthy controls

  6 years

Study Arms (1)

Laser Doppler Flowmetry

EXPERIMENTAL

Device: measurement of ocular blood flow

Interventions

measurement of ocular blood flow DEVICE

measurement of ocular blood flow with a laser Doppler flowmeter

Laser Doppler Flowmetry

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• the age is between 18 years \& 80 years
• nobody affiliated with social security
• including informed \& signed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

Chu de Grenoble

Grenoble, 38043, France

RECRUITING

Related Publications (2)

• Chiquet C, Lacharme T, Riva C, Almanjoumi A, Aptel F, Khayi H, Arnol N, Romanet JP, Geiser M. Continuous response of optic nerve head blood flow to increase of arterial blood pressure in humans. Invest Ophthalmol Vis Sci. 2014 Jan 23;55(1):485-91. doi: 10.1167/iovs.13-12975.

  PMID: 24355824 DERIVED

• Khayi H, Pepin JL, Geiser MH, Tonini M, Tamisier R, Renard E, Baguet JP, Levy P, Romanet JP, Chiquet C. Choroidal blood flow regulation after posture change or isometric exercise in men with obstructive sleep apnea syndrome. Invest Ophthalmol Vis Sci. 2011 Dec 16;52(13):9489-96. doi: 10.1167/iovs.11-7936.

  PMID: 22025580 DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Low Tension Glaucoma

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Glaucoma; Ocular Hypertension; Eye Diseases; Optic Nerve Diseases

Study Officials

• Jean-Paul Romanet, Professor, MD

  ophthalmology service, university hospital, grenoble

  PRINCIPAL INVESTIGATOR

• Christophe CHIQUET, Professor, MD, PhD

  Ophthalmology service, University hospital, Grenoble

  STUDY CHAIR

• Karine Palombi, Doctor, MD

  ophthalmology service, university hospital, grenoble

  PRINCIPAL INVESTIGATOR

• Elisabeth Renard, Doctor, MD

  ophthalmology service, university hospital, grenoble

  PRINCIPAL INVESTIGATOR

• Jean-Louis Pepin, Professor, MD, PhD

  sleep laboratory, university hospital, grenoble

  STUDY DIRECTOR

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

CHRISTOPHE CHIQUET, MD PHD

CONTACT

33476768457; cchiquet@chu-grenoble.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2009
• First Posted: April 3, 2009
• Study Start: September 1, 2006
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: October 10, 2012

Record last verified: 2012-10

Locations

FR (1)