NCT01188291

Brief Summary

The purpose of this study was to measure the retinal nerve fiber layer (RNFL) thickness in eyes of Obstructive Sleep Apnea/hypopnea syndrome (OSAHS) using optical coherence tomography (OCT), and assess whether it is decreased. The investigators then compared the results with healthy subjects database of RNFL thickness from another retrospective study.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
166

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

August 17, 2010

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 25, 2010

Completed
Last Updated

March 12, 2012

Status Verified

August 1, 2010

Enrollment Period

1.3 years

First QC Date

August 17, 2010

Last Update Submit

March 9, 2012

Conditions

Obstructive Sleep ApneaHypopnea SyndromeGlaucoma

Keywords

Optical Coherence TomographyRetinal Nerve Fiber Layer ThicknessObstructive Sleep ApneaHypopnea syndromeGlaucoma

Outcome Measures

Primary Outcomes (1)

  • Retinal Nerve Fiber Layer Thickness as measured Optical Coherence Tomography, and expressed in micrometers.

    four months

Study Arms (1)

Sleep Apnea / Hypopnea syndrome

Study group composed of patients with Obstructive Sleep Apnea / Hypopnea syndrome

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Study group composed of patients with Obstructive Sleep Apnea / Hypopnea syndrome.

You may qualify if:

  • formal diagnosis of moderate or severe OSAHS
  • eligibility to sign informed consent form
  • older than 18 years

You may not qualify if:

  • known glaucoma
  • not eligible to sign informed consent form
  • younger than 18 years
  • incompetent persons who lack decision making capability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Carmel Medical Center

Haifa, Israel

Location

Related Publications (1)

  • Sagiv O, Fishelson-Arev T, Buckman G, Mathalone N, Wolfson J, Segev E, Peled R, Lavi I, Geyer O. Retinal nerve fibre layer thickness measurements by optical coherence tomography in patients with sleep apnoea syndrome. Clin Exp Ophthalmol. 2014 Mar;42(2):132-8. doi: 10.1111/ceo.12145. Epub 2013 Jul 15.

    PMID: 23777553DERIVED

MeSH Terms

Conditions

Sleep Apnea, ObstructiveGlaucoma

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesOcular HypertensionEye Diseases

Study Officials

  • Orna Geyer, Prof

    Carmel Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 17, 2010

First Posted

August 25, 2010

Study Start

September 1, 2007

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

March 12, 2012

Record last verified: 2010-08

Locations

IL(1)