Obstructive Sleep ApneaNCT01188291
Retinal Nerve Fiber Layer Thickness Measurements in Patients With Sleep Apnea Syndrome
An observational study of Obstructive Sleep Apnea and Hypopnea Syndrome, run by Carmel Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea, Hypopnea Syndrome, Glaucoma
- How many people
- 166 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2007to Jan 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study group composed of patients with Obstructive Sleep Apnea / Hypopnea syndrome.
Who may be able to join
- formal diagnosis of moderate or severe OSAHS
- eligibility to sign informed consent form
- older than 18 years
Who cannot join
- known glaucoma
- not eligible to sign informed consent form
- younger than 18 years
- incompetent persons who lack decision making capability
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retinal Nerve Fiber Layer Thickness Measurements Using Optical Coherence Tomography in Patients With Sleep Apnea Syndrome
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.
Read the detailed description
An association between glaucoma and OSAHS has been reported in several studies. Glaucoma is a progressive optic neuropathy involving loss of retinal ganglion cells and their axons at the level of the optic nerve head.Computerized technologies have now been successfully used in evaluating retinal nerve fiber layer (RNFL) thickness in glaucoma.Given the evidence of a possible link between OSAHS and glaucoma, it is reasonable that structural losses in retinal nerve fiber layer (RNFL) thickness would be present in OSAHS.Indeed,decreased retinal nerve fiber layers was found in patients with OSAHS, the severity of which correlated with the severity of the patients' OSAHS using scanning laser Polarimetry (SLP).Optical coherence tomography (OCT) provides quantitative RNFL thickness data by measuring the difference in the temporal delay of back-scattered light from the RNFL and a reference mirror.During the past decade, OCT has been used widely in clinical practice to discriminate glaucomatous eyes and eyes with early perimetric glaucoma from normal eyes. Several studies confirmed the accuracy and reproducibility of the RNFL thickness measurements by OCT. The thickness of the peripapillary RNFL was measured with the Stratus OCT(Carl Zeiss Meditec, Inc, Dublin,CA)using the fast scan protocol(3.4).Only good quality images, as judged by the well-focused and centered scans,no artifacts showing distorted anatomy, no missing parts and a signal strength ≥6, were used for further analysis. The considered OCT parameters were overall average RNFL thickness and the average RNFL thickness in 4 quadrants (superior, nasal,inferior,and temporal)extracted from the standard RNFL thickness analysis report(RNFL Thickness Average Analysis Protocol).
- Conditions
- Obstructive Sleep Apnea, Hypopnea Syndrome, Glaucoma
- Keywords
- Optical Coherence Tomography, Retinal Nerve Fiber Layer Thickness, Obstructive Sleep Apnea, Hypopnea syndrome, Glaucoma
- Medical subject headings
- Sleep Apnea, Obstructive, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Sleep Apnea / Hypopnea syndrome | Study group composed of patients with Obstructive Sleep Apnea / Hypopnea syndrome |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retinal Nerve Fiber Layer Thickness as measured Optical Coherence Tomography, and expressed in micrometers.
Measured: four months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2010 (estimated)
- Study startSep 2007
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carmel Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Orna Geyer, Carmel Medical Center
- Investigators
- Orna Geyer, Prof, Principal investigator, Carmel Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01188291
- Sponsor's protocol ID
- CMC070029CTIL
- Status last verified
- Aug 2010
- First submitted
- 17 Aug 2010
- Last updated
- 12 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23777553
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retinal Nerve Fiber Layer Thickness Measurements Using Optical Coherence Tomography in Patients With Sleep Apnea Syndrome
- ClinicalTrials.gov ID
- NCT01188291
- Acronym / sponsor ID
- CMC070029CTIL
- Conditions
- Obstructive Sleep Apnea, Hypopnea Syndrome, Glaucoma
- Keywords
- Optical Coherence Tomography, Retinal Nerve Fiber Layer Thickness, Obstructive Sleep Apnea, Hypopnea syndrome, Glaucoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- Carmel Medical CenterUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 25 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
An association between glaucoma and OSAHS has been reported in several studies. Glaucoma is a progressive optic neuropathy involving loss of retinal ganglion cells and their axons at the level of the optic nerve head.Computerized technologies have now been successfully used in evaluating retinal nerve fiber layer (RNFL) thickness in glaucoma.Given the evidence of a possible link between OSAHS and glaucoma, it is reasonable that structural losses in retinal nerve fiber layer (RNFL) thickness would be present in OSAHS.Indeed,decreased retinal nerve fiber layers was found in patients with OSAHS, the severity of which correlated with the severity of the patients' OSAHS using scanning laser Polarimetry (SLP).Optical coherence tomography (OCT) provides quantitative RNFL thickness data by measuring the difference in the temporal delay of back-scattered light from the RNFL and a reference mirror.During the past decade, OCT has been used widely in clinical practice to discriminate glaucomatous eyes and eyes with early perimetric glaucoma from normal eyes. Several studies confirmed the accuracy and reproducibility of the RNFL thickness measurements by OCT. The thickness of the peripapillary RNFL was measured with the Stratus OCT(Carl Zeiss Meditec, Inc, Dublin,CA)using the fast scan protocol(3.4).Only good quality images, as judged by the well-focused and centered scans,no artifacts showing distorted anatomy, no missing parts and a signal strength ≥6, were used for further analysis. The considered OCT parameters were overall average RNFL thickness and the average RNFL thickness in 4 quadrants (superior, nasal,inferior,and temporal)extracted from the standard RNFL thickness analysis report(RNFL Thickness Average Analysis Protocol).
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sleep Apnea / Hypopnea syndrome | – | –Study group composed of patients with Obstructive Sleep Apnea / Hypopnea syndrome |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study group composed of patients with Obstructive Sleep Apnea / Hypopnea syndrome.
Key inclusion criteria (3 listed)
- formal diagnosis of moderate or severe OSAHS
- eligibility to sign informed consent form
- older than 18 years
Key exclusion criteria (4 listed)
- known glaucoma
- not eligible to sign informed consent form
- younger than 18 years
- incompetent persons who lack decision making capability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Retinal Nerve Fiber Layer Thickness as measured Optical Coherence Tomography, and expressed in micrometers.
Time frame: four months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2012.
- Derived from this study: PubMed 23777553Sagiv 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Orna Geyer, Prof principal investigator
Carmel Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea and Hypopnea Syndrome, run by Carmel Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retinal Nerve Fiber Layer Thickness as measured Optical Coherence Tomography, and expressed in micrometers. (time frame: four months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01188291, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2012.