Obstructive Sleep Apnea SyndromeNCT00313092
Obstructive Sleep Apnea Syndrome in Glaucoma
An observational study of Obstructive Sleep Apnea Syndrome and Glaucoma, run by Selim Orguel at 1 site in Switzerland.
Trial summary
The aim of the study is to determine if plasma matrix-metalloproteinase activity can predict glaucoma in patients with OSAS and if the level of plasma matrix-metalloproteinase activity will decrease after one month of nCPAP-treatment. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Obstructive Sleep Apnea Syndrome, Glaucoma
- What is being tested?
- nCPAP treatment
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2005to Sep 2005
- 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 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with sleep apnoe syndrom
Who may be able to join
- OSAS planned begin of a nCPAP treatment
Who cannot join
- Current malignancy
- Oral steroids
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Basel, Eye Clinic
Basel, Canton of Basel-City, 4031
About this study
Official title: Does Plasma Matrix-metalloproteinase Activity Predict Glaucomas in Patients With OSAS (Obstructive Sleep Apnea Syndrome) and Does the Level of Plasma Matrix-metalloproteinase Activity Decrease After One Month of nCPAP-treatment
The aim of the study is to determine if plasma matrix-metalloproteinase activity can predict glaucoma in patients with OSAS and if the level of plasma matrix-metalloproteinase activity will decrease after one month of nCPAP-treatment.
Read the detailed description
Glaucoma is a leading cause of blindness world-wide. Chronic primary open-angle glaucoma is the most common form among Caucasian patients. The key feature of glaucoma is damage to the optic nerve head, which is not necessarily related to an increased intraocular pressure. The prevalence of glaucoma among the patients with sleep apnoea was 7,2%: normal-tension glaucoma 2,9%, primary open-angle glaucoma 4,3%. The prevalence of obstructive sleep apnoea syndrome (OSAS) is around 4-10% for men and 2-4% for women. Matrix metalloproteinases (MMPs) substrates include essentially all extracellular matrix components as well as a wide array of molecules involved in intracellular adhesion, cell-matrix interaction, and cell signalling. However, MMPs effects are not restricted to extracellular matrix degradation. The prevalence of increased MMP in patients with OSAS and its predicting value for an additional glaucoma are not known. Further, we do not know if treatment of OSAS with nasal continuous positive air pressure(nCPAP) can decrease the MMP activity. With this study, we want to determine the prevalence of MMP activity and the prevalence of glaucoma in patients with OSAS. Further, we want to investigate if a nCPAP treatment period of four weeks decreases the MMP activity.
- Conditions
- Obstructive Sleep Apnea Syndrome, Glaucoma
- Being tested
- nCPAP treatment
- Keywords
- OSAS, glaucoma, MMP
- 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.
nCPAP treatmentDevice
treatment with positive air pressure during night
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2006 (estimated)
- Study startJan 2005
- Primary completionSep 2005
- Study completionSep 2005
Why it stopped: recruiting problems
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep Apnea SyndromeStudies 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
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selim Orguel
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Basel, Switzerland
- Responsible party
- Sponsor-investigator, Selim Orguel, University Hospital, Basel, Switzerland
- Investigators
- Selim Orgül, MD, Study director, University Eye Clinic Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00313092
- Sponsor's protocol ID
- 045-LEJ-2004-002
- Status last verified
- Oct 2015
- First submitted
- 10 Apr 2006
- Last updated
- 2 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Plasma Matrix-metalloproteinase Activity Predict Glaucomas in Patients With OSAS (Obstructive Sleep Apnea Syndrome) and Does the Level of Plasma Matrix-metalloproteinase Activity Decrease After One Month of nCPAP-treatment
- ClinicalTrials.gov ID
- NCT00313092
- Acronym / sponsor ID
- 045-LEJ-2004-002
- Conditions
- Obstructive Sleep Apnea Syndrome, Glaucoma
- Keywords
- OSAS, glaucoma, MMP
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: recruiting problems
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Selim OrguelUniversity, hospital or other
- Collaborators
- University Hospital, Basel, Switzerland
- Study start
- Jan 2005
- Primary completion
- Sep 2005 (actual)
- Study completion
- Sep 2005 (actual)
- First posted
- 11 Apr 2006 (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 aim of the study is to determine if plasma matrix-metalloproteinase activity can predict glaucoma in patients with OSAS and if the level of plasma matrix-metalloproteinase activity will decrease after one month of nCPAP-treatment.
Detailed description
Glaucoma is a leading cause of blindness world-wide. Chronic primary open-angle glaucoma is the most common form among Caucasian patients. The key feature of glaucoma is damage to the optic nerve head, which is not necessarily related to an increased intraocular pressure. The prevalence of glaucoma among the patients with sleep apnoea was 7,2%: normal-tension glaucoma 2,9%, primary open-angle glaucoma 4,3%. The prevalence of obstructive sleep apnoea syndrome (OSAS) is around 4-10% for men and 2-4% for women. Matrix metalloproteinases (MMPs) substrates include essentially all extracellular matrix components as well as a wide array of molecules involved in intracellular adhesion, cell-matrix interaction, and cell signalling. However, MMPs effects are not restricted to extracellular matrix degradation. The prevalence of increased MMP in patients with OSAS and its predicting value for an additional glaucoma are not known. Further, we do not know if treatment of OSAS with nasal continuous positive air pressure(nCPAP) can decrease the MMP activity. With this study, we want to determine the prevalence of MMP activity and the prevalence of glaucoma in patients with OSAS. Further, we want to investigate if a nCPAP treatment period of four weeks decreases the MMP activity.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with sleep apnoe syndrom
Key inclusion criteria (1 listed)
- OSAS planned begin of a nCPAP treatment
Key exclusion criteria (2 listed)
- Current malignancy
- Oral steroids
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nCPAP treatmenttreatment with positive air pressure during night | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: recruiting problems). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2015.
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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.
Selim Orgül, MD study director
University Eye Clinic Basel
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 Syndrome and Glaucoma, run by Selim Orguel at 1 site in Switzerland.
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 1 inclusion and 2 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: stopped early, as of the sponsor's last update on 2 Oct 2015. 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 Switzerland. 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 was stopped early (reason given: recruiting problems). Results are not available in the source record.
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.
Where can I read the original study information?
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 2 Oct 2015; AzTrials last refreshed its copy on 30 Oct 2026.