- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01291862
Obstructive Sleep Apnea, Retinal Vein Occlusion, Retinal Artery Occlusion
January 31, 2012 updated by: Yonsei University
Obstructive sleep apnea is a common disorder linked to serious long-term adverse health consequences; such as hypertension, metabolic dysfunction, cardiovascular disease.
Retinal vascular occlusion is related to many systemic illnesses especially hypertension.
Obstructive sleep apnea is also related to vascular endothelial dysfunction and vascular endothelial growth factor elevation which causes vision threatening complications of retinal vascular occlusion.
Therefore the relationship between obstructive sleep apnea and retinal vascular occlusion should be studied.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Seoul, Korea, Republic of, 120-752
- Recruiting
- Severance Hospital
-
Contact:
- Won-Kyung Song, MD, Ph.D
- Phone Number: 82-2-2228-3570
- Email: songwkmd@yuhs.ac
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Any patient who visits outpatient clinic and diagnosed as retinal vascular occlusion which occurred within recent 3 months
Exclusion Criteria:
- Any ocular disease other than retinal vascular occlusion (for example: floppy eyelid syndrome, uveitis, glaucoma, other retinal diseases)
- Patient who has difficulty answering the questionnaires or portable sleep monitoring
- Patient who refuses the study enroll
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Watchpat-100(noninvasive portable sleep monitoring device)
Time Frame: after finishing the tests with Watchpat-100
|
Result Data of Watchpat-100 : apnea-hypopnea index(AHI)
|
after finishing the tests with Watchpat-100
|
Berlin questionnaire
Time Frame: after finishing the Berlin questionnaire
|
Incidence of patients at risk for obstructive sleep apnea according to the Berlin questionnaire
|
after finishing the Berlin questionnaire
|
Epworth sleepiness scale
Time Frame: after finishing the Epworth sleepiness sclae
|
Incidence of patients with daytime sleepiness according to the Epworth sleepiness scale.
|
after finishing the Epworth sleepiness sclae
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2010
Primary Completion (ANTICIPATED)
June 1, 2012
Study Completion (ANTICIPATED)
June 1, 2012
Study Registration Dates
First Submitted
February 1, 2011
First Submitted That Met QC Criteria
February 8, 2011
First Posted (ESTIMATE)
February 9, 2011
Study Record Updates
Last Update Posted (ESTIMATE)
February 2, 2012
Last Update Submitted That Met QC Criteria
January 31, 2012
Last Verified
January 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Nervous System Diseases
- Respiratory Tract Diseases
- Arterial Occlusive Diseases
- Apnea
- Respiration Disorders
- Sleep Disorders, Intrinsic
- Dyssomnias
- Sleep Wake Disorders
- Eye Diseases
- Retinal Diseases
- Embolism and Thrombosis
- Venous Thrombosis
- Thrombosis
- Sleep Apnea Syndromes
- Sleep Apnea, Obstructive
- Retinal Vein Occlusion
- Retinal Artery Occlusion
Other Study ID Numbers
- 1-2010-0008
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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