Obstructive Sleep Apnea, Retinal Vein Occlusion, Retinal Artery Occlusion
The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Yonsei University.
Recruitment status was Recruiting
Information provided by (Responsible Party):
First received: February 1, 2011
Last updated: January 31, 2012
Last verified: January 2012
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.
Retinal Vascular Occlusion
Device: Watchpat 100
||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
||Obstructive Sleep Apnea, Retinal Vein Occlusion, Retinal Artery Occlusion
Primary Outcome Measures:
- Watchpat-100(noninvasive portable sleep monitoring device) [ Time Frame: after finishing the tests with Watchpat-100 ] [ Designated as safety issue: No ]
Result Data of Watchpat-100 : apnea-hypopnea index(AHI)
- Berlin questionnaire [ Time Frame: after finishing the Berlin questionnaire ] [ Designated as safety issue: No ]
Incidence of patients at risk for obstructive sleep apnea according to the Berlin questionnaire
- Epworth sleepiness scale [ Time Frame: after finishing the Epworth sleepiness sclae ] [ Designated as safety issue: No ]
Incidence of patients with daytime sleepiness according to the Epworth sleepiness scale.
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||June 2012 (Final data collection date for primary outcome measure)
Device: Watchpat 100
Watchpat 100 is a noninvasive portable sleep monitoring device which monitors peripheral arterial tone, pulse, oxygen saturation, snoring, and body position. Patient places one probe at his or her finger and another sensor at front of the chest and Watchpat 100 monitors the patient overnight.
Other Name: Watch-PAT™ 100
|Ages Eligible for Study:
||20 Years to 70 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Any patient who visits outpatient clinic and diagnosed as retinal vascular occlusion which occurred within recent 3 months
- 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01291862
|Seoul, Korea, Republic of, 120-752 |
|Contact: Won-Kyung Song, MD, Ph.D 82-2-2228-3570 firstname.lastname@example.org |
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||February 1, 2011
||January 31, 2012
||South Korea: Korea Food and Drug Administration (KFDA)
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 01, 2014
Sleep Apnea, Obstructive
Retinal Vein Occlusion
Retinal Artery Occlusion
Sleep Apnea Syndromes
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Nervous System Diseases
Embolism and Thrombosis
Arterial Occlusive Diseases