Obstructive Sleep Apnea, Retinal Vein Occlusion, Retinal Artery Occlusion

Retinal Vascular Occlusion Clinical Trial

Official title:

Obstructive Sleep Apnea, Retinal Vein Occlusion, Retinal Artery Occlusion

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01291862
• Other study ID #: 1-2010-0008
• Status: Recruiting
• Phase: N/A
• First received: February 1, 2011
• Last updated: January 31, 2012
• Start date: June 2010
• Est. completion date: June 2012

Study information

• Verified date: January 2012
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Retinal Artery Occlusion
• Retinal Vascular Occlusion
• Retinal Vein Occlusion
• Sleep Apnea, Obstructive

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Watchpat-100(noninvasive portable sleep monitoring device)	Result Data of Watchpat-100 : apnea-hypopnea index(AHI)	after finishing the tests with Watchpat-100	No
Primary	Berlin questionnaire	Incidence of patients at risk for obstructive sleep apnea according to the Berlin questionnaire	after finishing the Berlin questionnaire	No
Primary	Epworth sleepiness scale	Incidence of patients with daytime sleepiness according to the Epworth sleepiness scale.	after finishing the Epworth sleepiness sclae	No