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
Sponsor:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01291862
First received: February 1, 2011
Last updated: January 31, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention
Retinal Vascular Occlusion
Device: Watchpat 100

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Obstructive Sleep Apnea, Retinal Vein Occlusion, Retinal Artery Occlusion

Resource links provided by NLM:


Further study details as provided by Yonsei University:

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: 30
Study Start Date: June 2010
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    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
  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01291862

Locations
Korea, Republic of
Severance Hospital Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Won-Kyung Song, MD, Ph.D    82-2-2228-3570    songwkmd@yuhs.ac   
Sponsors and Collaborators
Yonsei University
  More Information

No publications provided

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01291862     History of Changes
Other Study ID Numbers: 1-2010-0008
Study First Received: February 1, 2011
Last Updated: January 31, 2012
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Additional relevant MeSH terms:
Sleep Apnea, Obstructive
Retinal Vein Occlusion
Retinal Artery Occlusion
Sleep Apnea Syndromes
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Retinal Diseases
Eye Diseases
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on October 01, 2014