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Obstructive Sleep Apnea, Retinal Vein Occlusion, Retinal Artery Occlusion

Primary Purpose

Retinal Vascular Occlusion

Status

Unknown status

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Watchpat 100

About this trial

This is an interventional diagnostic trial for Retinal Vascular Occlusion

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Severance HospitalRecruiting

Outcomes

Primary Outcome Measures

Watchpat-100(noninvasive portable sleep monitoring device)

Result Data of Watchpat-100 : apnea-hypopnea index(AHI)

Berlin questionnaire

Incidence of patients at risk for obstructive sleep apnea according to the Berlin questionnaire

Epworth sleepiness scale

Incidence of patients with daytime sleepiness according to the Epworth sleepiness scale.

Secondary Outcome Measures

Full Information

NCT ID

NCT01291862

First Posted

February 1, 2011

Last Updated

January 31, 2012

Sponsor

Yonsei University

1. Study Identification

Unique Protocol Identification Number

NCT01291862

Brief Title

Obstructive Sleep Apnea, Retinal Vein Occlusion, Retinal Artery Occlusion

Official Title

Obstructive Sleep Apnea, Retinal Vein Occlusion, Retinal Artery Occlusion

Study Type

Interventional

2. Study Status

Record Verification Date

January 2012

Overall Recruitment Status

Unknown status

Study Start Date

June 2010 (undefined)

Primary Completion Date

June 2012 (Anticipated)

Study Completion Date

June 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yonsei University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Retinal Vascular Occlusion

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Device

Intervention Name(s)

Watchpat 100

Other Intervention Name(s)

Watch-PAT™ 100

Intervention Description

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.

Primary Outcome Measure Information:

Title

Watchpat-100(noninvasive portable sleep monitoring device)

Description

Result Data of Watchpat-100 : apnea-hypopnea index(AHI)

Time Frame

after finishing the tests with Watchpat-100

Title

Berlin questionnaire

Description

Incidence of patients at risk for obstructive sleep apnea according to the Berlin questionnaire

Time Frame

after finishing the Berlin questionnaire

Title

Epworth sleepiness scale

Description

Incidence of patients with daytime sleepiness according to the Epworth sleepiness scale.

Time Frame

after finishing the Epworth sleepiness sclae

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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

Facility Information:

Facility Name

Severance Hospital

City

Seoul

ZIP/Postal Code

120-752

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Won-Kyung Song, MD, Ph.D

Phone

82-2-2228-3570

songwkmd@yuhs.ac

12. IPD Sharing Statement

Citations:

PubMed Identifier

27051260

Citation

Kwon HJ, Kang EC, Lee J, Han J, Song WK. Obstructive Sleep Apnea in Patients with Branch Retinal Vein Occlusion: A Preliminary Study. Korean J Ophthalmol. 2016 Apr;30(2):121-6. doi: 10.3341/kjo.2016.30.2.121. Epub 2016 Mar 25.

Results Reference

derived

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Obstructive Sleep Apnea, Retinal Vein Occlusion, Retinal Artery Occlusion

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