NCT01291862

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 1, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 9, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

February 2, 2012

Status Verified

January 1, 2012

Enrollment Period

2 years

First QC Date

February 1, 2011

Last Update Submit

January 31, 2012

Conditions

Outcome Measures

Primary Outcomes (3)

  • Watchpat-100(noninvasive portable sleep monitoring device)

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

    after finishing the tests with Watchpat-100

  • Berlin questionnaire

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

    after finishing the Berlin questionnaire

  • Epworth sleepiness scale

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

    after finishing the Epworth sleepiness sclae

Interventions

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.

Also known as: Watch-PAT™ 100

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Any patient who visits outpatient clinic and diagnosed as retinal vascular occlusion which occurred within recent 3 months

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Severance Hospital

Seoul, 120-752, South Korea

RECRUITING

Related Publications (1)

  • 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.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2011

First Posted

February 9, 2011

Study Start

June 1, 2010

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

February 2, 2012

Record last verified: 2012-01

Locations