Retinal Vascular OcclusionNCT01291862
Obstructive Sleep Apnea, Retinal Vein Occlusion, Retinal Artery Occlusion
A study testing Watchpat 100 in people with Retinal Vascular Occlusion, run by Yonsei University at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Retinal Vascular Occlusion
- What is being tested?
- Watchpat 100
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2010to Jun 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any patient who visits outpatient clinic and diagnosed as retinal vascular occlusion which occurred within recent 3 months
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Severance Hospital
Seoul, 120-752
Won-Kyung Song, MD, Ph.D, 82-2-2228-3570, songwkmd@yuhs.ac
About this study
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.
- Conditions
- Retinal Vascular Occlusion
- Being tested
- Watchpat 100
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Watchpat 100Device
Also called Watch-PAT™ 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Watchpat-100(noninvasive portable sleep monitoring device)
Result Data of Watchpat-100 : apnea-hypopnea index(AHI)
Measured: after finishing the tests with Watchpat-100
Berlin questionnaire
Incidence of patients at risk for obstructive sleep apnea according to the Berlin questionnaire
Measured: after finishing the Berlin questionnaire
Epworth sleepiness scale
Incidence of patients with daytime sleepiness according to the Epworth sleepiness scale.
Measured: after finishing the Epworth sleepiness sclae
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2011 (estimated)
- Study startJun 2010
- Primary completionJun 2012 (estimated)
- Study completionJun 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Retinal Vascular OcclusionStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01291862
- Sponsor's protocol ID
- 1-2010-0008
- Status last verified
- Jan 2012
- First submitted
- 1 Feb 2011
- Last updated
- 2 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27051260
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obstructive Sleep Apnea, Retinal Vein Occlusion, Retinal Artery Occlusion
- ClinicalTrials.gov ID
- NCT01291862
- Acronym / sponsor ID
- 1-2010-0008
- Conditions
- Retinal Vascular Occlusion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Jun 2012 (estimated)
- Study completion
- Jun 2012 (estimated)
- First posted
- 9 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Any patient who visits outpatient clinic and diagnosed as retinal vascular occlusion which occurred within recent 3 months
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Watchpat 100Also: Watch-PAT™ 100Watchpat 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. | Device | – |
Primary outcome
Watchpat-100(noninvasive portable sleep monitoring device)
Time frame: after finishing the tests with Watchpat-100
Result Data of Watchpat-100 : apnea-hypopnea index(AHI)
Berlin questionnaire
Time frame: after finishing the Berlin questionnaire
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
Incidence of patients with daytime sleepiness according to the Epworth sleepiness scale.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2012.
- Derived from this study: PubMed 27051260Kwon 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.
Related trials for Retinal Vascular Occlusion
Active, not recruitingObservational study
Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)
Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
Not yet recruitingObservational study
The GEIR (Grupo español de Ictus Retina) Registry: Rationale and Design of the First Nationwide Multicentre Retinal Stroke Registry in Spain
Retinal Artery Occlusion, Central Retinal Artery Occlusion
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Not yet recruitingObservational study
A Case-Control Study Revealing Intraocular Microenvironment Characteristics in Patients With Ocular Diseases Based on Multi-Omics Analysis
Age- Related Macular Degeneration, Diabetic Retinopathy
RecruitingObservational study
National Eye Institute Biorepository for Retinal Diseases
Age-Related Macular Degeneration, Diabetic Retinopathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Watchpat 100 in people with Retinal Vascular Occlusion, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Watchpat-100(noninvasive portable sleep monitoring device) (time frame: after finishing the tests with Watchpat-100). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01291862, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2012.