Retinal Vein Occlusion and Obstructive Sleep Apnea: A Case Control Study (SASOVR)
Primary Purpose
Retinal Vein Occlusion, Obstructive Sleep Apnea
Status
Withdrawn
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Sleeping Monitor
Sponsored by
About this trial
This is an interventional prevention trial for Retinal Vein Occlusion focused on measuring Retinal Vein Occlusion, central retinal vein occlusion, branch retinal vein occlusion, obstructive sleep apnea, sleep apnea
Eligibility Criteria
Inclusion Criteria:
- All patients with an Retinal Vein Occlusion for one group (patients)
- All patients with no Retinal Vein Occlusion for the other group (control)
Non-inclusion Criteria:
- minor
- Severe Insomnia
- Neuromuscular Disease with respiratory muscle impairment
- Chronic opioid medication
- Pregnancy women.
- Patient under guardianship
Sites / Locations
- CHR d'Orléans
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Patient
Patient control
Arm Description
Patient with Retinal Vein Occlusion
Patient with no Retinal Vein Occlusion
Outcomes
Primary Outcome Measures
Apnea Hypopnea index >5/hour
Obstructive Sleepin Apnea diagnostic depends only on the AHI which is measured by the Sleeping Monitor at home.
Secondary Outcome Measures
Berlin Questionnaire sleep test
High Risk of Sleep Apnea Syndrome:
If there are 2 or more Categories where the score is 2 or above
Low Risk of Sleep Apnea Syndrome:
If there is only 1 or no Categories where the score is 2 or above
Full Information
NCT ID
NCT04011358
First Posted
June 7, 2019
Last Updated
October 20, 2021
Sponsor
Centre Hospitalier Régional d'Orléans
1. Study Identification
Unique Protocol Identification Number
NCT04011358
Brief Title
Retinal Vein Occlusion and Obstructive Sleep Apnea: A Case Control Study
Acronym
SASOVR
Official Title
Retinal Vein Occlusion and Obstructive Sleep Apnea: A Case Control Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Given the health context and the work overload, this study will not be possible. We therefore abandon this project
Study Start Date
September 2021 (Anticipated)
Primary Completion Date
September 2022 (Anticipated)
Study Completion Date
September 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Régional d'Orléans
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study purpose is to evaluate the association between Retinal Vein Occlusion and Obstructive Sleep Apnea.
Detailed Description
There will be two groups of 50 patients. One with Retinal Vein Occlusion, and the other one, with no Retinal Vein Occlusion will be chosen from the consultation.
The compared group will be paired on different criteria including hypertension, ocular hypertension, diabetes, sex, age.
They will all spend a night at home with a Sleeping Monitor (Nox T3) in order to evaluate if they have an Obstructive Sleep Apnea.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinal Vein Occlusion, Obstructive Sleep Apnea
Keywords
Retinal Vein Occlusion, central retinal vein occlusion, branch retinal vein occlusion, obstructive sleep apnea, sleep apnea
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
case-control comparison study
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patient
Arm Type
Other
Arm Description
Patient with Retinal Vein Occlusion
Arm Title
Patient control
Arm Type
Other
Arm Description
Patient with no Retinal Vein Occlusion
Intervention Type
Other
Intervention Name(s)
Sleeping Monitor
Intervention Description
to evaluate obstructive sleep apnea
Primary Outcome Measure Information:
Title
Apnea Hypopnea index >5/hour
Description
Obstructive Sleepin Apnea diagnostic depends only on the AHI which is measured by the Sleeping Monitor at home.
Time Frame
Hour 12
Secondary Outcome Measure Information:
Title
Berlin Questionnaire sleep test
Description
High Risk of Sleep Apnea Syndrome:
If there are 2 or more Categories where the score is 2 or above
Low Risk of Sleep Apnea Syndrome:
If there is only 1 or no Categories where the score is 2 or above
Time Frame
Hour 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All patients with an Retinal Vein Occlusion for one group (patients)
All patients with no Retinal Vein Occlusion for the other group (control)
Non-inclusion Criteria:
minor
Severe Insomnia
Neuromuscular Disease with respiratory muscle impairment
Chronic opioid medication
Pregnancy women.
Patient under guardianship
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre BONICEL, Dr
Organizational Affiliation
CHR Orléans
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHR d'Orléans
City
Orléans
ZIP/Postal Code
45067
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
21149775
Citation
Glacet-Bernard A, Leroux les Jardins G, Lasry S, Coscas G, Soubrane G, Souied E, Housset B. Obstructive sleep apnea among patients with retinal vein occlusion. Arch Ophthalmol. 2010 Dec;128(12):1533-8. doi: 10.1001/archophthalmol.2010.272.
Results Reference
result
PubMed Identifier
22464364
Citation
Chou KT, Huang CC, Tsai DC, Chen YM, Perng DW, Shiao GM, Lee YC, Leu HB. Sleep apnea and risk of retinal vein occlusion: a nationwide population-based study of Taiwanese. Am J Ophthalmol. 2012 Jul;154(1):200-205.e1. doi: 10.1016/j.ajo.2012.01.011. Epub 2012 Mar 30.
Results Reference
result
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
result
PubMed Identifier
30188014
Citation
Agard E, El Chehab H, Vie AL, Voirin N, Coste O, Dot C. Retinal vein occlusion and obstructive sleep apnea: a series of 114 patients. Acta Ophthalmol. 2018 Dec;96(8):e919-e925. doi: 10.1111/aos.13798. Epub 2018 Sep 6.
Results Reference
result
Learn more about this trial
Retinal Vein Occlusion and Obstructive Sleep Apnea: A Case Control Study
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