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NCT04011358 Clinical Trial

Retinal Vein Occlusion and Obstructive Sleep Apnea: A Case Control Study

Obstructive Sleep Apnea Clinical Trial

— SASOVR  

Official title:
Retinal Vein Occlusion and Obstructive Sleep Apnea: A Case Control Study

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT04011358
Other study ID # CHRO-2018-14
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date September 2021
Est. completion date September 2022

Study information
Verified date October 2021
Source Centre Hospitalier Régional d'Orléans
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study purpose is to evaluate the association between Retinal Vein Occlusion and Obstructive Sleep Apnea.

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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date September 2022
Est. primary completion date September 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Sleeping Monitor
to evaluate obstructive sleep apnea

Locations
Country Name City State
France CHR d'Orléans Orléans

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Régional d'Orléans

Country where clinical trial is conducted

France, 

References & Publications (4)

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. — View 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 20 — View 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. — View 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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Apnea Hypopnea index >5/hour Obstructive Sleepin Apnea diagnostic depends only on the AHI which is measured by the Sleeping Monitor at home. Hour 12
Secondary 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		 Hour 12
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