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Clinical Trial Details — Status: Withdrawn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
• Status: Withdrawn
• Phase: N/A
• 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
• 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• Status: Withdrawn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

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Retinal Vein Occlusion
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

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