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WithdrawnNCT04011358SASOVRUpdated Oct 27, 2021

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

An interventional study of Sleeping Monitor in Retinal Vein Occlusion and Obstructive Sleep Apnea, sponsored by Centre Hospitalier Régional d'Orléans. Withdrawn at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-10-27.

Sponsored by Centre Hospitalier Régional d'Orléans · Not applicable, Interventional, and Prevention

Why this study was withdrawn
Given the health context and the work overload, this study will not be possible. We therefore abandon this project
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Retinal Vein Occlusion
  • Obstructive Sleep Apnea

Keywords

  • Retinal Vein Occlusion
  • central retinal vein occlusion
  • branch retinal vein occlusion
  • obstructive sleep apnea
  • sleep apnea
03

In context

Apnea

1,422 studies on the registry are indexed under Apnea; 159 are open to participants now.

Browse Apnea studies →

Lead sponsor

Centre Hospitalier Régional d'Orléans is the lead sponsor of 129 studies on the registry; 31 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Other
    Patient

    Patient with Retinal Vein Occlusion

    Other: Sleeping Monitor

  • Other
    Patient control

    Patient with no Retinal Vein Occlusion

    Other: Sleeping Monitor

Interventions

  • OtherSleeping Monitor

    to evaluate obstructive sleep apnea

06

What researchers measure

Primary outcomes

  1. Apnea Hypopnea index >5/hour

    Obstructive Sleepin Apnea diagnostic depends only on the AHI which is measured by the Sleeping Monitor at home.

    Time frame: Hour 12

Secondary outcomes

  1. 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

    Time frame: Hour 12

07

Study locations

1 site
  • CHR d'Orléans
    Orléans, 45067, France
08

References and documents

Publications

  • 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. PubMed 21149775 ↗
  • 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. PubMed 22464364 ↗
  • 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 ↗
  • 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. PubMed 30188014 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 27, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04011358
Lead sponsor
Centre Hospitalier Régional d'Orléans
Responsible party
Sponsor
First posted
Jul 8, 2019
Start date
Sep 2021 (estimated)
Primary completion
Sep 2022 (estimated)
Completion
Sep 2022 (estimated)
Last update
Oct 27, 2021

Study contacts

Pierre BONICEL, Dr
principal investigator · CHR Orléans

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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