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

NCT04011358 | Withdrawn

• 1 other identifier: CHRO-2018-14
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Retinal Vein Occlusion; Obstructive Sleep Apnea

Keywords

Retinal Vein Occlusion; central retinal vein occlusion; branch retinal vein occlusion; obstructive sleep apnea; sleep apnea

Outcome Measures

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.

  Hour 12

Secondary Outcomes (1)

• Berlin Questionnaire sleep test

  Hour 12

Study Arms (2)

Patient

OTHER

Patient with Retinal Vein Occlusion

Other: Sleeping Monitor

Patient control

OTHER

Patient with no Retinal Vein Occlusion

Other: Sleeping Monitor

Interventions

Sleeping Monitor OTHER

to evaluate obstructive sleep apnea

Patient; Patient control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients with an Retinal Vein Occlusion for one group (patients)
• All patients with no Retinal Vein Occlusion for the other group (control)
• minor
• Severe Insomnia
• Neuromuscular Disease with respiratory muscle impairment
• Chronic opioid medication
• Pregnancy women.
• Patient under guardianship

Sponsors & Collaborators

• Centre Hospitalier Régional d'Orléans: lead

Study Sites (1)

CHR d'Orléans

Orléans, 45067, France

Location

Related Publications (4)

• 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.

  PMID: 21149775 RESULT

• 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.

  PMID: 22464364 RESULT

• 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.

  PMID: 27051260 RESULT

• 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.

  PMID: 30188014 RESULT

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Pierre BONICEL, Dr

  CHR Orléans

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: case-control comparison study

Study Record Dates

• First Submitted: June 7, 2019
• First Posted: July 8, 2019
• Study Start: September 1, 2021
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: October 27, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)