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

Not Applicable

Withdrawn

• Conditions: Retinal Vein Occlusion; Obstructive Sleep Apnea
• Interventions: Other: Sleeping Monitor

• Registration Number: NCT04011358
• Lead Sponsor: Centre Hospitalier Régional d'Orléans

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.

Study Timeline

• Study First Submitted: 2019-06-07
• Study First Submitted QC: 2019-07-04
• Study First Posted: 2019-07-08
• Study Start: 2021-09
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-20
• Last Update Posted: 2021-10-27
• Primary Completion: 2022-09
• Study Completion: 2022-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patient control	Sleeping Monitor	Patient with no Retinal Vein Occlusion
Patient	Sleeping Monitor	Patient with Retinal Vein Occlusion

Primary Outcome Measures

Name	Time	Method
Apnea Hypopnea index >5/hour	Hour 12	Obstructive Sleepin Apnea diagnostic depends only on the AHI which is measured by the Sleeping Monitor at home.

Secondary Outcome Measures

Name	Time	Method
Berlin Questionnaire sleep test	Hour 12	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

Trial Locations

Locations (1)

CHR d'Orléans; 🇫🇷 Orléans, France