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

October 20, 2021 updated by: Centre Hospitalier Régional d'Orléans
This study purpose is to evaluate the association between Retinal Vein Occlusion and Obstructive Sleep Apnea.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Orléans, France, 45067
        • CHR d'Orléans

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Patient
Patient with Retinal Vein Occlusion
Other: Sleeping Monitor
to evaluate obstructive sleep apnea
OTHER: Patient control
Patient with no Retinal Vein Occlusion
Other: Sleeping Monitor
to evaluate obstructive sleep apnea

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Apnea Hypopnea index >5/hour
Time Frame: Hour 12
Obstructive Sleepin Apnea diagnostic depends only on the AHI which is measured by the Sleeping Monitor at home.
Hour 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Berlin Questionnaire sleep test
Time Frame: 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
Hour 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Régional d'Orléans

Investigators

  • Principal Investigator: Pierre BONICEL, Dr, CHR Orléans

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

September 1, 2021

Primary Completion (ANTICIPATED)

September 1, 2022

Study Completion (ANTICIPATED)

September 1, 2022

Study Registration Dates

First Submitted

June 7, 2019

First Submitted That Met QC Criteria

July 4, 2019

First Posted (ACTUAL)

July 8, 2019

Study Record Updates

Last Update Posted (ACTUAL)

October 27, 2021

Last Update Submitted That Met QC Criteria

October 20, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHRO-2018-14

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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