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

• Sponsor: Centre Hospitalier Régional d'Orléans (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT04011358
• Collaborator: (none)
• Enrollment: 0
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 12
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Retinal Vein Occlusion; Obstructive Sleep Apnea	Other: Sleeping Monitor	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: case-control comparison studycase-control comparison study
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Retinal Vein Occlusion and Obstructive Sleep Apnea: A Case Control Study
• Anticipated Study Start Date: Sep 1, 2021
• Anticipated Primary Completion Date: Sep 1, 2022
• Anticipated Study Completion Date: Sep 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHR d'Orléans	Orléans		France	45067

Sponsors and Collaborators

• Centre Hospitalier Régional d'Orléans

Investigators

• Principal Investigator: Pierre BONICEL, Dr, CHR Orléans

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Hospitalier Régional d'Orléans
• ClinicalTrials.gov Identifier: NCT04011358
• Other Study ID Numbers: CHRO-2018-14
• First Posted: Jul 8, 2019
• Last Update Posted: Oct 27, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Centre Hospitalier Régional d'Orléans: Retinal Vein Occlusion; central retinal vein occlusion; branch retinal vein occlusion; obstructive sleep apnea; sleep apnea
• Additional relevant MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Retinal Vein Occlusion

Study Results

No Results Posted as of Oct 27, 2021