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出境医 / 临床实验 / Retinal Vein Occlusion and Obstructive Sleep Apnea: A Case Control Study (SASOVR)

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

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 Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: case-control comparison study
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Retinal Vein Occlusion and Obstructive Sleep Apnea: A Case Control Study
Estimated Study Start Date : May 2021
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : May 2022
Arms and Interventions
Arm Intervention/treatment
Patient
Patient with Retinal Vein Occlusion
 Other: Sleeping Monitor
to evaluate obstructive sleep apnea
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 [ Time Frame: 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 [ 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



Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Contacts
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Contact: Aurélie DESPUJOS 02.38.74.40.71 aurelie.despujols@chr-orleans.fr

Locations
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France
CHR d'Orléans
Orléans, France, 45067
Contact: Aurélie DESPUJOLS    02.38.74.40.71    aurelie.despujols@chr-orléans.fr   
Principal Investigator: Pierre BONICEL, Dr         
Sponsors and Collaborators
Centre Hospitalier Régional d'Orléans
Investigators
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Principal Investigator: Pierre BONICEL, Dr CHR Orléans
Tracking Information
First Submitted Date  ICMJE June 7, 2019
First Posted Date  ICMJE July 8, 2019
Last Update Posted Date February 11, 2021
Estimated Study Start Date  ICMJE May 2021
Estimated Primary Completion Date May 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 4, 2019) 		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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 4, 2019) 		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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Retinal Vein Occlusion and Obstructive Sleep Apnea: A Case Control Study
Official Title  ICMJE Retinal Vein Occlusion and Obstructive Sleep Apnea: A Case Control Study
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
case-control comparison study
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Retinal Vein Occlusion
  • Obstructive Sleep Apnea
Intervention  ICMJE Other: Sleeping Monitor
to evaluate obstructive sleep apnea
Study Arms  ICMJE
  • Patient
    Patient with Retinal Vein Occlusion
    Intervention: Other: Sleeping Monitor
  • Patient control
    Patient with no Retinal Vein Occlusion
    Intervention: Other: Sleeping Monitor
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.
  • 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.
  • 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.
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: July 4, 2019) 		100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2022
Estimated Primary Completion Date May 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Aurélie DESPUJOS 02.38.74.40.71 aurelie.despujols@chr-orleans.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04011358
Other Study ID Numbers  ICMJE CHRO-2018-14
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Centre Hospitalier Régional d'Orléans
Study Sponsor  ICMJE Centre Hospitalier Régional d'Orléans
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Pierre BONICEL, Dr CHR Orléans
PRS Account Centre Hospitalier Régional d'Orléans
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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