NCT04634786

Brief Summary

This goal of this study is to know the association between the central serous chorioretinopathy and the obstructive sleep apnea. Many studies have been done in order to assess the association between the central serous chorioretinopathy and obstructive sleep apnea and the results are always controverses actually.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 12, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 18, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

February 6, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 6, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 6, 2021

Completed
Last Updated

April 19, 2021

Status Verified

April 1, 2021

Enrollment Period

6 months

First QC Date

November 12, 2020

Last Update Submit

April 13, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Association between central serous chorioretinopathy and the obstructive sleep apnea.

    Percentage of high risks of obstructive sleep apnea in patients affected by central serous chorioretinopathy in using the Berlin survey. The Berlin questions include 3 categories: The category 1 is positive if 2 answers are positive. The category 2 is positive if 2 answers are positive. The category 3 is positive if 1 answer is positive. Finally, if 2 categories are positive, the patient is considered as high risk of obstructive sleep apnea.

    During 3 months we will collect the results of Berlin survey.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The central serous chorioretinopathy is defined by RSD (retinal serous detachment) located to the macula, it must be diagnosed since 6 months. Patients with central serous chorioretinopathy will undergo a Berlin Questions to assess the risks to have an obstructive sleep apnea. More over, we measure the choroid's thickness by using EDI OCT(Enhanced depth imaging optical coherence tomography) The survey and the measure of the choroid's thickness will be performed during an ophthalmology routing consultation.

You may qualify if:

  • Central serous chorioretinopathy since 6 months at least
  • Patients beyond 18 years old

You may not qualify if:

  • \- All retina pathology will be excluded : diabetes with affected retina, maculopathy, retina central veinous oclusion, epithéliopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Poitiers

Poitiers, France

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 12, 2020

First Posted

November 18, 2020

Study Start

February 6, 2021

Primary Completion

August 6, 2021

Study Completion

August 6, 2021

Last Updated

April 19, 2021

Record last verified: 2021-04

Locations