ChorioretinopathyCRSANCT04634786
Association Between CRSA and OSA
An observational study of Chorioretinopathy and Obstructive Sleep Apnea, run by Poitiers University Hospital at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chorioretinopathy, Obstructive Sleep Apnea
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- 6 Feb 2021to 6 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Central serous chorioretinopathy since 6 months at least
- Patients beyond 18 years old
Who cannot join
- All retina pathology will be excluded : diabetes with affected retina, maculopathy, retina central veinous oclusion, epithéliopathy
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU de Poitiers
Poitiers
Nicolas LEVEZIEL, Pr
About this study
Official title: The Association Between Central Serous Chorioretinopathy and the Obstructive Sleep Apnea
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.
- Conditions
- Chorioretinopathy, Obstructive Sleep Apnea
- Medical subject headings
- Sleep Apnea, Obstructive
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During 3 months we will collect the results of Berlin survey.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2020
- Study start6 Feb 2021
- Primary completion6 Aug 2021 (estimated)
- Study completion6 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ChorioretinopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04634786
- Sponsor's protocol ID
- 2020-A02305-34
- Acronym
- CRSA
- Status last verified
- Apr 2021
- First submitted
- 12 Nov 2020
- Last updated
- 19 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association Between Central Serous Chorioretinopathy and the Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT04634786
- Acronym / sponsor ID
- CRSA / 2020-A02305-34
- Conditions
- Chorioretinopathy, Obstructive Sleep Apnea
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 6 Feb 2021 (actual)
- Primary completion
- 6 Aug 2021 (estimated)
- Study completion
- 6 Aug 2021 (estimated)
- First posted
- 18 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Central serous chorioretinopathy since 6 months at least
- Patients beyond 18 years old
Key exclusion criteria (1 listed)
- All retina pathology will be excluded : diabetes with affected retina, maculopathy, retina central veinous oclusion, epithéliopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Association between central serous chorioretinopathy and the obstructive sleep apnea.
Time frame: During 3 months we will collect the results of Berlin survey.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chorioretinopathy and Obstructive Sleep Apnea, run by Poitiers University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nicolas LEVEZIEL, Pr (0549444182 ext. +33, nicolas.leveziel@chu-poitiers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association between central serous chorioretinopathy and the obstructive sleep apnea. (time frame: During 3 months we will collect the results of Berlin survey.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2021.