Retinal Vein OcclusionSASOVRNCT04011358
Retinal Vein Occlusion and Obstructive Sleep Apnea: A Case Control Study
A study testing Sleeping Monitor in people with Retinal Vein Occlusion and Obstructive Sleep Apnea, run by Centre Hospitalier Régional d'Orléans at 1 site in France.
Trial summary
This study purpose is to evaluate the association between Retinal Vein Occlusion and Obstructive Sleep Apnea. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Retinal Vein Occlusion, Obstructive Sleep Apnea
- What is being tested?
- Sleeping Monitor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2021to Sep 2022
- Phase
- Interventional
- 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
Who may be able to join
- 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
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- Chronic opioid medication
- Pregnancy women.
- Patient under guardianship
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
This study purpose is to evaluate the association between Retinal Vein Occlusion and Obstructive Sleep Apnea.
Read the 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.
- Conditions
- Retinal Vein Occlusion, Obstructive Sleep Apnea
- Being tested
- Sleeping Monitor
- Keywords
- Retinal Vein Occlusion, central retinal vein occlusion, branch retinal vein occlusion, obstructive sleep apnea, sleep apnea
- Medical subject headings
- Retinal Vein Occlusion, Sleep Apnea, Obstructive, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleeping MonitorOther
to evaluate obstructive sleep apnea
| Study group | Role | What they receive |
|---|---|---|
| Patient | Other | Patient with Retinal Vein Occlusion Receives: Other: Sleeping Monitor |
| Patient control | Other | Patient with no Retinal Vein Occlusion Receives: Other: Sleeping Monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea Hypopnea index >5/hour
Obstructive Sleepin Apnea diagnostic depends only on the AHI which is measured by the Sleeping Monitor at home.
Measured: Hour 12
Secondary outcomes (1)
Berlin Questionnaire sleep test
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
Measured: Hour 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2019
- Study startSep 2021 (estimated)
- Primary completionSep 2022 (estimated)
- Study completionSep 2022 (estimated)
Why it stopped: Given the health context and the work overload, this study will not be possible. We therefore abandon this project
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Retinal Vein OcclusionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- case-control comparison study
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional d'Orléans
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre BONICEL, Dr, Principal investigator, CHR Orléans
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04011358
- Sponsor's protocol ID
- CHRO-2018-14
- Acronym
- SASOVR
- Status last verified
- Oct 2021
- First submitted
- 7 Jun 2019
- Last updated
- 27 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 21149775Chou 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.
PubMed 22464364Kwon 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.
PubMed 27051260Agard 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.
PubMed 30188014
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retinal Vein Occlusion and Obstructive Sleep Apnea: A Case Control Study
- ClinicalTrials.gov ID
- NCT04011358
- Acronym / sponsor ID
- SASOVR / CHRO-2018-14
- Conditions
- Retinal Vein Occlusion, Obstructive Sleep Apnea
- Keywords
- Retinal Vein Occlusion, central retinal vein occlusion, branch retinal vein occlusion, obstructive sleep apnea, sleep apnea
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Given the health context and the work overload, this study will not be possible. We therefore abandon this project
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional d'OrléansUniversity, hospital or other
- Study start
- Sep 2021 (estimated)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 8 Jul 2019 (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 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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- case-control comparison study
| Arm | Type | Receives |
|---|---|---|
| Patient | Other | Other: Sleeping MonitorPatient with Retinal Vein Occlusion |
| Patient control | Other | Other: Sleeping MonitorPatient with no Retinal Vein Occlusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- All patients with an Retinal Vein Occlusion for one group (patients)
- All patients with no Retinal Vein Occlusion for the other group (control)
- minor
- Severe Insomnia
- Neuromuscular Disease with respiratory muscle impairment
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleeping Monitorto evaluate obstructive sleep apnea | Other | Patient, Patient control |
Primary outcome
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.
1 secondary outcome
Berlin Questionnaire sleep test
Time frame: Hour 12
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2021.
- Results publication: PubMed 21149775Glacet-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.
- Results publication: PubMed 22464364Chou 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.
- Results publication: PubMed 27051260Kwon 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.
- Results publication: PubMed 30188014Agard 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.
- Individual participant dataSharing planned: No
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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.
Pierre BONICEL, Dr principal investigator
CHR Orléans
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleeping Monitor in people with Retinal Vein Occlusion and Obstructive Sleep Apnea, run by Centre Hospitalier Régional d'Orléans 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 9 inclusion and 0 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: withdrawn, as of the sponsor's last update on 27 Oct 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apnea Hypopnea index >5/hour (time frame: Hour 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04011358, which also lists 4 linked publications.
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 27 Oct 2021.