Sleep ApneaNCT03928665
Long-term Observation of Ophthalmic Changes in Patients With Obstructive Sleep Apnea
An observational study of Sleep Apnea and Glaucoma, run by Wroclaw Medical University at 1 site in Poland.
Trial summary
The ophthalmic changes during long-lasting sleep apnea are lacking in description and assessment. The investigators intend to observe patients for a long time and observe if the changes in eye tissues are progressing over the years in easily recognizable patterns. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Apnea, Glaucoma, Ocular Hypertension
- How many people
- 150 participants
- Where
- 1 sitePoland
- Study dates
- 1 Oct 2012to 1 Oct 2027
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Adult, Older adult
Study population: Adult individuals with an indication for therapy with positive airway pressure.
Who may be able to join
- newly diagnosed obstructive sleep apnea indicated for positive airway pressure therapy,
- ongoing treatment of sleep apnea with positive airway pressure therapy,
- patients older than 18 years,
- signed inform consent
Who cannot join
- pregnant and breastfeeding persons
Trial locations and contacts
1 site in 1 country.
About this study
The ophthalmic changes during long-lasting sleep apnea are lacking in description and assessment. The investigators intend to observe patients for a long time and observe if the changes in eye tissues are progressing over the years in easily recognizable patterns.
- Conditions
- Sleep Apnea, Glaucoma, Ocular Hypertension
- Medical subject headings
- Sleep Apnea Syndromes, Glaucoma, Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Not described | |
| Sleep apnea using CEPAP | Not described | |
| Sleep apnea not using CEPAP | Not described | |
| Glaucoma control group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perimetry changes over the years
Changes in retinal sensitivity (measured in decibels/ dB) during observation time measured by standard automated perimetry. The manner of presentation of overall descriptors auch as: mean deviation (MD; dB) and pattern standard deviation (PSD; dB) will be recorded.
Measured: 10 years
Flicker defined form perimetry changes over the years
Changes in retinal sensitivity (measured in decibels/ dB) during observation time measured by standard automated perimetry with flicker defined form signal. The manner of presentation of overall descriptors auch as: mean deviation (MD; dB) and pattern standard deviation (PSD; dB) will be recorded.
Measured: 10 years
RareBit perimetry changes over the years
Changes in Changes in retinal sensitivity (measured in percentage of all presented excitors/ %) during observation time measured by RareBit signal perimetry. The manner of presentation of overall descriptors auch as: mean hit rate (MHR; %), area under 90% (%) and sectorial mean miss rate (MMR; %) will be recorded.
Measured: 10 years
Secondary outcomes (8)
Functional Outcomes of Sleep Questionnaire
Quality assessed with the Functional Outcomes of Sleep Questionnaire (FOSQ) comparing the score at baseline with during 10 years of observation. The questionnaire are composed of 30 questions that can be answered from 1 to 4 points (where 1 means extreme difficulty of doing an activity and 4 - no difficulties). Five subscales are given such as: General Productivity (8 questions -1 - 4, 8 - 11), Social Outcome (2 questions - 12, 13), Activity Level (9 questions - 5, 14 - 16, 22 - 26), Vigilance (7 questions - 6, 7, 17 - 21), Intimate Relationships and Sexual Activity (4 questions - 27 - 30). To obtain a Total Score: Calculate the mean of the subscale scores and multiply that mean by the number of subscales for which there is a score. The potential range of scores for the Total Score is 5 - 20.
Measured: 10 years
Epworth Sleepiness Scale
Quality assessed with the Epworth Sleepiness Scale comparing the score at baseline with during 10 years of observation. The questionnaire are composed of 8 questions describing activities during which patient can feel sleepy, each scored from 0 (zero probability to falling asleep) to 3 (very likely that patient will fall asleep).
Measured: 10 years
Pittsburgh Sleep Quality Index
Quality assessed with the Pittsburgh Sleep Quality Index comparing the score at baseline with during 10 years of observation. The questionnaire are composed of 10 questions composed in seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.
Measured: 10 years
Change in thickness of the retinal nerve fibre layer (RNFL)
A difference in thickness of the retinal nerve fibre layer during the observation time frame.
Measured: 10 years
Change in the optic nerve morphology - standard chart of HRT
A difference in morphology parameters given by HRT (additional information given in supplementary materials) during the observation time frame.
Measured: 10 years
AREDS 2008 Clinical Lens Opacity Grading Procedure
Using AREDS system for classifying cataracts from photographs: AREDS Report No. 4 the lens opacity will be graded. The change in grading during the observation time frame.
Measured: 10 years
Macular changes in optical coherent tomography (OCT)
Evaluation of macular appearance based on the OCT scans. Any changes from normal appearance will be recorded and evaluated.
Measured: 10 years
Disc damage likelihood scale (DDLS)
Evaluation disc damage likelihood scale based on the fundus photographs (based on the visual scale given in additional documents)
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2019
- Study start1 Oct 2012
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sleep ApneaStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Wroclaw Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Wrocław University of Science and Technology
- Responsible party
- Principal investigator, Joanna Przeździecka-Dołyk, Wroclaw Medical University
- Investigators
- Marta Misiuk-Hojło, Professor, Study chair, Wroclaw Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03928665
- Sponsor's protocol ID
- ST.2012.001
- Status last verified
- Nov 2022
- First submitted
- 14 Apr 2019
- Last updated
- 4 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chasens ER, Ratcliffe SJ, Weaver TE. Development of the FOSQ-10: a short version of the Functional Outcomes of Sleep Questionnaire. Sleep. 2009 Jul;32(7):915-9. doi: 10.1093/sleep/32.7.915.
PubMed 19639754Oddone F, Centofanti M, Rossetti L, Iester M, Fogagnolo P, Capris E, Manni G. Exploring the Heidelberg Retinal Tomograph 3 diagnostic accuracy across disc sizes and glaucoma stages: a multicenter study. Ophthalmology. 2008 Aug;115(8):1358-65, 1365.e1-3. doi: 10.1016/j.ophtha.2008.01.007. Epub 2008 Mar 5.
PubMed 18321579
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Observation of Ophthalmic Changes in Patients With Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT03928665
- Acronym / sponsor ID
- ST.2012.001
- Conditions
- Sleep Apnea, Glaucoma, Ocular Hypertension
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Wroclaw Medical UniversityUniversity, hospital or other
- Collaborators
- Wrocław University of Science and Technology
- Study start
- 1 Oct 2012 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 26 Apr 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.
The ophthalmic changes during long-lasting sleep apnea are lacking in description and assessment. The investigators intend to observe patients for a long time and observe if the changes in eye tissues are progressing over the years in easily recognizable patterns.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control group | – | – |
| Sleep apnea using CEPAP | – | – |
| Sleep apnea not using CEPAP | – | – |
| Glaucoma control group | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult individuals with an indication for therapy with positive airway pressure.
Key inclusion criteria (4 listed)
- newly diagnosed obstructive sleep apnea indicated for positive airway pressure therapy,
- ongoing treatment of sleep apnea with positive airway pressure therapy,
- patients older than 18 years,
- signed inform consent
Key exclusion criteria (1 listed)
- pregnant and breastfeeding persons
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
Perimetry changes over the years
Time frame: 10 years
Changes in retinal sensitivity (measured in decibels/ dB) during observation time measured by standard automated perimetry. The manner of presentation of overall descriptors auch as: mean deviation (MD; dB) and pattern standard deviation (PSD; dB) will be recorded.
Flicker defined form perimetry changes over the years
Time frame: 10 years
Changes in retinal sensitivity (measured in decibels/ dB) during observation time measured by standard automated perimetry with flicker defined form signal. The manner of presentation of overall descriptors auch as: mean deviation (MD; dB) and pattern standard deviation (PSD; dB) will be recorded.
RareBit perimetry changes over the years
Time frame: 10 years
Changes in Changes in retinal sensitivity (measured in percentage of all presented excitors/ %) during observation time measured by RareBit signal perimetry. The manner of presentation of overall descriptors auch as: mean hit rate (MHR; %), area under 90% (%) and sectorial mean miss rate (MMR; %) will be recorded.
8 secondary outcomes
Functional Outcomes of Sleep Questionnaire
Time frame: 10 years
Epworth Sleepiness Scale
Time frame: 10 years
Pittsburgh Sleep Quality Index
Time frame: 10 years
Change in thickness of the retinal nerve fibre layer (RNFL)
Time frame: 10 years
Change in the optic nerve morphology - standard chart of HRT
Time frame: 10 years
AREDS 2008 Clinical Lens Opacity Grading Procedure
Time frame: 10 years
Macular changes in optical coherent tomography (OCT)
Time frame: 10 years
Disc damage likelihood scale (DDLS)
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2022.
- Background: PubMed 19639754Chasens ER, Ratcliffe SJ, Weaver TE. Development of the FOSQ-10: a short version of the Functional Outcomes of Sleep Questionnaire. Sleep. 2009 Jul;32(7):915-9. doi: 10.1093/sleep/32.7.915.
- Background: PubMed 18321579Oddone F, Centofanti M, Rossetti L, Iester M, Fogagnolo P, Capris E, Manni G. Exploring the Heidelberg Retinal Tomograph 3 diagnostic accuracy across disc sizes and glaucoma stages: a multicenter study. Ophthalmology. 2008 Aug;115(8):1358-65, 1365.e1-3. doi: 10.1016/j.ophtha.2008.01.007. Epub 2008 Mar 5.
- 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.
Marta Misiuk-Hojło, Professor study chair
Wroclaw Medical University
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 Sleep Apnea and Glaucoma, run by Wroclaw Medical University at 1 site in Poland.
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 4 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: under way, not looking for participants, as of the sponsor's last update on 4 Nov 2022. 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 Poland. 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?
This study is still under way. Results are not available in the source record yet.
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?
Perimetry changes over the years (time frame: 10 years). The study lists 3 primary outcomes in all. 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 NCT03928665, which also lists 2 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 4 Nov 2022; AzTrials last refreshed its copy on 6 Nov 2026.