Clinical trial NCT03928665: Long-term Observation of Ophthalmic Changes in Patients With Obstructive Sleep Apnea
Official title: Long-term Observation of Ophthalmic Changes in Patients With Obstructive Sleep Apnea
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Sleep Apnea
Glaucoma
Ocular Hypertension
Lead sponsor: Wroclaw Medical University
Sponsor class: OTHER
Collaborators: name: Wrocław University of Science and Technology
First posted: 2019-04-26
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult individuals with an indication for therapy with positive airway pressure.

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* pregnant and breastfeeding persons

Primary outcomes:
measure: Perimetry changes over the years
timeFrame: 10 years
measure: Flicker defined form perimetry changes over the years
timeFrame: 10 years
measure: RareBit perimetry changes over the years
timeFrame: 10 years
Secondary outcomes:
measure: Functional Outcomes of Sleep Questionnaire
timeFrame: 10 years
measure: Epworth Sleepiness Scale
timeFrame: 10 years
measure: Pittsburgh Sleep Quality Index
timeFrame: 10 years
measure: Change in thickness of the retinal nerve fibre layer (RNFL)
timeFrame: 10 years
measure: Change in the optic nerve morphology - standard chart of HRT
timeFrame: 10 years
measure: AREDS 2008 Clinical Lens Opacity Grading Procedure
timeFrame: 10 years
measure: Macular changes in optical coherent tomography (OCT)
timeFrame: 10 years
measure: Disc damage likelihood scale (DDLS)
timeFrame: 10 years
Other outcomes:
measure: Influence of fogging lens on retinal sensitivity to given trigger (Goldman III) on standard automated and RareBit perimetry
timeFrame: 1 day
measure: Influence of tiredness on retinal sensitivity to given trigger (Goldman III) on standard automated and RareBit perimetry
timeFrame: 1 day
measure: Peripapillar and macular vessels density
timeFrame: 5 years
Locations:
city: Wrocław
country: Poland
facility: Department of Ophthalmology
Study officials:
affiliation: Wrocław Medical University
name: Marta Misiuk-Hojło, Professor
role: STUDY_CHAIR
References:
citation: 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.
citation: Oddone 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.