Long-term Observation of Ophthalmic Changes in Patients With Obstructive Sleep Apnea

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 Overview

• Status: Active, not recruiting
• Conditions: Ocular Hypertension; Glaucoma; Sleep Apnea

• Study Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

Study Locations

• Poland
  • Wrocław, Poland, 50-556
    • Department of Ophthalmology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult individuals with an indication for therapy with positive airway pressure.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
Control group
Sleep apnea using CEPAP
Sleep apnea not using CEPAP
Glaucoma control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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).	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.	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.	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.	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.	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.	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)	10 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peripapillar and macular vessels density	Measured on the custom-derived protocol and manufacturer software macular and peripapillar vessels density - Angio OCT (OCTA)	5 years
Influence of fogging lens on retinal sensitivity to given trigger (Goldman III) on standard automated and RareBit perimetry	A fogging lens will be applied (a modified by the author protocol of fogging - increasing of +0.5D lens to obtain the reduction in logMAR visual acuity by 0.2 from best-corrected visual acuity/ BCVA)	1 day
Influence of tiredness on retinal sensitivity to given trigger (Goldman III) on standard automated and RareBit perimetry	Influence of different examinations that precedes visual field examination on the perimetry test results (MD and PSD, or MHR, MMR and area under 90%).	1 day

Collaborators and Investigators

• Sponsor: Wroclaw Medical University
• Collaborators: Wrocław University of Science and Technology
• Investigators: Study Chair: Marta Misiuk-Hojło, Professor, Wrocław Medical University

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2012
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): October 1, 2027

Study Registration Dates

• First Submitted: April 14, 2019
• First Submitted That Met QC Criteria: April 24, 2019
• First Posted (Actual): April 26, 2019

Study Record Updates

• Last Update Posted (Actual): November 4, 2022
• Last Update Submitted That Met QC Criteria: November 3, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Eye Diseases; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Ocular Hypertension; Apnea
• Other Study ID Numbers: ST.2012.001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Study Data/Documents

1. DDLS - reference

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No