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

Active, not recruiting

• Conditions: Sleep Apnea; Glaucoma; Ocular Hypertension

• Registration Number: NCT03928665
• Lead Sponsor: Wroclaw Medical University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10-01
• Study First Submitted: 2019-04-14
• Study First Submitted QC: 2019-04-24
• Study First Posted: 2019-04-26
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-03
• Last Update Posted: 2022-11-04
• Primary Completion: 2022-12-01
• Study Completion: 2027-10-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Perimetry changes over the years	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	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	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.

Secondary Outcome Measures

Name	Time	Method
Epworth Sleepiness Scale	10 years	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).
Pittsburgh Sleep Quality Index	10 years	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.
Macular changes in optical coherent tomography (OCT)	10 years	Evaluation of macular appearance based on the OCT scans. Any changes from normal appearance will be recorded and evaluated.
Disc damage likelihood scale (DDLS)	10 years	Evaluation disc damage likelihood scale based on the fundus photographs (based on the visual scale given in additional documents)
Functional Outcomes of Sleep Questionnaire	10 years	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.
Change in thickness of the retinal nerve fibre layer (RNFL)	10 years	A difference in thickness of the retinal nerve fibre layer during the observation time frame.
Change in the optic nerve morphology - standard chart of HRT	10 years	A difference in morphology parameters given by HRT (additional information given in supplementary materials) during the observation time frame.
AREDS 2008 Clinical Lens Opacity Grading Procedure	10 years	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.

Trial Locations

Locations (1)

Department of Ophthalmology; 🇵🇱 Wrocław, Poland