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

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ClinicalTrials.gov Identifier: NCT03928665
Recruitment Status : Recruiting
First Posted : April 26, 2019
Last Update Posted : April 26, 2019
Sponsor:
Collaborator:
Wrocław University of Science and Technology
Information provided by (Responsible Party):
Joanna Przeździecka-Dołyk, 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.

Condition or disease
Sleep Apnea Glaucoma Ocular Hypertension

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 150 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: Long-term Observation of Ophthalmic Changes in Patients With Obstructive Sleep Apnea
Actual Study Start Date : October 1, 2012
Estimated Primary Completion Date : October 1, 2022
Estimated Study Completion Date : October 1, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

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



Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. Functional Outcomes of Sleep Questionnaire [ Time Frame: 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.

  2. Epworth Sleepiness Scale [ Time Frame: 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).

  3. Pittsburgh Sleep Quality Index [ Time Frame: 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.

  4. Change in thickness of the retinal nerve fibre layer (RNFL) [ Time Frame: 10 years ]
    A difference in thickness of the retinal nerve fibre layer during the observation time frame.

  5. Change in the optic nerve morphology - standard chart of HRT [ Time Frame: 10 years ]
    A difference in morphology parameters given by HRT (additional information given in supplementary materials) during the observation time frame.

  6. AREDS 2008 Clinical Lens Opacity Grading Procedure [ Time Frame: 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.

  7. Macular changes in optical coherent tomography (OCT) [ Time Frame: 10 years ]
    Evaluation of macular appearance based on the OCT scans. Any changes from normal appearance will be recorded and evaluated.

  8. Disc damage likelihood scale (DDLS) [ Time Frame: 10 years ]
    Evaluation disc damage likelihood scale based on the fundus photographs (based on the visual scale given in additional documents)


Other Outcome Measures:
  1. Influence of fogging lens on retinal sensitivity to given trigger (Goldman III) on standard automated and RareBit perimetry [ Time Frame: 1 day ]
    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)

  2. Influence of tiredness on retinal sensitivity to given trigger (Goldman III) on standard automated and RareBit perimetry [ Time Frame: 1 day ]
    Influence of different examinations that precedes visual field examination on the perimetry test results (MD and PSD, or MHR, MMR and area under 90%).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Adult individuals with an indication for therapy with positive airway pressure.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03928665


Contacts
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Contact: Joanna Przeździecka-Dołyk, PhD 71 736 43 00 ext +48 klo@uszk.wroc.pl

Locations
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Poland
Department of Ophthalmology Recruiting
Wrocław, Poland, 50-556
Contact: Joanna Przeździecka-Dołyk, PhD         
Principal Investigator: Ziemowit Poznański, M.D.         
Sponsors and Collaborators
Wroclaw Medical University
Wrocław University of Science and Technology
Investigators
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Study Chair: Marta Misiuk-Hojło, Professor Wrocław Medical University

Study Data/Documents: DDLS - reference  This link exits the ClinicalTrials.gov site

Publications:
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Responsible Party: Joanna Przeździecka-Dołyk, Investigator, Wroclaw Medical University
ClinicalTrials.gov Identifier: NCT03928665     History of Changes
Other Study ID Numbers: ST.2012.001
First Posted: April 26, 2019    Key Record Dates
Last Update Posted: April 26, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Ocular Hypertension
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Eye Diseases