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Trial record 1 of 1 for:    19639754 [PUBMED-IDS]
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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

Tracking Information
First Submitted Date April 14, 2019
First Posted Date April 26, 2019
Last Update Posted Date April 26, 2019
Actual Study Start Date October 1, 2012
Estimated Primary Completion Date October 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 24, 2019)
  • 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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: April 24, 2019)
  • 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.
  • 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).
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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)
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: April 24, 2019)
  • 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)
  • 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%).
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title 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
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 Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration 10 Years
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Adult individuals with an indication for therapy with positive airway pressure.
Condition
  • Sleep Apnea
  • Glaucoma
  • Ocular Hypertension
Intervention Not Provided
Study Groups/Cohorts
  • Control group
  • Sleep apnea using CEPAP
  • Sleep apnea not using CEPAP
  • Glaucoma control group
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 24, 2019)
150
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 1, 2027
Estimated Primary Completion Date October 1, 2022   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: Joanna Przeździecka-Dołyk, PhD 71 736 43 00 ext +48 klo@uszk.wroc.pl
Listed Location Countries Poland
Removed Location Countries  
 
Administrative Information
NCT Number NCT03928665
Other Study ID Numbers ST.2012.001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Joanna Przeździecka-Dołyk, Wroclaw Medical University
Study Sponsor Wroclaw Medical University
Collaborators Wrocław University of Science and Technology
Investigators
Study Chair: Marta Misiuk-Hojło, Professor Wrocław Medical University
PRS Account Wroclaw Medical University
Verification Date April 2019