NCT03928665

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
17mo left

Started Oct 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress91%
Oct 2012Oct 2027

Study Start

First participant enrolled

October 1, 2012

Completed
6.5 years until next milestone

First Submitted

Initial submission to the registry

April 14, 2019

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 26, 2019

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
4.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Expected
Last Updated

November 4, 2022

Status Verified

November 1, 2022

Enrollment Period

10.2 years

First QC Date

April 14, 2019

Last Update Submit

November 3, 2022

Conditions

Sleep ApneaGlaucomaOcular Hypertension

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (8)

  • Functional Outcomes of Sleep Questionnaire

    10 years

  • Epworth Sleepiness Scale

    10 years

  • Pittsburgh Sleep Quality Index

    10 years

  • Change in thickness of the retinal nerve fibre layer (RNFL)

    10 years

  • Change in the optic nerve morphology - standard chart of HRT

    10 years

  • +3 more secondary outcomes

Other Outcomes (3)

  • Influence of fogging lens on retinal sensitivity to given trigger (Goldman III) on standard automated and RareBit perimetry

    1 day

  • Influence of tiredness on retinal sensitivity to given trigger (Goldman III) on standard automated and RareBit perimetry

    1 day

  • Peripapillar and macular vessels density

    5 years

Study Arms (4)

Control group

Sleep apnea using CEPAP

Sleep apnea not using CEPAP

Glaucoma control group

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • pregnant and breastfeeding persons

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Ophthalmology

Wroclaw, 50-556, Poland

Location

Related Publications (2)

  • 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.

    PMID: 19639754BACKGROUND

  • 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.

    PMID: 18321579BACKGROUND

MeSH Terms

Conditions

Sleep Apnea SyndromesGlaucomaOcular Hypertension

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesEye Diseases

Study Officials

  • Marta Misiuk-Hojło, Professor

    Wrocław Medical University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Investigator

Study Record Dates

First Submitted

April 14, 2019

First Posted

April 26, 2019

Study Start

October 1, 2012

Primary Completion

December 1, 2022

Study Completion (Estimated)

October 1, 2027

Last Updated

November 4, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Available IPD Datasets

DDLS - reference Access

Locations

PL(1)