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

NCT ID: NCT03928665

Last Updated: 2022-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-10-01

Study Completion Date

2027-10-01

Brief Summary

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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

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Conditions

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Sleep Apnea Glaucoma Ocular Hypertension

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Control group

No interventions assigned to this group

Sleep apnea using CEPAP

No interventions assigned to this group

Sleep apnea not using CEPAP

No interventions assigned to this group

Glaucoma control group

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wrocław University of Science and Technology

OTHER

Sponsor Role collaborator

Wroclaw Medical University

OTHER

Sponsor Role lead

Responsible Party

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Joanna Przeździecka-Dołyk

Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marta Misiuk-Hojło, Professor

Role: STUDY_CHAIR

Wrocław Medical University

Locations

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Department of Ophthalmology

Wroclaw, , Poland

Site Status

Countries

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Poland

References

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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.

Reference Type BACKGROUND
PMID: 19639754 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18321579 (View on PubMed)

Study Documents

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Document Type: DDLS - reference

View Document

Other Identifiers

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ST.2012.001

Identifier Type: -

Identifier Source: org_study_id

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