Sleeping Quality and Chronic Ocular Diseases (SONNO-OCU)

March 25, 2024 updated by: Istituto Auxologico Italiano

L'Impatto Del Sonno Nelle Patologie Croniche Oculari

To assess the impact of sleep quality on chronic eyes diseases

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

In this study 3 questionnaires will be distributed to outpatients attending the routine examinations : the Pittsburgh, the Berlin and the Epworth tests These questionnaires, once completed, will then be collected to be then transformed into digital files for the appropriate statistical evaluations and the drafting of the results and conclusions.

Study Type

Observational

Enrollment (Estimated)

186

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Milan, Italy, 20145
        • Recruiting
        • Istituto Auxologico Italiano IRCCS
        • Contact:
          • Paolo Milani, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Outpatients attending our Institution for scheduled visits/examinations

Description

Inclusion Criteria:

  • Patients with macular degeneration or glaucoma or
  • Healthy volunteers

Exclusion Criteria:

- Patients with other ocular disorders

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Subjects with glaucoma and macular degeneration
Adults subjects affected by glaucoma and macular degeneration
Diagnostic test: Three questionaires
Berlin, Pittsburgh and Epworth tests administered during study visit
Healthy volunteers
Adult healthy volunteers without eye disease
Diagnostic test: Three questionaires
Berlin, Pittsburgh and Epworth tests administered during study visit

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of sleep disorders in patients and healthy volunteers
Time Frame: At enrollment
To analyze the prevalence of sleep disorders in subjects affected by glaucoma and macular degeneration and in healthy volunteers as assessed by Berlin, Pittsburgh and Epworth questionnaires
At enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Auxologico Italiano

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 17, 2023

Primary Completion (Estimated)

October 17, 2024

Study Completion (Estimated)

October 17, 2025

Study Registration Dates

First Submitted

March 14, 2024

First Submitted That Met QC Criteria

March 25, 2024

First Posted (Actual)

March 28, 2024

Study Record Updates

Last Update Posted (Actual)

March 28, 2024

Last Update Submitted That Met QC Criteria

March 25, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 37C302

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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