NCT06334640

Brief Summary

To assess the impact of sleep quality on chronic eyes diseases

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
186

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
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 Start

First participant enrolled

October 17, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 14, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 28, 2024

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

May 4, 2025

Status Verified

April 1, 2025

Enrollment Period

2.2 years

First QC Date

March 14, 2024

Last Update Submit

April 30, 2025

Conditions

Sleep Disorder

Outcome Measures

Primary Outcomes (1)

  • Proportion of sleep disorders in patients and healthy volunteers

    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

Study Arms (2)

Subjects with glaucoma and macular degeneration

Adults subjects affected by glaucoma and macular degeneration

Diagnostic Test: Three questionaires

Healthy volunteers

Adult healthy volunteers without eye disease

Diagnostic Test: Three questionaires

Interventions

Three questionairesDIAGNOSTIC_TEST

Berlin, Pittsburgh and Epworth tests administered during study visit

Healthy volunteersSubjects with glaucoma and macular degeneration

Eligibility Criteria

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

Outpatients attending our Institution for scheduled visits/examinations

You may qualify if:

  • Patients with macular degeneration or glaucoma or
  • Healthy volunteers

You may not qualify if:

  • \- Patients with other ocular disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istituto Auxologico Italiano IRCCS

Milan, 20145, Italy

RECRUITING

MeSH Terms

Conditions

Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Nervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Central Study Contacts

Paolo Milani, MD

CONTACT

+390261911dottpaolomilani@hotmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2024

First Posted

March 28, 2024

Study Start

October 17, 2023

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

May 4, 2025

Record last verified: 2025-04

Locations

IT(1)