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Search / Trial NCT06262152

Sleep Profile of Patients With Septo-optic Dysplasia

Launched by IRCCS NATIONAL NEUROLOGICAL INSTITUTE "C. MONDINO" FOUNDATION · Feb 8, 2024

Trial Information

Current as of July 22, 2025

Recruiting

Keywords

Sleep Actigraphy Brain Malformation Visual Deficit Sod Genesis Of Corpus Callous Pediatric Patients

ClinConnect Summary

This clinical trial is studying sleep patterns in patients with Septo-optic Dysplasia (SOD), a condition that can cause vision problems and other developmental issues. Researchers want to compare the sleep habits of children and teenagers with SOD to those with other visual disorders and brain conditions. The goal is to better understand how these conditions affect sleep, which is important for overall health and well-being.

To join the study, participants must be aged 3 to 18 and have a specific diagnosis related to SOD, isolated visual deficits, or agenesis of the corpus callosum, which is a brain condition. They will be asked to fill out sleep questionnaires, participate in an interview about sleep, and wear a small device on their wrist for a week to track their sleep patterns. The study is currently looking for participants, and it’s important that those interested discuss it with their caregivers to see if they meet the requirements. Overall, this research could help improve our understanding of sleep issues in these conditions, potentially leading to better care strategies.

Gender

ALL

Eligibility criteria

  • Inclusion criteria group A:
  • diagnosis of SOD or SOD plus syndrome with or without a defined genetic diagnosis
  • age 3-18 years
  • availability of at least 2 serial sleep EEGs performed during clinical follow-up
  • stable drug therapy in the last three months
  • Inclusion criteria group B:
  • diagnosis of congenital or early acquired isolated peripheral visual deficit with or without a known genetic diagnosis (e.g., congenital cataract, inherited retinal dystrophies, isolated eye maldevelopment).
  • age 3-18 years
  • grating or visual acuity \< 3/10
  • availability of serial sleep EEGs performed during clinical follow-up
  • stable drug therapy in the last three months
  • Inclusion criteria group C
  • isolated corpus callosum agenesis at brain MRI
  • age 3-18 years
  • availability of at least 2 serial sleep EEGs performed during clinical follow-up
  • stable drug therapy in the last three months
  • Exclusion criteria group A:
  • absence of informed consent
  • severe Intellectual disability and/or severe motor impairment
  • melatonin assumption
  • Exclusion criteria group B:
  • absence of informed consent
  • CNS involvement ( malformations/ lesions)
  • severe Intellectual disability and/or severe motor impairment
  • melatonin assumption
  • Exclusion criteria group C
  • absence of informed consent
  • severe Intellectual disability and/or severe motor impairment
  • melatonin assumption

About Irccs National Neurological Institute "C. Mondino" Foundation

The IRCCS National Neurological Institute "C. Mondino" Foundation is a prominent research institution in Italy dedicated to advancing the field of neurology through innovative clinical trials and scientific research. As a recognized IRCCS (Istituto di Ricovero e Cura a Carattere Scientifico), the foundation focuses on the diagnosis, treatment, and rehabilitation of neurological disorders, fostering collaboration among healthcare professionals, researchers, and academic institutions. Committed to translating cutting-edge research into clinical practice, the foundation aims to enhance patient care and improve outcomes for individuals affected by neurological diseases. Its rigorous approach to clinical trials ensures the highest standards of scientific integrity and patient safety.

Locations

Pavia, Pv, Italy

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported