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
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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Pavia, Pv, Italy
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported