Evaluating sleep patterns in patients with septo-optic dysplasia
Characterization of Sleep Features in Pediatric Patients With Septa-optic Dysplasia
This study looks at the sleep patterns of people with septo-optic dysplasia to see how their sleep compares to those with other visual disorders and what factors might affect their sleep.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 45 (estimated) |
| Ages | 3 Years to 18 Years |
| Sex | All |
| Sponsor | IRCCS National Neurological Institute "C. Mondino" Foundation Academic / other |
| Locations | 1 site (Pavia, PV) |
| Trial ID | NCT06262152 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the sleep profiles of patients with septo-optic dysplasia (SOD) compared to those with isolated peripheral visual disorders and corpus callosum agenesis. Participants will complete standardized sleep questionnaires and wear an actigraph for seven days to monitor sleep patterns. Additionally, the study will explore factors influencing sleep outcomes, melatonin profiles, and sleep EEG characteristics in these patients. The research focuses on understanding how structural and functional anomalies affect sleep in these populations.
Who should consider this trial
Good fit: Ideal candidates include children aged 3-18 years diagnosed with septo-optic dysplasia, isolated peripheral visual deficits, or corpus callosum agenesis.
Not a fit: Patients with severe intellectual disabilities or those unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of sleep disturbances in patients with septo-optic dysplasia and related conditions.
How similar studies have performed: While there is limited data on sleep in this specific population, similar studies have shown the importance of sleep evaluation in patients with neurological conditions.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Pavia, PV
- IRCCS Casimiro Mondino Foundation — Pavia, Pv, Italy (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.