UnknownNot Applicable

Sleep Profile of Patients With Septo-optic Dysplasia

Italy45 participantsStarted 2023-12-20

Plain-language summary

The aim of this study is to evaluate sleep of patients with septo-optic dysplasia compared to patients with an isolated disorder of peripheral visual system and patients with corpus callosum agenesis since both visus defict and agenesis of corpus callosum might be present SOD but associated to other features / structural and functional anomalies. Included patients and their caregivers will be asked to compile standardize sleep questionnaires and a sleep screening through an interview will be scheduled. Patients will be asked to wear an actigraph on their non-dominant hand wrist for 7 days.

Who can participate

Age range

3 Years – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Sleep profile ( Sleep quality, sleep efficiency) of patients with SOD

Timeframe: 12 months

Trial details

NCT IDNCT06262152

SponsorIRCCS National Neurological Institute "C. Mondino" Foundation

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-01-20

View on ClinicalTrials.gov More Septo-Optic Dysplasia trials