An observational study in Septo-Optic Dysplasia, Agenesis of Corpus Callosum and Blindness, sponsored by IRCCS National Neurological Institute "C. Mondino" Foundation. Recruiting at 1 site in Italy. Open to participants aged 3 Years to 18 Years. Per ClinicalTrials.gov, last updated 2024-02-15.
Sponsored by IRCCS National Neurological Institute "C. Mondino" Foundation · Observational
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.
The primary objective 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.
The secondary aims of this study are the following:
Three groups of patients will be included:
This is an observational monocentric study. The procedures in the study that are not included in current clinical practice in the follow-up pathway of the included patients are the following:
144 studies on the registry are indexed under Blindness; 33 are open to participants now.
This study's planned enrollment of 45 is below the median of 76 across 35 observational studies indexed under Blindness.
Browse Blindness studies →IRCCS National Neurological Institute "C. Mondino" Foundation is the lead sponsor of 57 studies on the registry; 20 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Three groups of patients will be included:
Inclusion criteria group A:
Inclusion criteria group B:
Inclusion criteria group C
Exclusion criteria group A:
Exclusion criteria group B:
Exclusion criteria group C
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
* 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
Diagnostic Test: Actigraphy, blood and salivary sample, and sleep evaluation
* For each subject, one 4 mL blood and one 2 mL saliva samples will be collected at each assessment. * 7 days actigraph recording through wearing of Actiwatch spectrum plus at home * Standardized sleep questionnaire administration
Sleep profile ( Sleep quality, sleep efficiency) of patients with SOD
SLEEP QUALITY will be assessed through standardized questionnaires :Pittsburgh Sleep Quality Index: self-completed questionnaire ;Epworth Sleepiness Scale: self-completed questionnaire assessing daytime sleepiness; Children sleep habits questionnaire . Sleep quality and sleep-wake cycle will be evaluated, namely Child's inability to go to bed, the delay in falling asleep, sleep duration, overnight awakenings, anxiety related to sleep, parasomnia, respiratory disorders, and daytime sleepiness. SLEEP EFFICIENCY will be measured by actigraphic assessment of sleep efficiency (the ratio of total sleep time to sleep period), total nighttime sleep duration, rest activity and number of awakenings.
Time frame: 12 months
melatonin profile of patients with SOD
For each subject, blood and and saliva samples will be collected and Serum and salivary concentrations of melatonin and of its main metabolite 6-hydroxymelatonin will be measured in samples collected from all patients by using a validated LC-MS method with minor modifications (Magliocco et al 2021).
Time frame: 12 months
Sleep EEG description of patients with SOD
A Sleep EEG recording will also be scheduled at the time of study inclusion/evaluation. Previously performed EEG will be revised. EEG assessment will include the analysis of background activity, presence/absence of physiological sleep elements, interictal discharges, sleep macrostructure and microstructure ( spindle characteristics).
Time frame: 12 months
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Dec 2023 to primary completion in Jan 2024, 1 month.
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IRCCS National Neurological Institute "C. Mondino" Foundation