Sleep Profile of Patients With Septo-optic Dysplasia

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

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: 1. identify which factors such as clinical and neuroanatomical features including sensory experience influence sleep outcome and how 2. describe melatonin profile of patients with SOD 3. describe sleep EEG of patients with SOD Three groups of patients will be included: - Group A: patients with septo-optic dysplasia - Group B: patients with disorder of peripheral visual system - Group C: patients with Corpus Callosum agenesis 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: - administration of standardized sleep questionnaires (Pittsburgh Sleep Quality Index: self-completed questionnaire assessing sleep quality over a 1-month time interval;Epworth Sleepiness Scale: self-completed questionnaire assessing daytime sleepiness; Children sleep habits questionnaire) - 7 days actigraph recording through wearing of Actiwatch spectrum plus at home - Performance of Sleep EEG - Performance of blood and salivary sampling for melatonin dosing (for each subject, one 4 mL blood and one 2 mL saliva samples will be collected at each assessment) ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06262152
Study type	Observational
Source	IRCCS National Neurological Institute "C. Mondino" Foundation
Contact
Status	Recruiting
Phase
Start date	December 20, 2023
Completion date	May 20, 2025

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.