Characterization of Sleep Features in Pediatric Patients With Septa-optic Dysplasia

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 3
Maximum Age: 18
Healthy Volunteers: f
View:

• 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

• 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

• 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

Locations
Other Locations
Italy
IRCCS Casimiro Mondino Foundation
RECRUITING
Pavia
Time Frame
Start Date: 2023-12-20
Estimated Completion Date: 2025-05-20
Participants
Target number of participants: 45
Treatments
Patients with Septo-optic dysplasia, visual deficit and agenesis of corpus callosum
* 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
Sponsors
Leads: IRCCS National Neurological Institute C. Mondino Foundation

This content was sourced from clinicaltrials.gov