Status:
RECRUITING
Neuroradiology Assesses Chiari Malformation's Impact on Airways, Cranial Base, and Sleep Disorders in Children.
Lead Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Conditions:
Malformation Brain
Eligibility:
All Genders
3-18 years
Brief Summary
The severity of sleep disorders in patients with Chiari malformations can vary. The investigators propose to establish a correlation between the severity of sleep-disordered breathing (SDB) and the qu...
Detailed Description
Primary objective of the study is the evaluation of sleep-disordered breathing (SDB) in two distinct pediatric populations of patients with Chiari Malformation Type 1 (CM-I) and Chiari Malformation Ty...
Eligibility Criteria
Inclusion Criteria:
- Children (males or females) aged between 3 years and 18 years.
- Clinical diagnosis of Chiari malformation 1 and 2.
- Presence of informed consent for the initial clinical evaluation. The investigators commit to providing appropriate informational sheets to the parents of the patients (for those included in the study) during the initial clinical evaluation.
Exclusion Criteria:
- Chiari Malformation I and II associated with neurological diseases or craniofacial malformations.
- Cranial trauma or cardiac arrest.
- Administration of centrally acting medications within 2 weeks prior to the study, except for antiepileptic treatment for patients who have had seizures.
- Associated brain and cranial base tumors.
- Refusal to sign the informed consent for the initial clinical evaluation. The investigators commit to providing appropriate informational sheets to the parents of the patients (for those included in the study) during the initial clinical evaluation.
Key Trial Info
Start Date :
June 8 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 8 2026
Estimated Enrollment :
138 Patients enrolled
Trial Details
Trial ID
NCT05913297
Start Date
June 8 2023
End Date
June 8 2026
Last Update
February 27 2025
Active Locations (1)
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1
Fondazione Policlinico Gemelli IRCCS
Rome, Italy, Italy, 00168