Neuroradiology Assesses Chiari Malformation's Impact on Airways, Cranial Base, and Sleep Disorders in Children. (CHDSB)

Institute of Hospitalization and Scientific Care (IRCCS)

Status

Enrolling

Conditions

Malformation Brain

Treatments

Diagnostic Test: Magnetic Resonance

Diagnostic Test: Polysomnographic evaluation

Study type

Observational

Funder types

Other

Identifiers

NCT05913297

5791 NO PROFIT

Details and patient eligibility

About

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 quantitative neuroradiological data of the airways, cranial base foramina, and posterior cranial fossae

Full 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 Type 2 (CM-II).

Secondary objectives:

Stratify the presence of SDB into central and obstructive origins in the two study populations.

Assess the volume of posterior cranial fossae, airway volume, and area of cranial base foramina in both groups.

Determine the relationships between SDB and morphological-quantitative anomalies associated with CM.

Enrollment

138 estimated patients

Sex

All

Ages

3 to 18 years old

Volunteers

Accepts Healthy Volunteers

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.