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

Fondazione Policlinico Universitario Agostino Gemelli IRCCS138 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

138

Conditions

Malformation Brain

Interventions

Magnetic ResonanceDIAGNOSTIC_TEST

Magnetic Resonance

Polysomnographic evaluationDIAGNOSTIC_TEST

Polysomnographic evaluation

Eligibility

Sex: ALLMin age: 3 YearsMax age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Fondazione Policlinico Gemelli IRCCS

Rome, Italy, Italy

RECRUITING

Outcomes

Primary Outcomes

prevalence of SDB

The primary endpoint of the study is the prevalence of sleep-disordered breathing (SDB) in two distinct pediatric populations of patients with CM-I and CM-II.

Time frame: 3 years

Secondary Outcomes

volume of posterior cranial fossae

Evaluation of the volume of posterior cranial fossae CM-1 and CM-2, respectively, compared to an age-matched control group.

Time frame: 3 years

airway volume

Evaluation of the airway volume, in CM-1 and CM-2, respectively, compared to an age-matched control group

Time frame: 3 years

area of cranial base foramina

Evaluation of the area of cranial base foramina in CM-1 and CM-2, respectively, compared to an age-matched control group

Time frame: 3 years

Central Contacts

Rosalinda Calandrelli, MD

CONTACT

3385417971 rosalinda.calandrelli@policlinicogemelli.it

Data from ClinicalTrials.gov

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