Clinical trial NCT05913297: Neuroradiology Assesses Chiari Malformation's Impact on Airways, Cranial Base, and Sleep Disorders in Children.
Official title: Quantitative Neuroradiological Assessment of the Airways, Cranial Base Foramina, and Posterior Cranial Fossae in Children with Chiari Malformation: Relationship with Sleep Disorders
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Malformation Brain
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-06-22
Enrollment: 138
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children (males or females) aged between 3 years and 18 years. Clinical diagnosis of Chiari malformation 1 and 2.

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

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 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.

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.

Primary outcomes:
measure: prevalence of SDB
timeFrame: 3 years
Secondary outcomes:
measure: volume of posterior cranial fossae
timeFrame: 3 years
measure: airway volume
timeFrame: 3 years
measure: area of cranial base foramina
timeFrame: 3 years
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Fondazione Policlinico Gemelli IRCCS
Study officials:
affiliation: Fondazione Policlinico A. Gemelli IRCCS
name: Rosalinda Calandrelli, MD
role: PRINCIPAL_INVESTIGATOR
References: