NCT05913297

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

Quantitative Neuroradiological Assessment of the Airways, Cranial Base Foramina, and Posterior Cranial Fossae in Children with Chiari Malformation: Relationship with Sleep Disorders

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 138 (estimated)
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Academic / Other
• Sex: All
• Age: 3 Years – 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Malformation Brain

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Magnetic Resonance	Magnetic Resonance
DIAGNOSTIC_TEST	Polysomnographic evaluation	Polysomnographic evaluation

Timeline

• Start date: 2023-06-08
• Primary completion: 2025-06-08
• Completion: 2026-06-08
• First posted: 2023-06-22
• Last updated: 2025-02-27

Locations

1 site across 1 country: Italy