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

Recruiting

• Conditions: Malformation Brain
• Interventions: Diagnostic Test: Magnetic Resonance; Diagnostic Test: Polysomnographic evaluation

• Registration Number: NCT05913297
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2023-06
• Study Start: 2023-06-08
• Study First Submitted: 2023-06-08
• Study First Submitted QC: 2023-06-18
• Last Update Submitted: 2023-06-18
• Study First Posted: 2023-06-22
• Last Update Posted: 2023-06-22
• Primary Completion: 2025-06-08
• Study Completion: 2026-06-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 138

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Malformation Chiari 2	Magnetic Resonance	Magnetic Resonance
Malformation Chiari 1	Magnetic Resonance	Magnetic Resonance
Malformation Chiari 1	Polysomnographic evaluation	Magnetic Resonance
Malformation Chiari 2	Polysomnographic evaluation	Magnetic Resonance

Primary Outcome Measures

Name	Time	Method
prevalence of SDB	3 years	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.

Secondary Outcome Measures

Name	Time	Method
volume of posterior cranial fossae	3 years	Evaluation of the volume of posterior cranial fossae CM-1 and CM-2, respectively, compared to an age-matched control group.
airway volume	3 years	Evaluation of the airway volume, in CM-1 and CM-2, respectively, compared to an age-matched control group
area of cranial base foramina	3 years	Evaluation of the area of cranial base foramina in CM-1 and CM-2, respectively, compared to an age-matched control group

Trial Locations

Locations (1)

Fondazione Policlinico Gemelli IRCCS; 🇮🇹 Rome, Italy