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

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

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

Study Overview

• Status: Recruiting
• Conditions: Malformation Brain
• Intervention / Treatment: Diagnostic test: Magnetic Resonance; Diagnostic test: Polysomnographic evaluation

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.

• Study Type: Observational
• Enrollment (Estimated): 138

Contacts and Locations

• Study Contact: Name: Rosalinda Calandrelli, MD; Phone Number: +39 3385417971; Email: rosalinda.calandrelli@policlinicogemelli.it

Study Locations

• Italy
  • Rome, Italy, 00168
    • Recruiting
    • Fondazione Policlinico Gemelli IRCCS
    • Contact: Marina Cicerone, MD; Phone Number: +39 3484745545; Email: marina.cicerone@policlinicogemelli.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Malformation Chiari 1; Magnetic Resonance	Diagnostic test: Magnetic Resonance; Magnetic Resonance; Diagnostic test: Polysomnographic evaluation; Polysomnographic evaluation
Malformation Chiari 2; Magnetic Resonance	Diagnostic test: Magnetic Resonance; Magnetic Resonance; Diagnostic test: Polysomnographic evaluation; Polysomnographic evaluation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 years
airway volume	Evaluation of the airway volume, in CM-1 and CM-2, respectively, compared to an age-matched control group	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	3 years

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Investigators: Principal Investigator: Rosalinda Calandrelli, MD, Fondazione Policlinico A. Gemelli IRCCS

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2023
• Primary Completion (Estimated): June 8, 2025
• Study Completion (Estimated): June 8, 2026

Study Registration Dates

• First Submitted: June 8, 2023
• First Submitted That Met QC Criteria: June 18, 2023
• First Posted (Actual): June 22, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 25, 2025
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Nervous System Malformations; Neural Tube Defects; Congenital Abnormalities; Parasomnias; Sleep Wake Disorders; Arnold-Chiari Malformation
• Other Study ID Numbers: 5791 NO PROFIT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No