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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05913297

Acronym

CHDSB

Enrollment

138

Registered

2023-06-22

Start date

2023-06-08

Completion date

2026-06-08

Last updated

2025-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malformation Brain

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.

Interventions

DIAGNOSTIC_TESTMagnetic Resonance

Magnetic Resonance

DIAGNOSTIC_TESTPolysomnographic evaluation

Polysomnographic evaluation

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

3 Years to 18 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Italy

Contacts

Primary ContactRosalinda Calandrelli, MD

rosalinda.calandrelli@policlinicogemelli.it3385417971

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026