Neuroradiology Assesses Chiari Malformation's Impact on A... | NCT05913297

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

NCT05913297

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Status

Unknown status

Last Update Posted

Feb 27, 2025Actual

Enrollment

138Estimated

Phase

Not provided

Conditions

Malformation Brain

Interventions

Magnetic Resonance
Polysomnographic evaluation

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 8, 2023Actual

Primary Completion Date

Jun 8, 2025Estimated

Completion Date

Jun 8, 2026Estimated

First Submitted Date

Jun 8, 2023

First Submission Date that Met QC Criteria

Jun 18, 2023

First Posted Date

Jun 22, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 25, 2025

Last Update Posted Date

Feb 27, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Calandrelli Rosalinda, Principal Investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCSPrincipal Investigator

Lead Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCSOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

138Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Malformation Chiari 1		Magnetic Resonance	Diagnostic Test: Magnetic Resonance Diagnostic Test: Polysomnographic evaluation
Malformation Chiari 2		Magnetic Resonance	Diagnostic Test: Magnetic Resonance Diagnostic Test: Polysomnographic evaluation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Magnetic Resonance	Diagnostic Test	Magnetic Resonance	Malformation Chiari 1 Malformation Chiari 2

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Children (males or females) aged between 3 years and 18 years. Clinical diagnosis of Chiari malformation 1 and 2.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Rosalinda Calandrelli, MD	Contact	3385417971	+39	rosalinda.calandrelli@policlinicogemelli.it

Overall Officials

Name	Affiliation	Role
Rosalinda Calandrelli, MD	Fondazione Policlinico A. Gemelli IRCCS	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fondazione Policlinico Gemelli IRCCS	Recruiting	Rome	Italy	00168	Italy

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008279	Magnetic Resonance Imaging

Ancestor Terms

ID	Term
D014054	Tomography
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

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Browse Branches

Not provided