Trials Sponsors Conditions Drugs Pricing

Conditions

Malformation Brain

Outcome Measures

Primary Outcomes (1)

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 (3)

volume of posterior cranial fossae
3 years
airway volume
3 years
area of cranial base foramina
3 years

Study Arms (2)

Malformation Chiari 1

Magnetic Resonance

Diagnostic Test: Magnetic ResonanceDiagnostic Test: Polysomnographic evaluation

Malformation Chiari 2

Magnetic Resonance

Diagnostic Test: Magnetic ResonanceDiagnostic Test: Polysomnographic evaluation

Interventions

Magnetic ResonanceDiagnostic test

Magnetic Resonance

Malformation Chiari 1Malformation Chiari 2

Polysomnographic evaluationDiagnostic test

Polysomnographic evaluation

Malformation Chiari 1

Eligibility Criteria

Age3 Years - 18 Years

Sexall

Healthy VolunteersYes

Age GroupsChild (0-17), Adult (18-64)

Sampling MethodNon-Probability Sample

Study Population

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

You may qualify if:

Children (males or females) aged between 3 years and 18 years.

Sponsors & Collaborators

Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Otherlead

Study Sites (1)

Fondazione Policlinico Gemelli IRCCS

Rome, Italy, 00168, Italy

RECRUITING

Marina Cicerone, MDCONTACT3484745545 ext. +39 marina.cicerone@policlinicogemelli.it

MeSH Terms

Interventions

Magnetic Resonance Imaging

Intervention Hierarchy (Ancestors)

TomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

Rosalinda Calandrelli, MD
Fondazione Policlinico A. Gemelli IRCCS
PRINCIPAL INVESTIGATOR

Central Study Contacts

Rosalinda Calandrelli, MD

CONTACT

3385417971 rosalinda.calandrelli@policlinicogemelli.it

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Principal Investigator

Study Record Dates

First Submitted

June 8, 2023

First Posted

June 22, 2023

Study Start

June 8, 2023

Actual (reported)

Primary Completion

June 8, 2025

Estimated (date passed)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (2)

Malformation Chiari 1

Malformation Chiari 2

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (2)

Malformation Chiari 1

Malformation Chiari 2

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations