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

NCT05913297 | Recruiting

• 1 other identifier: 5791 NO PROFIT
• Study Type: observational
• Target: 138
• Locations: 1 country
• Sites: 1

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

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 Resonance; Diagnostic Test: Polysomnographic evaluation

Malformation Chiari 2

Magnetic Resonance

Diagnostic Test: Magnetic Resonance; Diagnostic Test: Polysomnographic evaluation

Interventions

Magnetic Resonance DIAGNOSTIC_TEST

Magnetic Resonance

Malformation Chiari 1; Malformation Chiari 2

Polysomnographic evaluation DIAGNOSTIC_TEST

Polysomnographic evaluation

Malformation Chiari 1; Malformation Chiari 2

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Gemelli IRCCS

Rome, Italy, 00168, Italy

RECRUITING

MeSH Terms

Interventions

Magnetic Resonance Imaging

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

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
• Primary Completion: June 8, 2025
• Study Completion (Estimated): June 8, 2026
• Last Updated: February 27, 2025

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)