Actively Recruiting
Quantitative Neuroradiological Assessment of the Airways, Cranial Base Foramina, and Posterior Cranial Fossae in Children with Chiari Malformation: Relationship with Sleep Disorders
Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2025-02-27
138
Participants Needed
1
Research Sites
52 weeks
Total Duration
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AI-Summary
What this Trial Is About
Researchers are investigating how sleep disorders are related to structural differences in children with Chiari Malformation Types 1 and 2. The study aims to understand the connection between sleep-disordered breathing (SDB) severity and measurements of airways, cranial base openings, and the volume of the back part of the skull. This study focuses on pediatric patients to provide insights into how these brain malformations may impact breathing during sleep. Participants will undergo diagnostic tests including magnetic resonance imaging (MRI) to measure the volume of the posterior cranial fossae, airway size, and cranial base foramina area. They will also have polysomnographic evaluations to assess the presence and type of sleep-disordered breathing, distinguishing between central and obstructive origins. The study compares two groups of children with Chiari Malformation Type 1 and Type 2. During the study, children will be closely monitored through these imaging and sleep tests over a period of three years. Researchers will measure the prevalence of sleep-disordered breathing and analyze how it relates to anatomical differences in the brain and airway structures. The study includes clinical evaluations and informed consent processes, allowing careful observation of sleep breathing patterns and brain structure relationships in this young population.
CONDITIONS
Brief Title
Neuroradiology Assesses Chiari Malformation's Impact on Airways, Cranial Base, and Sleep Disorders in Children.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 with informational sheets provided to parents
You will not qualify if you...
- Chiari Malformation I and II associated with neurological diseases or craniofacial malformations
- History of cranial trauma or cardiac arrest
- Use of centrally acting medications within 2 weeks prior to the study, except antiepileptic treatment for seizures
- Presence of associated brain and cranial base tumors
- Refusal to sign the informed consent for the initial clinical evaluation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 years
Participants undergo Magnetic Resonance imaging and polysomnographic evaluation to assess the airways, cranial base foramina, and posterior cranial fossae, as well as sleep-disordered breathing.
Initial diagnostic visits and periodic follow-up assessments
Duration - Up to 3 years
Participants are observed over time to evaluate the prevalence of sleep-disordered breathing and related anatomical features.
Periodic visits during the study period
Trial Site Locations
Total: 1 location
1
Fondazione Policlinico Gemelli IRCCS
Rome, Italy, Italy, 00168
Actively Recruiting
Research Team
R
Rosalinda Calandrelli, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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