Assessing the impact of Chiari malformations on children's airways and sleep disorders
Quantitative Neuroradiological Assessment of the Airways, Cranial Base Foramina, and Posterior Cranial Fossae in Children with Chiari Malformation: Relationship with Sleep Disorders
This study is trying to see how Chiari malformations in children affect their breathing during sleep and if there are any links to changes in their airway structures.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 138 (estimated) |
| Ages | 3 Years to 18 Years |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Rome, Italy) |
| Trial ID | NCT05913297 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate sleep-disordered breathing (SDB) in children diagnosed with Chiari Malformation Type 1 and Type 2. The researchers will use magnetic resonance imaging and polysomnographic evaluations to assess the relationship between SDB severity and various anatomical features of the airways and cranial base. The study will stratify SDB into central and obstructive types and analyze the volume of the posterior cranial fossae and airway structures in both patient groups. The goal is to establish correlations between SDB and morphological anomalies associated with Chiari malformations.
Who should consider this trial
Good fit: Ideal candidates include children aged 3 to 18 years with a clinical diagnosis of Chiari Malformation Type 1 or Type 2.
Not a fit: Patients with Chiari Malformations associated with neurological diseases, craniofacial malformations, or other specified exclusions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of sleep disorders in children with Chiari malformations.
How similar studies have performed: While there is limited data on similar studies, the approach of correlating anatomical features with sleep disorders in Chiari malformations is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Rome, Italy
- Fondazione Policlinico Gemelli IRCCS — Rome, Italy, Italy (Recruiting)
Study contacts
- Principal investigator: Rosalinda Calandrelli, MD — Fondazione Policlinico A. Gemelli IRCCS
- Study coordinator: Rosalinda Calandrelli, MD
- Email: rosalinda.calandrelli@policlinicogemelli.it
- Phone: 3385417971
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.