CHDSB: Neuroradiology Assesses Chiari Malformation's Impact on Airways, Cranial Base, and Sleep Disorders in Children.
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Malformation Chiari 1 Magnetic Resonance |
Diagnostic Test: Magnetic Resonance
Magnetic Resonance
Diagnostic Test: Polysomnographic evaluation
Polysomnographic evaluation
|
| Malformation Chiari 2 Magnetic Resonance |
Diagnostic Test: Magnetic Resonance
Magnetic Resonance
Diagnostic Test: Polysomnographic evaluation
Polysomnographic evaluation
|
Outcome Measures
Primary Outcome Measures
- prevalence of SDB [3 years]
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.
Secondary Outcome Measures
- volume of posterior cranial fossae [3 years]
Evaluation of the volume of posterior cranial fossae CM-1 and CM-2, respectively, compared to an age-matched control group.
- airway volume [3 years]
Evaluation of the airway volume, in CM-1 and CM-2, respectively, compared to an age-matched control group
- area of cranial base foramina [3 years]
Evaluation of the area of cranial base foramina in CM-1 and CM-2, respectively, compared to an age-matched control group
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Children (males or females) aged between 3 years and 18 years.
-
Clinical diagnosis of Chiari malformation 1 and 2.
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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:
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Chiari Malformation I and II associated with neurological diseases or craniofacial malformations.
-
Cranial trauma or cardiac arrest.
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Administration of centrally acting medications within 2 weeks prior to the study, except for antiepileptic treatment for patients who have had seizures.
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Associated brain and cranial base tumors.
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Fondazione Policlinico Gemelli IRCCS | Rome | Italy | 00168 |
Sponsors and Collaborators
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Investigators
- Principal Investigator: Rosalinda Calandrelli, MD, Fondazione Policlinico A. Gemelli IRCCS
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 5791 NO PROFIT