Quantitative Neuroradiological Assessment of the Airways, Cranial Base Foramina, and Posterior Cranial Fossae in Children with Chiari Malformation: Relationship with Sleep Disorders
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- prevalence of SDB
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 3 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children (males or females) aged between 3 years and 18 years.
- •Clinical diagnosis of Chiari malformation 1 and
- •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.
排除标准
- •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.
结局指标
主要结局
prevalence of SDB
时间窗: 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.
次要结局
- volume of posterior cranial fossae(3 years)
- airway volume(3 years)
- area of cranial base foramina(3 years)
研究者
Calandrelli Rosalinda
Principal Investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS