Prevalence and Clinical Impact of Sleep-Disordered Breathing in Children With Cerebral Palsy at Increased Risk of Respiratory Disorders
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 9
- 主要终点
- Number of Participants with obstructive sleep apnea in the study group
研究概览
简要总结
Currently, there are few and qualitatively unsatisfactory epidemiological data on the prevalence of sleep-disordered breathing (SDB) in children with cerebral palsy (CP).
The investigators aim to conduct a multicentre retrospective study to assess the presence of SDB in children with CP undergoing sleep studies (polysomnography or polygraphy).
详细描述
A recent review of the scientific literature shows that in the 61 studies on sleep-disordered breathing (SDB) in children with cerebral palsy (CP), epidemiological data on the diagnosis of SDB are scarce and of unsatisfactory quality, as the data are mainly based on the use of targeted questionnaires such as the Pediatric Sleep Questionnaire (PSQ). A study published by Garcia in Developmental Medicine and Child Neurology in 2016 shows that children with CP, especially if they have epilepsy as a comorbidity, have a higher risk of SDB than healthy children.
In a study published in the Annals of Indian Academy of Neurology in 2013, Elsayed found that children with CP are at higher risk for SDB with increasing age, with a higher incidence in the school-age group than in the preschool age group. In the same study, the investigator observed a direct correlation between the severity of motor impairment (levels IV and V versus levels I - III of the Gross Motor Function Classification System scale, GMFCS) and the risk of SDB.
Dum found in 2023 in the Journal of Child Neurology a 2.91-fold (p < 0.001) increased risk of SDB in obese individuals with CP compared to normal weight individuals with CP.
In a retrospective study published in Sleep and Breathing in 2024, Kalyoncu showed good sensitivity (88.8%) of the PSQ in patients with CP, but unacceptable specificity of this instrument (30.7%) compared to polysomnography.
The primary objective of the proposed multicentre retrospective study is to assess the prevalence of SDB in children with diagnosed CP and suspected SDB who underwent polygraphic or polysomnographic examination in the period from 01/01/2020 to 12/31/2023.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 0 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged less than 18 at the time of the sleep study
- •A diagnosis of Cerebral palsy
- •Written informed consent
- •Underwent a sleep study at one of the centers participating in the study during the reporting period (January 2020-December 2023)
排除标准
- 未提供
结局指标
主要结局
Number of Participants with obstructive sleep apnea in the study group
时间窗: The primary outcome measure refers to the first or only sleep study performed by participants in the time interval between January 2020 and December 2023.
According to the American Academy of Sleep Medicine (AASM), pediatric obstructive sleep apnea (OSA) is diagnosed and classified based on the Apnea-Hypopnea Index (AHI) in the sleep study (polysomnography or polygraphy), which quantifies the number of apnea and hypopnea events per hour of sleep. The sleep study is diagnosed: Normal if AHI \< 1 event per hour; Mild OSA if AHI is between 1 and 5 events per hour; Moderate OSA if AHI is between 5 and 10 events per hour and Severe OSA if AHI is greater than 10 events per hour.
次要结局
未报告次要终点
研究者
GUIDO CAMANNI
Medical Doctor
Istituto Serafico per sordomuti e per ciechi