Epidemiology (and Natural History) of Sleep Disordered Breathing and Respiratory Support in Children and Young People With Cerebral Palsy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Prevelance
研究概览
简要总结
Cerebral palsy (CP) refers to a non-progressive movement disorder, which occurs due to damage to the developing brain around the time of birth. Symptoms of sleep disordered breathing (SDB) include noisy breathing during sleep,increased day-time sleepiness and reduced energy levels. In the long term, SDB might have an effect on the brain and learning, as well as putting strain on the heart.
Children with CP have a higher risk of sleep breathing problems compared to typically-developing children, and the negative impact of sleep disturbance in children with CP on their family members/carers' sleep and mental health cannot be understated. Early recognition and management of SDB is important for children with CP to give these children the best possible sleep quality, and to maximise learning potential.
SDB in children with CP is often under-recognised and under-treated. Treatment of SDB in children with CP might involve wearing a mask that delivers pressurised air to hold open a child's airway and make breathing easier when they are asleep. This is called 'respiratory support' which can be continuous pressure (CPAP) or non-invasive ventilation (NIV) which is pressure support with a back-up breathing rate. There is limited knowledge on the appropriate indications or timing to use them.
Though respiratory support in children with CP is proven to help with breathing during sleep, its impact on quality of life, number of hospital admissions or frequency of chest infections is unknown.
This study will look at the number of children with CP on respiratory support across the UK, as well as the number of children newly diagnosed with SDB and/or established on respiratory support over a 1-year period. This study will also explore socioeconomic factors that might influence access of sleep services and the perceived facilitators and barriers to successfully initiating respiratory support in children with CP.
详细描述
The study will be conducted as a nationwide UK Sleep Surveillance Survey of children with cerebral palsy. It will be conducted as a two-part survey (UK-wide point prevalence survey and UK-wide Incidence self-reporting form).
There is no national registry of children with cerebral palsy (CP) which collects information on sleep or sleep disordered breathing (SDB) for the purpose of this study. Hence, the investigators will recruit all tertiary paediatric centres across the UK which offers sleep services to children. A single point of contact will be identified for further communication and to act as local champion for collecting the relevant information in each centre.
I) National point prevalence survey;
-
Single point of contact (PoCo) identified across tertiary paediatric centre which offer sleep services
-
Single questionnaire sent on pre-specified date to PoCo in each centre
-
Study will aim to;
-
assess number of children in each centre with CP established on respiratory support
-
gather information on practices in different centres pertaining to their assessment and management of children with CP and suspected SDB
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
- 1 Month 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cases for Prevalence survey;
- •Any child aged ≤16 years old, with a confirmed diagnosis of cerebral palsy
- •On respiratory support on the date of prevalence survey
- •Cases for Incidence self-reporting form;
- •Any Child aged ≤16 years old, with confirmed diagnosis of cerebral palsy
- •Had sleep studies for suspected sleep disordered breathing within the preceding calendar month
- •Any Child aged ≤16 years old, with a confirmed diagnosis of cerebral palsy
- •Initiated respiratory support (CPAP or NIV or invasive tracheostomy ventilation) in the preceding month
排除标准
- •(For prevalence survey and incidence self-reporting form)
- •Any patient aged >16 years old
- •Patient does not have a confirmed diagnosis of cerebral palsy
结局指标
主要结局
Prevelance
时间窗: Day 1 of study
Identify the prevalence of children with cerebral palsy on respiratory support across the UK
Incidence
时间窗: 13 months
Identify the incidence of children with CP newly diagnosed with sleep disordered breathing across the UK
次要结局
- Screening questionnaire(13 months)
- Types of sleep studies(13 months)
- Types of respiratory support(13 months)
- Indications for starting respiratory support(13 months)
- Social deprivation(13 months)
- Ethnicity(13 months)
- Geographical location(13 months)
- Facilitators(13 months)
- Barriers(13 months)