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临床试验/NCT03103841
NCT03103841已完成不适用

Investigation of Sleep Quality and Prevalence of Sleep-disordered Breathing in Children and Young People With Epilepsy

NHS Lothian1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2017年3月31日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
NHS Lothian
入组人数
72
试验地点
1
主要终点
Apnea/Hypopnea index

研究概览

简要总结

Obstructive sleep apnoea (OSA) is a condition that affects around one in 20 children. In children with OSA, repeated episodes of airway obstruction can severely disturb and fragment sleep, leading to subsequent cognitive and behavioural problems .

Epilepsy affects 60,000 children in the UK and up to 30% of children with epilepsy have learning problems. Evidence suggests that OSA is more common in children with epilepsy, such that sleep disturbance could account for some of the learning problems they experience.

The aim of this study is to determine the prevalence of OSA in children with epilepsy. The investigators plan carry out detailed sleep studies in children with epilepsy and healthy controls to determine if children with epilepsy are more likely to have OSA than healthy children of the same age.

OSA is almost always treatable and the benefits of detecting and treating the condition in healthy children are well-established. If OSA proves to be a common finding in children with epilepsy, it will be important to carry out further studies to see if treating the condition has beneficial effects on learning and behaviour. This project could lead doctors to target sleep-disordered breathing as a way of improving learning outcomes in children with epilepsy.

详细描述

Obstructive sleep apnoea (OSA) is a condition that affects around one in 20 children. In OSA, the muscles and soft tissues in the throat relax and collapse during sleep causing the upper airway to become blocked. Breathing is briefly interrupted, blood oxygen levels fall and this causes the child to wake and start breathing again. These episodes can happen many times a night causing severely disturbed sleep. Untreated OSA may leave children with daytime attention difficulties and problems with learning and behaviour. Epilepsy affects approximately 60,000 children in the UK and up to 30 per cent of these children have associated learning problems.

There is evidence, including pilot work undertaken by the study team to suggest that OSA is more common in children with epilepsy, in which case, sleep disturbance could account for some of the learning problems they experience. The aim of this study is to determine the prevalence of OSA in children with epilepsy.

The investigators plan to carry out detailed polysomnography sleep studies in 55 children with epilepsy and 28 healthy children (controls). These studies will measure the length and quality of sleep over one night spent at the hospital. Seizure activity during this period will be monitored by video recordings combined with electroencephalograms (EEG). Sleep-disordered will be assessed using a variety of tests to measure air-flow, lung expansion and blood oxygen levels. This study should help to determine if children with epilepsy are more likely to have OSA than healthy children of the same age. OSA is almost always treatable and the benefits of detecting and treating the condition in healthy children are well-established.

If OSA proves to be a common finding in children with epilepsy, it will be important to carry out further studies to see if treating the condition has beneficial effects on learning and behaviour. This project could lead doctors to target sleep-disordered breathing as a way of improving learning outcomes in children with epilepsy.

Children with epilepsy attending Royal Hospital for Children, Edinburgh will be invited to take part in the study. Children without epilepsy (controls) will also be recruited. The children without epilepsy are included because although there are statistics for incidence of OSA in the general population, information for all the measures of sleep the team will collect are not available.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
5 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of primary epilepsy and attendance at Epilepsy clinic

排除标准

  • Neurological co-morbidity affecting muscle tone OR any Respiratory co-morbidity including any history of asthma, airborne allergy or sleep-disordered breathing.

结局指标

主要结局

Apnea/Hypopnea index

时间窗: Over study duration - 2 years

Measurement of presence and severity of obstructive sleep apnoea

次要结局

  • Sleep Quality(Up to 10 hours)
  • Symptoms of OSA(Over study duration - 2 years)
  • Total Sleep Time(Over study duration - 2 years)
  • Sleep Efficiency(Over study duration - 2 years)
  • Daytime Sleepiness(Over study duration - 2 years)

研究者

发起方
NHS Lothian
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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