Evaluation of Excessive Diurnal Sleepiness by the Expression and Activity of Salivary Amylase in Children With Hypersomnia.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Determination of the expression and enzymatic activity of salivary amylase.
研究概览
简要总结
Hypersomnia is defined as a reduced ability to remain awake during the day. There are basically two types of central hypersomnia: narcolepsy and idiopathic hypersomnia. Currently, the diagnosis of these sleep disorders is based on polysomnographic recordings which is difficult to access. Tests of sleepiness (Epworth, Karolinska) are subjective.
A biological marker of sleepiness, easily accessible and measurable, would be very useful for the diagnosis and therapeutic follow up of excessive diurnal sleepiness. Salivary secretions appear as good physiological markers. Studies have shown for healthy subjects, that the expression and activity of salivary amylase are increased when subjects are deprived of sleep.
The investigators propose to explore the usefulness of salivary biomarkers (including amylase) as a new non-invasive and simple technique for the assessment of excessive daytime sleepiness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects with hypersomnia (narcolepsy or idiopathic):
- •Children and adolescents with hypersomnia (according to ICSD diagnostic criteria 2); narcolepsy or idiopathic hypersomnia (with or without lengthening of sleep),
- •aged > 6 years and <18 years,
- •no treatment,
- •Parent consent
- •Control subjects:
- •healthy children and adolescents without any known pathology,
- •aged > 6 years and <18 years,
- •matched on sex and age> 6 years - <12 years,> 12 - <18 years)
- •Parent Consent
排除标准
- •Subjects with hypersomnia (narcolepsy or idiopathic):
- •Secondary narcolepsy,
- •Symptomatic hypersomnia,
- •Restless legs syndrome,
- •Sleep apnea syndrome,
- •Severe neurological, psychiatric, cognitive or endocrinological concomitant disease.
- •Control subjects:
- •Hypersomnia,
- •Restless legs syndrome,
- •Sleep apnea syndrome,
- •Severe neurological, psychiatric, cognitive or endocrinological concomitant disease,
- •Sleep disorder evaluated by a score > 70 on the Sleep Disturbance Scale for Children19,
- •Excessive daytime sleepiness according to Epworth scales (score > 10),
- •Abnormal sleep time according to the age (sleep diary).
研究组 & 干预措施
Subjects with narcolepsy or with idiopathic hypersomnia
干预措施: saliva collection (Procedure)
Control patients with no sleeping disorder
干预措施: saliva collection (Procedure)
结局指标
主要结局
Determination of the expression and enzymatic activity of salivary amylase.
时间窗: 3 days
Show an increase of salivary amylase for children with hypersomnia or narcolepsy compared to a group of children matched on age and sex.
次要结局
- Measurement of the somnolence using Epworth and Karolinska scales(3 days)
- Measurement of the mean sleep onset latency using the Multiple Sleep Latency Test (MSLT)(3 days)