Analysis of New Salivary Biomarkers to Evaluate Excessive Diurnal Sleepiness in Children with Hypersomnia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- Salivary a-amylase concentration (U/ml)
研究概览
简要总结
Excessive diurnal sleepiness is characterized by an incapacity to stay awake, in favour of sleep occurrence. This sleepiness might be secondary to a sleep disorder; when it is not the case, it is primary hypersomnia (including narcolepsy and idiopathic hypersomnia).
To date, objective measures of sleepiness can only be achieved in laboratory. Subjective techniques as scales and questionnaires are highly sensitive to inter-individual differences and cannot constitute a reliable diagnosis tool of sleepiness.
Recent studies suggested that some salivary biomarkers are sensitive to sleep characteristics and thus, may allow the objective and easy evaluation of sleepiness.
The objective of the study is to explore the usability of salivary biomarkers (a-amylase and oxalate) as a new non-invasive technique to evaluate sleepiness and to diagnose primary hypersomnia in children.
The hypothesis of this study is that there will be a modification of salivary biomarkers concentrations with the variations of diurnal sleepiness.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- 否
入选标准
- •Children with excessive diurnal sleepiness hospitalized for an evaluation of hypersomnia symptoms
- •Age> 6 years old and <18 years old
- •Non opposition by both parents
排除标准
- •Opposition of the child or parents to participate
- •Patients under measure of deprivation of rights and liberty
研究组 & 干预措施
Children with primary hypersomnia
Children with primary hypersomnia, i.e. narcolepsy or idiopathic hypersomnia
干预措施: saliva samples (Biological)
Children with primary hypersomnia
Children with primary hypersomnia, i.e. narcolepsy or idiopathic hypersomnia
干预措施: Stanford sleepiness scale (Behavioral)
Children with primary hypersomnia
Children with primary hypersomnia, i.e. narcolepsy or idiopathic hypersomnia
干预措施: Karolinska Sleepiness Scale (Behavioral)
Children with primary hypersomnia
Children with primary hypersomnia, i.e. narcolepsy or idiopathic hypersomnia
干预措施: Epworth Sleepiness Scale (Behavioral)
Children with primary hypersomnia
Children with primary hypersomnia, i.e. narcolepsy or idiopathic hypersomnia
干预措施: BLAST test (Behavioral)
Children with secondary hypersomnia
Children with a secondary hypersomnia, i.e. caused by sleep deprivation, a psychiatric disorder, sleep fragmentation, circadian delay.
干预措施: saliva samples (Biological)
Children with secondary hypersomnia
Children with a secondary hypersomnia, i.e. caused by sleep deprivation, a psychiatric disorder, sleep fragmentation, circadian delay.
干预措施: Stanford sleepiness scale (Behavioral)
Children with secondary hypersomnia
Children with a secondary hypersomnia, i.e. caused by sleep deprivation, a psychiatric disorder, sleep fragmentation, circadian delay.
干预措施: Karolinska Sleepiness Scale (Behavioral)
Children with secondary hypersomnia
Children with a secondary hypersomnia, i.e. caused by sleep deprivation, a psychiatric disorder, sleep fragmentation, circadian delay.
干预措施: Epworth Sleepiness Scale (Behavioral)
Children with secondary hypersomnia
Children with a secondary hypersomnia, i.e. caused by sleep deprivation, a psychiatric disorder, sleep fragmentation, circadian delay.
干预措施: BLAST test (Behavioral)
结局指标
主要结局
Salivary a-amylase concentration (U/ml)
时间窗: 3 days following the inclusion
Salivary a-amylase concentrations will be collected with Salivette. Children will be asked to passively keep a piece of cotton in mouth that will absorb the saliva for one minute.
次要结局
未报告次要终点