Amylase and Hypersomnia

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of Excessive Diurnal Sleepiness by the Expression and Activity of Salivary Amylase in Children With Hypersomnia.

Conditions
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Hypersomnia in Children

Intervention / Treatment
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* Procedure: saliva collection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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).

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Subjects with narcolepsy or with idiopathic hypersomnia<br> | Procedure: saliva collection<br>* collection of saliva<br>|
| Other: Control patients with no sleeping disorder<br> | Procedure: saliva collection<br>* collection of saliva<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of the expression and enzymatic activity of salivary amylase. | Show an increase of salivary amylase for children with hypersomnia or narcolepsy compared to a group of children matched on age and sex. | 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of the mean sleep onset latency using the Multiple Sleep Latency Test (MSLT) | To highlight a correlation between the degree of somnolence measured by MSLT and the rate of salivary amylase. | 3 days | 
| Measurement of the somnolence using Epworth and Karolinska scales | To highlight a correlation between the degree of somnolence measured by the scales and the rate of salivary amylase. | 3 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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amylase, hypersomnia, narcolepsy, salivary sampling