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Hypersomnia in Children | Amylase and Hypersomnia

Hypersomnia in Children research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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).

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Hypersomnia in Children

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Procedure:saliva collectioncollection of saliva

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Subjects with narcolepsy or with idiopathic hypersomnia

Control patients with no sleeping disorder

Study Status

Completed

Start Date: January 2013

Completed Date: September 2016

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Determination of the expression and enzymatic activity of salivary amylase.

Secondary Outcome: Measurement of the mean sleep onset latency using the Multiple Sleep Latency Test (MSLT)

Study sponsors, principal investigator, and references

Principal Investigator:

Lead Sponsor: Hospices Civils de Lyon

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01926405

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