Amylase and Hypersomnia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2016-09-30

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.

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Detailed Description

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Conditions

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Hypersomnia in Children

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Subjects with narcolepsy or with idiopathic hypersomnia

Group Type OTHER

saliva collection

Intervention Type PROCEDURE

collection of saliva

Control patients with no sleeping disorder

Group Type OTHER

saliva collection

Intervention Type PROCEDURE

collection of saliva

Interventions

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saliva collection

collection of saliva

Intervention Type PROCEDURE

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).

Minimum Eligible Age

6 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes