Amylase and Hypersomnia

N/ACompletedNCT01926405

Hospices Civils de Lyon54 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Hypersomnia in Children

Interventions

Eligibility

Sex: ALLMin age: 6 YearsMax age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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).

Outcomes

Primary Outcomes

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.

Time frame: 3 days

Secondary Outcomes

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.

Time frame: 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.

Time frame: 3 days

Amylase and Hypersomnia

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes