Amylase and Hypersomnia

Civil Hospices of Lyon

Status: Completed

Conditions: Hypersomnia in Children

Treatments: Procedure: saliva collection

Study type: Interventional

Funder types: Other

Identifiers

NCT01926405

2011.681

Details and patient eligibility

About

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.

Enrollment: 54 patients

Sex: All

Ages: 6 to 18 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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54 participants in 2 patient groups

Subjects with narcolepsy or with idiopathic hypersomnia

Other group

Treatment:

Procedure: saliva collection

Control patients with no sleeping disorder

Other group

Treatment:

Procedure: saliva collection