Clinical trial NCT01926405: Amylase and Hypersomnia
Official title: Evaluation of Excessive Diurnal Sleepiness by the Expression and Activity of Salivary Amylase in Children With Hypersomnia.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypersomnia in Children
Keywords: hypersomnia
narcolepsy
amylase
salivary sampling
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2013-08-20
Enrollment: 54
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: 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).

Primary outcomes:
measure: Determination of the expression and enzymatic activity of salivary amylase.
timeFrame: 3 days
Secondary outcomes:
measure: Measurement of the mean sleep onset latency using the Multiple Sleep Latency Test (MSLT)
timeFrame: 3 days
measure: Measurement of the somnolence using Epworth and Karolinska scales
timeFrame: 3 days
Other outcomes:
Locations:
city: Bron
country: France
facility: Hôpital Femme-Mère-Enfant, Exploration et pathologie du sommeil
Study officials:
References: