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Amylase and Hypersomnia

Evaluation of Excessive Diurnal Sleepiness by the Expression and Activity of Salivary Amylase in Children With Hypersomnia.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01926405
Acronym
Amylase
Enrollment
54
Registered
2013-08-20
Start date
2013-01-31
Completion date
2016-09-30
Last updated
2018-02-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypersomnia in Children

Keywords

hypersomnia, narcolepsy, amylase, salivary sampling

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.

Interventions

PROCEDUREsaliva collection

collection of saliva

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
Yes

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).

Design outcomes

Primary

MeasureTime frameDescription
Determination of the expression and enzymatic activity of salivary amylase.3 daysShow an increase of salivary amylase for children with hypersomnia or narcolepsy compared to a group of children matched on age and sex.

Secondary

MeasureTime frameDescription
Measurement of the mean sleep onset latency using the Multiple Sleep Latency Test (MSLT)3 daysTo highlight a correlation between the degree of somnolence measured by MSLT and the rate of salivary amylase.
Measurement of the somnolence using Epworth and Karolinska scales3 daysTo highlight a correlation between the degree of somnolence measured by the scales and the rate of salivary amylase.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026