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NCT Number: NCT01926405

Amylase and Hypersomnia

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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Key information

Conditions

Hypersomnia in Children Disorders of Excessive Somnolence Dyssomnias Mental Disorders Narcolepsy Nervous System Diseases Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Femme-Mère-Enfant, Exploration et pathologie du sommeil

Bron, 69677, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Saliva collection

Procedure

collection of saliva

Primary outcomes

  1. Determination of the expression and enzymatic activity of salivary amylase.

    Time frame: 3 days

    Show an increase of salivary amylase for children with hypersomnia or narcolepsy compared to a group of children matched on age and sex.

Secondary outcomes

  1. Measurement of the mean sleep onset latency using the Multiple Sleep Latency Test (MSLT)

    Time frame: 3 days

    To highlight a correlation between the degree of somnolence measured by MSLT and the rate of salivary amylase.

  2. Measurement of the somnolence using Epworth and Karolinska scales

    Time frame: 3 days

    To highlight a correlation between the degree of somnolence measured by the scales and the rate of salivary amylase.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: Amylase

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Aug 20, 2013
Registry last updated
Feb 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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