Clinical Trial: Amylase and Hypersomnia

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

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

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.


Detailed Summary:
Sponsor: Hospices Civils de Lyon

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.
  • 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.


Original Secondary Outcome: Same as current

Information By: Hospices Civils de Lyon

Dates:
Date Received: August 12, 2013
Date Started: January 2013
Date Completion: November 2014
Last Updated: June 26, 2014
Last Verified: June 2014