Analysis of New Salivary Biomarkers to Evaluate Excessive Diurnal Sleepiness in Children With Hypersomnia (BIOSOM)

  • STATUS
    Recruiting
  • End date
    Apr 11, 2025
  • participants needed
    98
  • sponsor
    Hospices Civils de Lyon
Updated on 6 May 2022

Summary

Excessive diurnal sleepiness is characterized by an incapacity to stay awake, in favour of sleep occurrence. This sleepiness might be secondary to a sleep disorder; when it is not the case, it is primary hypersomnia (including narcolepsy and idiopathic hypersomnia).

To date, objective measures of sleepiness can only be achieved in laboratory. Subjective techniques as scales and questionnaires are highly sensitive to inter-individual differences and cannot constitute a reliable diagnosis tool of sleepiness.

Recent studies suggested that some salivary biomarkers are sensitive to sleep characteristics and thus, may allow the objective and easy evaluation of sleepiness.

The objective of the study is to explore the usability of salivary biomarkers (a-amylase and oxalate) as a new non-invasive technique to evaluate sleepiness and to diagnose primary hypersomnia in children.

The hypothesis of this study is that there will be a modification of salivary biomarkers concentrations with the variations of diurnal sleepiness.

Details
Condition Hypersomnia, Sleepiness, Excessive Daytime
Treatment Saliva samples, Epworth Sleepiness Scale, Stanford sleepiness scale, Karolinska Sleepiness Scale, BLAST test
Clinical Study IdentifierNCT05183464
SponsorHospices Civils de Lyon
Last Modified on6 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Children with excessive diurnal sleepiness hospitalized for an evaluation of hypersomnia symptoms
Age> 6 years old and <18 years old
Non opposition by both parents

Exclusion Criteria

Opposition of the child or parents to participate
Patients under measure of deprivation of rights and liberty
Clear my responses

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