Analysis of New Salivary Biomarkers to Evaluate Excessive Diurnal Sleepiness in Children With Hypersomnia (BIOSOM)
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- STATUS
- Recruiting
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- End date
- Apr 11, 2025
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- participants needed
- 98
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- sponsor
- Hospices Civils de Lyon
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 Identifier | NCT05183464 |
| Sponsor | Hospices Civils de Lyon |
| Last Modified on | 6 May 2022 |
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