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

Recruiting

• Conditions: Hypersomnia; Sleepiness, Excessive Daytime
• Interventions: Biological: saliva samples; Behavioral: Stanford sleepiness scale; Behavioral: Karolinska Sleepiness Scale; Behavioral: Epworth Sleepiness Scale; Behavioral: BLAST test

• Registration Number: NCT05183464
• Lead Sponsor: Hospices Civils de Lyon

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-12-21
• Study First Submitted QC: 2021-12-21
• Study First Posted: 2022-01-10
• Status Verified: 2022-04
• Study Start: 2022-04-11
• Last Update Submitted: 2022-04-12
• Last Update Posted: 2022-04-19
• Primary Completion: 2025-04-11
• Study Completion: 2025-04-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 98

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

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Exclusion Criteria

• Opposition of the child or parents to participate
• Patients under measure of deprivation of rights and liberty

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Children with primary hypersomnia	Stanford sleepiness scale	Children with primary hypersomnia, i.e. narcolepsy or idiopathic hypersomnia
Children with secondary hypersomnia	saliva samples	Children with a secondary hypersomnia, i.e. caused by sleep deprivation, a psychiatric disorder, sleep fragmentation, circadian delay.
Children with primary hypersomnia	saliva samples	Children with primary hypersomnia, i.e. narcolepsy or idiopathic hypersomnia
Children with primary hypersomnia	Epworth Sleepiness Scale	Children with primary hypersomnia, i.e. narcolepsy or idiopathic hypersomnia
Children with primary hypersomnia	BLAST test	Children with primary hypersomnia, i.e. narcolepsy or idiopathic hypersomnia
Children with secondary hypersomnia	Karolinska Sleepiness Scale	Children with a secondary hypersomnia, i.e. caused by sleep deprivation, a psychiatric disorder, sleep fragmentation, circadian delay.
Children with secondary hypersomnia	Epworth Sleepiness Scale	Children with a secondary hypersomnia, i.e. caused by sleep deprivation, a psychiatric disorder, sleep fragmentation, circadian delay.
Children with primary hypersomnia	Karolinska Sleepiness Scale	Children with primary hypersomnia, i.e. narcolepsy or idiopathic hypersomnia
Children with secondary hypersomnia	Stanford sleepiness scale	Children with a secondary hypersomnia, i.e. caused by sleep deprivation, a psychiatric disorder, sleep fragmentation, circadian delay.
Children with secondary hypersomnia	BLAST test	Children with a secondary hypersomnia, i.e. caused by sleep deprivation, a psychiatric disorder, sleep fragmentation, circadian delay.

Primary Outcome Measures

Name	Time	Method
Salivary a-amylase concentration (U/ml)	3 days following the inclusion	Salivary a-amylase concentrations will be collected with Salivette. Children will be asked to passively keep a piece of cotton in mouth that will absorb the saliva for one minute.

Trial Locations

Locations (1)

Hôpital Mère-Enfant - Service d'épileptologie clinique, des troubles du sommeil et de neurologie fonctionnelle de l'enfant; 🇫🇷 Bron, France