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

Civil Hospices of Lyon

Status: Completed

Conditions: Sleepiness, Excessive Daytime; Hypersomnia

Treatments: Behavioral: Stanford sleepiness scale; Behavioral: Epworth Sleepiness Scale; Biological: saliva samples; Behavioral: BLAST test; Behavioral: Karolinska Sleepiness Scale

Study type: Observational

Funder types: Other

Identifiers

NCT05183464

69HCL21_1119

2021-A02740-41 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 116 patients

Sex: All

Ages: 6 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

116 participants in 2 patient groups

Children with primary hypersomnia

Description:

Children with primary hypersomnia, i.e. narcolepsy or idiopathic hypersomnia

Treatment:

Behavioral: BLAST test

Behavioral: Karolinska Sleepiness Scale

Biological: saliva samples

Behavioral: Epworth Sleepiness Scale

Behavioral: Stanford sleepiness scale

Children with secondary hypersomnia

Description:

Children with a secondary hypersomnia, i.e. caused by sleep deprivation, a psychiatric disorder, sleep fragmentation, circadian delay.

Treatment:

Behavioral: BLAST test

Behavioral: Karolinska Sleepiness Scale

Biological: saliva samples

Behavioral: Epworth Sleepiness Scale

Behavioral: Stanford sleepiness scale