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

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.

Study Overview

• Status: Completed
• Conditions: Hypersomnia; Sleepiness, Excessive Daytime
• Intervention / Treatment: Biological: saliva samples; Behavioral: Stanford sleepiness scale; Behavioral: Karolinska Sleepiness Scale; Behavioral: Epworth Sleepiness Scale; Behavioral: BLAST test

• Study Type: Observational
• Enrollment (Actual): 116

Contacts and Locations

Study Locations

• France
  • Bron, France, 69677
    • Hôpital Mère-Enfant - Service d'épileptologie clinique, des troubles du sommeil et de neurologie fonctionnelle de l'enfant

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 14 years (Child, Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Children hospitalized for an evaluation of their excessive diurnal sleepiness will be included in this study.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Children with primary hypersomnia; Children with primary hypersomnia, i.e. narcolepsy or idiopathic hypersomnia	Biological: saliva samples; Collection of salivary a-amylase during the day (5 times a day: at 8:00 am, 9:00 am,1:00pm, 4:00pm and 8:00pm) with Salivette.; Behavioral: Stanford sleepiness scale; The Stanford Sleepiness Scale evaluates sleepiness at the time of the evaluation. The subjects have to choose the statement best representing their level of sleepiness on a scale ranging from 1 to 7: the higher the score, the higher the sleepiness. This scale will be submitted to the children before each salivary sampling (5 times a day: at 8:00 am, 9:00 am,1:00pm, 4:00pm and 8:00pm); Behavioral: Karolinska Sleepiness Scale; The Karolinska Sleepiness Scale assesses the perceived level of sleepiness at the time of the evaluation on a 9-points scale. The higher the score, the higher the sleepiness. This scale will be submitted to the children before each salivary sampling (5 times a day: at 8:00 am, 9:00 am,1:00pm, 4:00pm and 8:00pm); Behavioral: Epworth Sleepiness Scale; The Adapted Epworth Sleepiness Scale for children in which the item "falling asleep while in a car stopped in traffic" was replaced by "falling asleep at school" assesses the risk of falling asleep in 8 daily-life situations estimated on a 4-point Likert scale. The total score is the sum of the scores for the 8 items: a higher score represents greater sleepiness and the pathological threshold is higher than 10. This scale will be submitted to the children one time, at the onset of the hospitalization.; Behavioral: BLAST test; The BLAST (Bron/Lyon Attention Stability Test) is a computerized attention test evaluating brief lapses of attention with 4 measures: reaction times, errors and two composite measures (Stability and Intensity). The subjects have to detect the presence or the absence of a specific stimulus during approximatively 60 trials for 3 minutes. Normative data are available for both children and adults. This test is part of the neuropsychological evaluation, conducted the afternoon of the first day of hospitalization. The test is realized at 4:00pm.
Children with secondary hypersomnia; Children with a secondary hypersomnia, i.e. caused by sleep deprivation, a psychiatric disorder, sleep fragmentation, circadian delay.	Biological: saliva samples; Collection of salivary a-amylase during the day (5 times a day: at 8:00 am, 9:00 am,1:00pm, 4:00pm and 8:00pm) with Salivette.; Behavioral: Stanford sleepiness scale; The Stanford Sleepiness Scale evaluates sleepiness at the time of the evaluation. The subjects have to choose the statement best representing their level of sleepiness on a scale ranging from 1 to 7: the higher the score, the higher the sleepiness. This scale will be submitted to the children before each salivary sampling (5 times a day: at 8:00 am, 9:00 am,1:00pm, 4:00pm and 8:00pm); Behavioral: Karolinska Sleepiness Scale; The Karolinska Sleepiness Scale assesses the perceived level of sleepiness at the time of the evaluation on a 9-points scale. The higher the score, the higher the sleepiness. This scale will be submitted to the children before each salivary sampling (5 times a day: at 8:00 am, 9:00 am,1:00pm, 4:00pm and 8:00pm); Behavioral: Epworth Sleepiness Scale; The Adapted Epworth Sleepiness Scale for children in which the item "falling asleep while in a car stopped in traffic" was replaced by "falling asleep at school" assesses the risk of falling asleep in 8 daily-life situations estimated on a 4-point Likert scale. The total score is the sum of the scores for the 8 items: a higher score represents greater sleepiness and the pathological threshold is higher than 10. This scale will be submitted to the children one time, at the onset of the hospitalization.; Behavioral: BLAST test; The BLAST (Bron/Lyon Attention Stability Test) is a computerized attention test evaluating brief lapses of attention with 4 measures: reaction times, errors and two composite measures (Stability and Intensity). The subjects have to detect the presence or the absence of a specific stimulus during approximatively 60 trials for 3 minutes. Normative data are available for both children and adults. This test is part of the neuropsychological evaluation, conducted the afternoon of the first day of hospitalization. The test is realized at 4:00pm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Salivary a-amylase concentration (U/ml)	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.	3 days following the inclusion

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): April 11, 2022
• Primary Completion (Actual): November 20, 2024
• Study Completion (Actual): November 20, 2024

Study Registration Dates

• First Submitted: December 21, 2021
• First Submitted That Met QC Criteria: December 21, 2021
• First Posted (Actual): January 10, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 20, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: sleep; oxalate; Hypersomnia; Salivary biomarkers; Excessive Diurnal Sleepiness; Children, a-amylase
• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleepiness; Disorders of Excessive Somnolence
• Other Study ID Numbers: 69HCL21_1119; 2021-A02740-41 (Other Identifier: ID-RCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No