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

CompletedOBSERVATIONAL
Enrollment

116

Participants

Timeline

Start Date

April 11, 2022

Primary Completion Date

November 20, 2024

Study Completion Date

November 20, 2024

Conditions
HypersomniaSleepiness, Excessive Daytime
Interventions
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."

Trial Locations (1)

69677

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

All Listed Sponsors
lead

Hospices Civils de Lyon

OTHER