Analysis of New Salivary Biomarkers to Evaluate Excessive Diurnal Sleepiness in Children With Hypersomnia
BIOSOM
2 other identifiers
observational
116
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2022
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 21, 2021
CompletedFirst Posted
Study publicly available on registry
January 10, 2022
CompletedStudy Start
First participant enrolled
April 11, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 20, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
November 20, 2024
CompletedFebruary 24, 2025
February 1, 2025
2.6 years
December 21, 2021
February 20, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Children with primary hypersomnia
Children with primary hypersomnia, i.e. narcolepsy or idiopathic hypersomnia
Children with secondary hypersomnia
Children with a secondary hypersomnia, i.e. caused by sleep deprivation, a psychiatric disorder, sleep fragmentation, circadian delay.
Interventions
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.
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)
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)
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.
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.
Eligibility Criteria
Children hospitalized for an evaluation of their excessive diurnal sleepiness will be included in this study.
You may qualify if:
- 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
You may not qualify if:
- Opposition of the child or parents to participate
- Patients under measure of deprivation of rights and liberty
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hôpital Mère-Enfant - Service d'épileptologie clinique, des troubles du sommeil et de neurologie fonctionnelle de l'enfant
Bron, 69677, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 21, 2021
First Posted
January 10, 2022
Study Start
April 11, 2022
Primary Completion
November 20, 2024
Study Completion
November 20, 2024
Last Updated
February 24, 2025
Record last verified: 2025-02