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

Hypersomnia Clinical Trial

— BIOSOM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05183464
• Other study ID #: 69HCL21_1119
• Secondary ID: 2021-A02740-41
• Status: Recruiting
• Start date: April 11, 2022
• Est. completion date: April 11, 2025

Study information

• Verified date: April 2022
• Source: Hospices Civils de Lyon
• Contact: Patricia FRANCO, PU,PH
• Phone: 04.27.85.60.52
• Email: patricia.franco[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 98
• Est. completion date: April 11, 2025
• Est. primary completion date: April 11, 2025
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Disorders of Excessive Somnolence
• Hypersomnia
• Sleepiness

Intervention

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)
• 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)
• 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.
• 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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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