HypersomniaBIOSOMNCT05183464
Analysis of New Salivary Biomarkers to Evaluate Excessive Diurnal Sleepiness in Children With Hypersomnia
An observational study of Hypersomnia and Sleepiness, Excessive Daytime, run by Hospices Civils de Lyon at 1 site in France.
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). Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Hypersomnia, Sleepiness, Excessive Daytime
- What is being tested?
- saliva samples, Stanford sleepiness scale and Karolinska Sleepiness Scale
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 116 participants
- Where
- 1 siteFrance
- Study dates
- 11 Apr 2022to 20 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children hospitalized for an evaluation of their excessive diurnal sleepiness will be included in this study.
Who may be able to join
- 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
Who cannot join
- Opposition of the child or parents to participate
- Patients under measure of deprivation of rights and liberty
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital Mère-Enfant - Service d'épileptologie clinique, des troubles du sommeil et de neurologie fonctionnelle de l'enfant
Bron, 69677
About this study
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.
Read more
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.
- Conditions
- Hypersomnia, Sleepiness, Excessive Daytime
- Being tested
- saliva samples, Stanford sleepiness scale, Karolinska Sleepiness Scale, Epworth Sleepiness Scale, BLAST test
- Keywords
- Excessive Diurnal Sleepiness, Salivary biomarkers, Children, a-amylase, oxalate, Hypersomnia, sleep
- Medical subject headings
- Disorders of Excessive Somnolence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
saliva samplesBiological
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.
Stanford sleepiness scaleBehavioural
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 ScaleBehavioural
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 ScaleBehavioural
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 testBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Children with primary hypersomnia | Children with primary hypersomnia, i.e. narcolepsy or idiopathic hypersomnia Receives: Biological: saliva samples; Behavioral: Stanford sleepiness scale; Behavioral: Karolinska Sleepiness Scale; Behavioral: Epworth Sleepiness Scale; Behavioral: BLAST test | |
| Children with secondary hypersomnia | Children with a secondary hypersomnia, i.e. caused by sleep deprivation, a psychiatric disorder, sleep fragmentation, circadian delay. Receives: Biological: saliva samples; Behavioral: Stanford sleepiness scale; Behavioral: Karolinska Sleepiness Scale; Behavioral: Epworth Sleepiness Scale; Behavioral: BLAST test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 days following the inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2022
- Study start11 Apr 2022
- Primary completion20 Nov 2024
- Study completion20 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypersomniaStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05183464
- Sponsor's protocol ID
- 69HCL21_1119
- Other IDs
- 2021-A02740-41
- Acronym
- BIOSOM
- Status last verified
- Feb 2025
- First submitted
- 21 Dec 2021
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of New Salivary Biomarkers to Evaluate Excessive Diurnal Sleepiness in Children With Hypersomnia
- ClinicalTrials.gov ID
- NCT05183464
- Acronym / sponsor ID
- BIOSOM / 69HCL21_1119
- Conditions
- Hypersomnia, Sleepiness, Excessive Daytime
- Keywords
- Excessive Diurnal Sleepiness, Salivary biomarkers, Children, a-amylase, oxalate, Hypersomnia, sleep
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 11 Apr 2022 (actual)
- Primary completion
- 20 Nov 2024 (actual)
- Study completion
- 20 Nov 2024 (actual)
- First posted
- 10 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children with primary hypersomnia | – | Biological: saliva samples, Behavioral: Stanford sleepiness scale, Behavioral: Karolinska Sleepiness Scale, Behavioral: Epworth Sleepiness Scale, Behavioral: BLAST testChildren with primary hypersomnia, i.e. narcolepsy or idiopathic hypersomnia |
| Children with secondary hypersomnia | – | Biological: saliva samples, Behavioral: Stanford sleepiness scale, Behavioral: Karolinska Sleepiness Scale, Behavioral: Epworth Sleepiness Scale, Behavioral: BLAST testChildren with a secondary hypersomnia, i.e. caused by sleep deprivation, a psychiatric disorder, sleep fragmentation, circadian delay. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children hospitalized for an evaluation of their excessive diurnal sleepiness will be included in this study.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Opposition of the child or parents to participate
- Patients under measure of deprivation of rights and liberty
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| saliva samplesCollection 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. | Biological | Children with primary hypersomnia, Children with secondary hypersomnia |
| Stanford sleepiness scaleThe 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) | Behavioural | Children with primary hypersomnia, Children with secondary hypersomnia |
| Karolinska Sleepiness ScaleThe 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) | Behavioural | Children with primary hypersomnia, Children with secondary hypersomnia |
| Epworth Sleepiness ScaleThe 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. | Behavioural | Children with primary hypersomnia, Children with secondary hypersomnia |
| BLAST testThe 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. | Behavioural | Children with primary hypersomnia, Children with secondary hypersomnia |
Primary outcome
Salivary a-amylase concentration (U/ml)
Time frame: 3 days following the inclusion
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypersomnia and Sleepiness, Excessive Daytime, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Salivary a-amylase concentration (U/ml) (time frame: 3 days following the inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2025.