Hypersomnia in ChildrenAmylaseNCT01926405
Amylase and Hypersomnia
A study testing saliva collection in people with Hypersomnia in Children, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Hypersomnia is defined as a reduced ability to remain awake during the day. There are basically two types of central hypersomnia: narcolepsy and idiopathic hypersomnia. Currently, the diagnosis of these sleep disorders is based on polysomnographic recordings which is difficult to access. Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypersomnia in Children
- What is being tested?
- saliva collection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2013to Sep 2016
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Subjects with hypersomnia (narcolepsy or idiopathic):
- Children and adolescents with hypersomnia (according to ICSD diagnostic criteria 2); narcolepsy or idiopathic hypersomnia (with or without lengthening of sleep),
- aged > 6 years and <18 years,
- no treatment,
- Parent consent
- Control subjects:
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- healthy children and adolescents without any known pathology,
- aged > 6 years and <18 years,
- matched on sex and age> 6 years - <12 years,> 12 - <18 years)
- Parent Consent
Who cannot join
- Subjects with hypersomnia (narcolepsy or idiopathic):
- Secondary narcolepsy,
- Symptomatic hypersomnia,
- Restless legs syndrome,
- Sleep apnea syndrome,
- Severe neurological, psychiatric, cognitive or endocrinological concomitant disease.
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- Control subjects:
- Hypersomnia,
- Restless legs syndrome,
- Sleep apnea syndrome,
- Severe neurological, psychiatric, cognitive or endocrinological concomitant disease,
- Sleep disorder evaluated by a score > 70 on the Sleep Disturbance Scale for Children19,
- Excessive daytime sleepiness according to Epworth scales (score > 10),
- Abnormal sleep time according to the age (sleep diary).
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital Femme-Mère-Enfant, Exploration et pathologie du sommeil
Bron, 69677
About this study
Official title: Evaluation of Excessive Diurnal Sleepiness by the Expression and Activity of Salivary Amylase in Children With Hypersomnia.
Hypersomnia is defined as a reduced ability to remain awake during the day. There are basically two types of central hypersomnia: narcolepsy and idiopathic hypersomnia. Currently, the diagnosis of these sleep disorders is based on polysomnographic recordings which is difficult to access. Tests of sleepiness (Epworth, Karolinska) are subjective.
A biological marker of sleepiness, easily accessible and measurable, would be very useful for the diagnosis and therapeutic follow up of excessive diurnal sleepiness. Salivary secretions appear as good physiological markers. Studies have shown for healthy subjects, that the expression and activity of salivary amylase are increased when subjects are deprived of sleep.
The investigators propose to explore the usefulness of salivary biomarkers (including amylase) as a new non-invasive and simple technique for the assessment of excessive daytime sleepiness.
- Conditions
- Hypersomnia in Children
- Being tested
- saliva collection
- Keywords
- hypersomnia, narcolepsy, amylase, salivary sampling
- Medical subject headings
- Disorders of Excessive Somnolence, Narcolepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
saliva collectionProcedure or surgery
collection of saliva
| Study group | Role | What they receive |
|---|---|---|
| Subjects with narcolepsy or with idiopathic hypersomnia | Other | Not described Receives: Procedure: saliva collection |
| Control patients with no sleeping disorder | Other | Not described Receives: Procedure: saliva collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of the expression and enzymatic activity of salivary amylase.
Show an increase of salivary amylase for children with hypersomnia or narcolepsy compared to a group of children matched on age and sex.
Measured: 3 days
Secondary outcomes (2)
Measurement of the mean sleep onset latency using the Multiple Sleep Latency Test (MSLT)
To highlight a correlation between the degree of somnolence measured by MSLT and the rate of salivary amylase.
Measured: 3 days
Measurement of the somnolence using Epworth and Karolinska scales
To highlight a correlation between the degree of somnolence measured by the scales and the rate of salivary amylase.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2013 (estimated)
- Study startJan 2013
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypersomnia in ChildrenStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 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
- NCT01926405
- Sponsor's protocol ID
- 2011.681
- Acronym
- Amylase
- Status last verified
- Feb 2018
- First submitted
- 12 Aug 2013
- Last updated
- 14 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Excessive Diurnal Sleepiness by the Expression and Activity of Salivary Amylase in Children With Hypersomnia.
- ClinicalTrials.gov ID
- NCT01926405
- Acronym / sponsor ID
- Amylase / 2011.681
- Conditions
- Hypersomnia in Children
- Keywords
- hypersomnia, narcolepsy, amylase, salivary sampling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Jan 2013 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 20 Aug 2013 (estimated)
- 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.
Hypersomnia is defined as a reduced ability to remain awake during the day. There are basically two types of central hypersomnia: narcolepsy and idiopathic hypersomnia. Currently, the diagnosis of these sleep disorders is based on polysomnographic recordings which is difficult to access. Tests of sleepiness (Epworth, Karolinska) are subjective.
A biological marker of sleepiness, easily accessible and measurable, would be very useful for the diagnosis and therapeutic follow up of excessive diurnal sleepiness. Salivary secretions appear as good physiological markers. Studies have shown for healthy subjects, that the expression and activity of salivary amylase are increased when subjects are deprived of sleep.
The investigators propose to explore the usefulness of salivary biomarkers (including amylase) as a new non-invasive and simple technique for the assessment of excessive daytime sleepiness.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subjects with narcolepsy or with idiopathic hypersomnia | Other | Procedure: saliva collection |
| Control patients with no sleeping disorder | Other | Procedure: saliva collection |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- Children and adolescents with hypersomnia (according to ICSD diagnostic criteria 2); narcolepsy or idiopathic hypersomnia (with or without lengthening of sleep),
- aged > 6 years and <18 years,
- no treatment,
- Parent consent
- healthy children and adolescents without any known pathology,
Key exclusion criteria (14 listed)
- Subjects with hypersomnia (narcolepsy or idiopathic):
- Secondary narcolepsy,
- Symptomatic hypersomnia,
- Restless legs syndrome,
- Sleep apnea syndrome,
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 collectioncollection of saliva | Procedure or surgery | Control patients with no sleeping disorder, Subjects with narcolepsy or with idiopathic hypersomnia |
Primary outcome
Determination of the expression and enzymatic activity of salivary amylase.
Time frame: 3 days
Show an increase of salivary amylase for children with hypersomnia or narcolepsy compared to a group of children matched on age and sex.
2 secondary outcomes
Measurement of the mean sleep onset latency using the Multiple Sleep Latency Test (MSLT)
Time frame: 3 days
Measurement of the somnolence using Epworth and Karolinska scales
Time frame: 3 days
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 14 Feb 2018.
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?
A study testing saliva collection in people with Hypersomnia in Children, 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 10 inclusion and 14 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 14 Feb 2018. 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?
Determination of the expression and enzymatic activity of salivary amylase. (time frame: 3 days). 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 14 Feb 2018.