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Amylase and Hypersomnia (Amylase)

Primary Purpose

Hypersomnia in Children

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
saliva collection
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hypersomnia in Children focused on measuring hypersomnia, narcolepsy, amylase, salivary sampling

Eligibility Criteria

6 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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:

  • 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

Exclusion Criteria:

  • Subjects with hypersomnia (narcolepsy or idiopathic):
  • Secondary narcolepsy,
  • Symptomatic hypersomnia,
  • Restless legs syndrome,
  • Sleep apnea syndrome,
  • Severe neurological, psychiatric, cognitive or endocrinological concomitant disease.

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).

Sites / Locations

  • Hôpital Femme-Mère-Enfant, Exploration et pathologie du sommeil

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Subjects with narcolepsy or with idiopathic hypersomnia

Control patients with no sleeping disorder

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
August 12, 2013
Last Updated
February 12, 2018
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT01926405
Brief Title
Amylase and Hypersomnia
Acronym
Amylase
Official Title
Evaluation of Excessive Diurnal Sleepiness by the Expression and Activity of Salivary Amylase in Children With Hypersomnia.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
January 2013 (Actual)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypersomnia in Children
Keywords
hypersomnia, narcolepsy, amylase, salivary sampling

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Subjects with narcolepsy or with idiopathic hypersomnia
Arm Type
Other
Arm Title
Control patients with no sleeping disorder
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
saliva collection
Intervention Description
collection of saliva
Primary Outcome Measure Information:
Title
Determination of the expression and enzymatic activity of salivary amylase.
Description
Show an increase of salivary amylase for children with hypersomnia or narcolepsy compared to a group of children matched on age and sex.
Time Frame
3 days
Secondary Outcome Measure Information:
Title
Measurement of the mean sleep onset latency using the Multiple Sleep Latency Test (MSLT)
Description
To highlight a correlation between the degree of somnolence measured by MSLT and the rate of salivary amylase.
Time Frame
3 days
Title
Measurement of the somnolence using Epworth and Karolinska scales
Description
To highlight a correlation between the degree of somnolence measured by the scales and the rate of salivary amylase.
Time Frame
3 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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: 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 Exclusion Criteria: Subjects with hypersomnia (narcolepsy or idiopathic): Secondary narcolepsy, Symptomatic hypersomnia, Restless legs syndrome, Sleep apnea syndrome, Severe neurological, psychiatric, cognitive or endocrinological concomitant disease. 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).
Facility Information:
Facility Name
Hôpital Femme-Mère-Enfant, Exploration et pathologie du sommeil
City
Bron
ZIP/Postal Code
69677
Country
France

12. IPD Sharing Statement

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Amylase and Hypersomnia

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