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Amylase and Hypersomnia (Amylase)

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ClinicalTrials.gov Identifier: NCT01926405
Recruitment Status : Completed
First Posted : August 20, 2013
Last Update Posted : February 14, 2018
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

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.


Condition or disease Intervention/treatment Phase
Hypersomnia in Children Procedure: saliva collection Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Evaluation of Excessive Diurnal Sleepiness by the Expression and Activity of Salivary Amylase in Children With Hypersomnia.
Actual Study Start Date : January 2013
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Subjects with narcolepsy or with idiopathic hypersomnia Procedure: saliva collection
collection of saliva

Control patients with no sleeping disorder Procedure: saliva collection
collection of saliva




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Measurement of the mean sleep onset latency using the Multiple Sleep Latency Test (MSLT) [ Time Frame: 3 days ]
    To highlight a correlation between the degree of somnolence measured by MSLT and the rate of salivary amylase.

  2. Measurement of the somnolence using Epworth and Karolinska scales [ Time Frame: 3 days ]
    To highlight a correlation between the degree of somnolence measured by the scales and the rate of salivary amylase.



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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01926405


Locations
France
Hôpital Femme-Mère-Enfant, Exploration et pathologie du sommeil
Bron, France, 69677
Sponsors and Collaborators
Hospices Civils de Lyon

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT01926405     History of Changes
Other Study ID Numbers: 2011.681
First Posted: August 20, 2013    Key Record Dates
Last Update Posted: February 14, 2018
Last Verified: February 2018

Keywords provided by Hospices Civils de Lyon:
hypersomnia
narcolepsy
amylase
salivary sampling

Additional relevant MeSH terms:
Disorders of Excessive Somnolence
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders