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Amylase and Hypersomnia (Amylase)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2014 by Hospices Civils de Lyon.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01926405
First Posted: August 20, 2013
Last Update Posted: June 27, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hospices Civils de Lyon
  Purpose

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 Intervention
Hypersomnia in Children Procedure: saliva collection

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Evaluation of Excessive Diurnal Sleepiness by the Expression and Activity of Salivary Amylase in Children With Hypersomnia.

Resource links provided by NLM:


Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:
  • 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:
  • 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.

  • 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.


Estimated Enrollment: 80
Study Start Date: January 2013
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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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).
  Contacts and Locations
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


Contacts
Contact: Sonia Galletti, CRA 04 27 85 77 39 ext +33 sonia.galletti@chu-lyon.fr
Contact: Segolene Gaillard, CRA 04 27 85 77 39 ext +33 segolene.gaillard@chu-lyon.fr

Locations
France
Hôpital Femme-Mère-Enfant, Exploration et pathologie du sommeil Recruiting
Bron, France, 69677
Contact: Patricia Franco, MD    : 04 27 85 60 52 ext +33    patricia.franco@chu-lyon.fr   
Principal Investigator: Patricia Franco, MD         
Sponsors and Collaborators
Hospices Civils de Lyon
  More Information

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT01926405     History of Changes
Other Study ID Numbers: 2011.681
First Submitted: August 12, 2013
First Posted: August 20, 2013
Last Update Posted: June 27, 2014
Last Verified: June 2014

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