Amylase and Hypersomnia

This study is currently recruiting participants.
Verified August 2013 by Hospices Civils de Lyon
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT01926405
First received: August 12, 2013
Last updated: August 19, 2013
Last verified: August 2013
  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: 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   6 Years to 18 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT01926405     History of Changes
Other Study ID Numbers: 2011.681
Study First Received: August 12, 2013
Last Updated: August 19, 2013
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

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 Disorders
Nervous System Diseases
Mental Disorders

ClinicalTrials.gov processed this record on April 17, 2014