Amylase and Hypersomnia (Amylase)

February 12, 2018 updated by: Hospices Civils de Lyon

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bron, France, 69677
        • Hôpital Femme-Mère-Enfant, Exploration et pathologie du sommeil

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Subjects with narcolepsy or with idiopathic hypersomnia
Procedure: saliva collection
collection of saliva
Other: Control patients with no sleeping disorder
Procedure: saliva collection
collection of saliva

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 days
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.
3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2013

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

August 12, 2013

First Submitted That Met QC Criteria

August 19, 2013

First Posted (Estimate)

August 20, 2013

Study Record Updates

Last Update Posted (Actual)

February 14, 2018

Last Update Submitted That Met QC Criteria

February 12, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011.681

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hypersomnia in Children

Clinical Trials on saliva collection

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Congo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe