NCT01926405

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 12, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 20, 2013

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

February 14, 2018

Status Verified

February 1, 2018

Enrollment Period

3.7 years

First QC Date

August 12, 2013

Last Update Submit

February 12, 2018

Conditions

Hypersomnia in Children

Keywords

hypersomnianarcolepsyamylasesalivary sampling

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 days

Secondary Outcomes (2)

  • Measurement of the mean sleep onset latency using the Multiple Sleep Latency Test (MSLT)

    3 days

  • Measurement of the somnolence using Epworth and Karolinska scales

    3 days

Study Arms (2)

Subjects with narcolepsy or with idiopathic hypersomnia

OTHER
Procedure: saliva collection

Control patients with no sleeping disorder

OTHER
Procedure: saliva collection

Interventions

saliva collectionPROCEDURE

collection of saliva

Control patients with no sleeping disorderSubjects with narcolepsy or with idiopathic hypersomnia

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Bron, 69677, France

Location

MeSH Terms

Conditions

Disorders of Excessive SomnolenceNarcolepsy

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2013

First Posted

August 20, 2013

Study Start

January 1, 2013

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

February 14, 2018

Record last verified: 2018-02

Locations

FR(1)