Amylase and Hypersomnia

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01926405
• Date of registration: 12/08/2013
• Prospective Registration: No
• Primary sponsor: Hospices Civils de Lyon
• Public title: Amylase and Hypersomnia Amylase
• Scientific title: Evaluation of Excessive Diurnal Sleepiness by the Expression and Activity of Salivary Amylase in Children With Hypersomnia.
• Date of first enrolment: January 2013
• Target sample size: 54
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01926405
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

France

Key inclusion & exclusion 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).



Age minimum: 6 Years
Age maximum: 18 Years
Gender: All

Health Condition(s) or Problem(s) studied

Hypersomnia in Children

Intervention(s)

Procedure: saliva collection

Primary Outcome(s)

Determination of the expression and enzymatic activity of salivary amylase. [Time Frame: 3 days]

Secondary Outcome(s)

Measurement of the mean sleep onset latency using the Multiple Sleep Latency Test (MSLT) [Time Frame: 3 days]

Measurement of the somnolence using Epworth and Karolinska scales [Time Frame: 3 days]

Secondary ID(s)

2011.681

Source(s) of Monetary Support

Please refer to primary and secondary sponsors