Hypersomnia in the Paediatric Population

Summary

This is a 36-month, multicentric, cross-sectional study involving a paediatric population aged 6 to 17 years. Three groups will be included:

Group A: children from the general population with no complaints of sleepiness; Group B: children with a sleep disorder or excessive sleepiness associated with a medical condition (narcolepsy, circadian rhythm sleep disorder (CRSD), non-REM parasomnias, attention deficit disorder with or without hyperactivity (ADHD), autism spectrum disorder (ASD) or obesity); Group C: healthy volunteers with no medical conditions or sleep-related complaints.

Conditions

• Wakefulness Disorder
• Narcolepsy
• Idiopathic Hypersomnia

Interventions

OTHER

Sleepness and wakeness scale

Pediatric Hypersomnia Survey (PHS) Pediatric Daytime Sleepiness Scale (PDSS) Somnolence Scale Adapted for Children and Adolescents French Sleepiness Scale for Children Idiopathic Hypersomnia Severity Scale µMunich Short Chronotype Questionnaire

PROCEDURE

Polysomnography

Polysomnography over 24 hours

PROCEDURE

Actimetry

Actimetry over 2 weeks

OTHER

Diagnostic scales

Pediatric Narcolepsy Severity Scale Insomnia Severity Index Children's Depression Inventory Epworth Sleepiness Scale for Children and Adolescents Life Experiences and Perceived Health among Adolescents Pure Procrastination Scale Sleep Disturbance Scale for Children

PROCEDURE

Ambulatory blood pressure monitoring (ABPM)

Ambulatory blood pressure monitoring (ABPM) over 24 hours

OTHER

blood sampling

10 mL of blood are taken

OTHER

Urine collection

Urine collection during polysomnography, collection periods are: 2:00 p.m. to 5:00 p.m., 5:00 p.m. to 8:00 p.m., 8:00 p.m. to 8:00 a.m., 8:00 a.m. to 11:00 a.m., 11:00 a.m. to 2:00 p.m.

Sponsors & Collaborators

• Société Française de Recherche et de Médecine du Sommeil

  collaborator OTHER

• University Hospital, Montpellier

  lead OTHER

Study Design

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

6 Years

Max Age

17 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-09-30

Primary Completion

2029-05-31

Completion

2029-11-30

Countries

• France

Study Locations