Hypersomnia in the Paediatric Population

Sponsor
University Hospital, Montpellier
Study ID
NCT07766343
Status
Not Yet Recruiting

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Conditions

  • Idiopathic Hypersomnia
  • Narcolepsy
  • Wakefulness Disorder

Eligibility Criteria

Sex
ALL
Age
6 Years - 17 Years
Healthy Volunteers
Accepted

Interventions

  • Sleepness and wakeness scale — OTHER
    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
  • Polysomnography — PROCEDURE
    Polysomnography over 24 hours
  • Actimetry — PROCEDURE
    Actimetry over 2 weeks
  • Diagnostic scales — OTHER
    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
  • Ambulatory blood pressure monitoring (ABPM) — PROCEDURE
    Ambulatory blood pressure monitoring (ABPM) over 24 hours
  • blood sampling — OTHER
    10 mL of blood are taken
  • Urine collection — OTHER
    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.

Study Details

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.

Key Dates

First listed
Aug 14, 2026
Start date
Sep 30, 2026
Status verified
Aug 2026
Primary completion
May 31, 2029
Completion
Nov 30, 2029

Study Design

Enrollment
760 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: General population
    Administration of scales to diagnose a sleep or wakefulness disorder
  • Active Comparator: Patients with wakeness disorders
    The control group consisting of patients with wakeness disorders.
  • Experimental: Healthy volunteers
    * Completion of screening scales and diagnostic scales * Polysomnography * Actimetry

Primary Outcome Measure

Internal consistency of the Epworth Sleepiness Scale for Children and Adolescents (ESEA-E and ESEA-A) [ Time Frame: Baseline (V1) for group A and B and during the hospitalization visit at 2 months for group C ]

Central Contacts

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