Hypersomnia in the Paediatric Population

NCT07766343 | Not Yet Recruiting

• 2 other identifiers: RECHMPL24_01822025-A02188-41
• Study Type: interventional
• Target: 760
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

sleep disorders; sleepiness; pediatric; screening; phenotyping; scales; psychometric measurements; biological collection

Outcome Measures

Primary Outcomes (6)

• Internal consistency of the Epworth Sleepiness Scale for Children and Adolescents (ESEA-E and ESEA-A)

  The ESEA is a self-assessment questionnaire adapted from the Epworth Sleepiness Scale. It evaluates daytime sleepiness in common daily situations. Scores range from 0 to 30. Internal consistency will be assessed using Cronbach's alpha. The analysis will be performed separately for: * ESEA-E (children aged 6-11 years) * ESEA-A (adolescents aged 12-17 years) Each Cronbach's alpha coefficient will be reported independently for each scale version.

  Baseline (V1) for group A and B and during the hospitalization visit at 2 months for group C

• Internal consistency of the Idiopathic Hypersomnia Severity Scale (IHSS) for children and adolescents(IHSS-E and IHSS-A)

  IHSS : A self-administered 14-item questionnaire assessing hypersomnolence, evaluating excessive sleepiness, daytime fatigue, and difficulty maintaining wakefulness, as well as their impact on academic, social, and daily functioning. Internal consistency will be assessed using Cronbach's alpha. The analysis will be performed separately for: IHSS-E (children aged 6-11 years) IHSS-A (adolescents aged 12-17 years). Each Cronbach's alpha coefficient will be reported independently for each scale version.

  Baseline (V1) for group A and B and during the hospitalization visit at 2 months for group C

• Internal consistency of the Pediatric Daytime Sleepiness Scale (PDSS) for children (6-11 years)

  PDSS (6-11) is an 8-item self-administered questionnaire adapted from the PDSS for older children. It measures daytime sleepiness and its impact on daily functioning, especially at school, based on the frequency of fatigue and sleep episodes. Scores range from 0 to 32. Internal consistency will be assessed using Cronbach's alpha.

  Baseline (V1) for group A and B and during the hospitalization visit at 2 months for group C

• Internal consistency of the French Sleepiness Scale for children (FSSC-8)

  FSSC-8 an 8-item self-administered questionnaire adapted from the validated adolescent version (FSSA-8) to assess daytime sleepiness in children. It evaluates the frequency of sleepiness episodes in daily situations. Scores range from 0 to 24.Internal consistency will be assessed using Cronbach's alpha.

  Baseline (V1) for group A and B and during the hospitalization visit at 2 months for group C

• Internal consistency of the Pediatric Hypersomnia Survey (PHS) for children (6-11 years) and adolescents (12-17 years)

  The PHS is a 14-item self-report questionnaire assessing excessive daytime sleepiness in adolescents (12-17), in relation to school and social activities. Scores range from 0 to 42, with a pathological threshold \>24 for narcolepsy/hypersomnia. Internal consistency will be assessed using alpha Cronbach's. The analysis will be performed separately for: PHS (aged 6-11years) and PHS (aged 12-17 years). Each Cronbach's alpha coefficient will be reported independently for each scale version

  Baseline (V1) for group A and B and during the hospitalization visit at 2 months for group C

• Internal consistency of the Short Chronotype Questionnaire (µMunich) for children and adolescents (µMunich-E and µMunich-A)

  A self-administered questionnaire assessing chronotype by recording usual bedtimes and wake-up times on weekdays and days off. It identifies "morning," "evening," or intermediate profiles and helps interpret sleep disorders. Internal consistency will be assessed using Cronbach's alpha. The analysis will be performed separately for: µMunich-E (children aged 6-11 years), µMunich-A(adolescents aged 12-17 years) Each Cronbach's alpha coefficient will be reported independently for each scale version.

  Baseline (V1) for group A and B and during the hospitalization visit at 2 months for group C

Secondary Outcomes (77)

• Correlation coefficients between the Idiopathic Hypersomnia Severity Scale for children and adolescents (IHSS-A and IHSS-E ) and the Pediatric Daytime Sleepiness Scale (PDSS; 12-17years).

  Baseline (V1) for group A and B and during the hospitalization visit at 2 months for group C

• Correlation coefficients between the Idiopatic Hypersomnia Severity Scale (IHSS-A and IHSS-E ) and the Epworth Sleepiness Scale for Children and Adolescents (ESS-CHAD).

  Baseline (V1) and during the hospitalization visit at 2 months

• Correlation coefficients between the Pediatric Hypersomnolence Scale (PHS; 6-11 and 12-17 years) and the Pediatric Daytime Sleepiness Scale (PDSS; 12-17 years)

  Baseline (V1) for group A and B and during the hospitalization visit at 2 months for group C

• Correlation coefficients between the Pediatric Hypersomnolence Scale for children and adolescents (PHS; 6-11 and 12-17 years) and the Epworth Sleepiness Scale for Children and Adolescents (ESS-CHAD)

  Baseline (V1) and during the hospitalization visit at 2 months

• Correlation coefficients between the Epworth Sleepiness Scale (ESEA) for children and adolescents (ESEA-E and ESEA-A) and the Pediatric Daytime Sleepiness Scale (PDSS; 12-17 years)

  Baseline (V1) for group A and B and during the hospitalization visit at 2 months for group C

Study Arms (3)

General population

EXPERIMENTAL

Administration of scales to diagnose a sleep or wakefulness disorder

Other: Sleepness and wakeness scale

Patients with wakeness disorders

ACTIVE COMPARATOR

The control group consisting of patients with wakeness disorders.

Other: Sleepness and wakeness scale; Procedure: Polysomnography; Procedure: Actimetry; Other: Diagnostic scales; Procedure: Ambulatory blood pressure monitoring (ABPM); Other: blood sampling; Other: Urine collection

Healthy volunteers

EXPERIMENTAL

* Completion of screening scales and diagnostic scales * Polysomnography * Actimetry

Other: Sleepness and wakeness scale; Procedure: Polysomnography; Procedure: Actimetry; Other: Diagnostic scales; Procedure: Ambulatory blood pressure monitoring (ABPM); Other: blood sampling; Other: Urine collection

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

General population; Healthy volunteers; Patients with wakeness disorders

Polysomnography PROCEDURE

Polysomnography over 24 hours

Healthy volunteers; Patients with wakeness disorders

Actimetry PROCEDURE

Actimetry over 2 weeks

Healthy volunteers; Patients with wakeness disorders

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

Healthy volunteers; Patients with wakeness disorders

Ambulatory blood pressure monitoring (ABPM) PROCEDURE

Ambulatory blood pressure monitoring (ABPM) over 24 hours

Healthy volunteers; Patients with wakeness disorders

blood sampling OTHER

10 mL of blood are taken

Healthy volunteers; Patients with wakeness disorders

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.

Healthy volunteers; Patients with wakeness disorders

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• For all participants :
• Be aged between 6 and 17 (\< 18 years old).
• Be able to express consent to participate.
• Have at least one legal guardian.
• Speak and understand French.
• Obtain consent from the person(s) with parental authority (or from one parent if the patient is accompanied by only one parent, in accordance with Article 1122-2 of the Public Health Code) or from the child's legal guardian.
• Be affiliated with a Social Security scheme or be covered by such a scheme
• For patients with CHD :
• \- Patients with a clinical diagnosis of NT1 according to international criteria (32) with symptom onset (sleepiness and/or cataplexy) dating back no more than two years. The ICSD-3-TR criteria are: SDE lasting at least 3 months, and the presence of one or two of the following:
• Well-defined cataplexy, with either:
• Mean sleep latency of 8 minutes or less on TILEs, and at least 2 episodes of REM sleep onset polysomnography (SOREMP), Or
• One episode of SOREMP within 15 minutes of falling asleep during the night of recording.
• A hypocretin level in the CSF of less than or equal to 110 pg/mL. OR
• Patients with a clinical diagnosis of NT2 according to international criteria (30) with onset of sleepiness dating back no more than two years. The ICSD-3 criteria are: SDE evolving for at least 3 years, absence of cataplexy and average sleep latency less than or equal to 8 minutes on TILEs, and at least 2 SOREMPs (one SOREMP the previous night can replace one SOREMP on the TILE). The hypocretin level in the CSF must be greater than 110 pg/mL. In addition, the symptoms and TILE results must not be better explained by other causes (e.g., sleep deprivation, CRD, OSA).
• Patients with a clinical diagnosis of IH according to the ICSD-3-TR international criteria, which are as follows: EDS occurring daily for at least 3 months, absence of cataplexy, PSG and MSLT results must not be compatible with narcolepsy (NT1 or NT2): there must be fewer than 2 SOREMPs in total on MSLTs or no SOREMPs if the REM sleep latency on PSG was ≤15 minutes. Also, the presence of at least one of the following two criteria:

You may not qualify if:

• Retrait du consentement.
• Souhait du mineur d'interrompre l'étude.
• Maladie ou condition intercurrente qui interfère avec la poursuite de la participation du sujet à l'étude.
• Lors de la visite 2 : si traitement médicamenteux qui agit sur la somnolence ou la vigilance, ou qui n'a pas été stoppé suffisamment tôt.
• Décision de l'investigateur.

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• Société Française de Recherche et de Médecine du Sommeil: collaborator

Study Sites (1)

CHU de Montpellier - Hôpital Gui de Chauliac

Montpellier, Hérault, 34295, France

Location

MeSH Terms

Conditions

Narcolepsy; Idiopathic Hypersomnia; Sleep Wake Disorders; Sleepiness

Interventions

Blood Specimen Collection; Urine Specimen Collection

Condition Hierarchy (Ancestors)

Disorders of Excessive Somnolence; Sleep Disorders, Intrinsic; Dyssomnias; Nervous System Diseases; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Lucie BARATEAU, Dr

CONTACT

+33 04 67 33 31 65; l-barateau@chu-montpellier.fr

Study Design

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

Study Record Dates

• First Submitted: February 10, 2026
• First Posted: August 14, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): November 1, 2029
• Last Updated: August 14, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)