Hypersomnia in the Paediatric Population (NCT07766343) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Hypersomnia in the Paediatric Population
France760 participantsStarted 2026-09
Plain-language 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.
Who can participate
Age range
6 Years – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Well-defined cataplexy, with either:
. A hypocretin level in the CSF of less than or equal to 110 pg/mL. OR
. Mean sleep latency (TILE) ≤ 8 minutes,
. Total sleep time over 24 hours ≥ 12 hours (or over 32 hours ≥ 19 hours) or measured by continuous 24-hour PSG after ensuring that the patient is not sleep deprived (by actigraphy + sleep diary over at least 7 days of unrestricted sleep).
. the symptoms of RLS and TILE results must not be better explained by another sleep disorder, medical disorder, psychiatric disorder, or the use of sedative substances or medications.
Patients diagnosed with circadian rhythm sleep disorder (CRD) according to ICSD-3-TR, followed up in secondary/tertiary care, with symptoms present for ≥3 months. ICSD-3-TR criteria: Sleeping and waking times consistently delayed by ≥2 hours relative to social schedules (e.g., late bedtime with late wake-up time).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Internal consistency of the Epworth Sleepiness Scale for Children and Adolescents (ESEA-E and ESEA-A)
Timeframe: Baseline (V1) for group A and B and during the hospitalization visit at 2 months for group C
2
Internal consistency of the Idiopathic Hypersomnia Severity Scale (IHSS) for children and adolescents(IHSS-E and IHSS-A)
Timeframe: Baseline (V1) for group A and B and during the hospitalization visit at 2 months for group C
3
Internal consistency of the Pediatric Daytime Sleepiness Scale (PDSS) for children (6-11 years)
Timeframe: Baseline (V1) for group A and B and during the hospitalization visit at 2 months for group C
4
Internal consistency of the French Sleepiness Scale for children (FSSC-8)
Timeframe: Baseline (V1) for group A and B and during the hospitalization visit at 2 months for group C
5
Internal consistency of the Pediatric Hypersomnia Survey (PHS) for children (6-11 years) and adolescents (12-17 years)
Timeframe: Baseline (V1) for group A and B and during the hospitalization visit at 2 months for group C
6
Internal consistency of the Short Chronotype Questionnaire (µMunich) for children and adolescents (µMunich-E and µMunich-A)
Children/adolescents with obesity, defined as a body mass index (BMI) above the 97th percentile for age and gender, according to reference curves. The diagnosis is made by an experienced clinician based on standardized anthropometric measurements (weight, height, BMI calculation). They may present with associated sleep disorders (fragmentation, snoring, EDS), as determined by actimetry, polysomnography, or standardized questionnaires.
Exclusion criteria
Retrait du consentement.
Timeframe: Baseline (V1) for group A and B and during the hospitalization visit at 2 months for group C