An interventional study of Sleepness and wakeness scale and Polysomnography in Wakefulness Disorder, Narcolepsy and Idiopathic Hypersomnia, sponsored by University Hospital, Montpellier. Not yet recruiting at 1 site in France. Open to participants aged 6 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-14.
Sponsored by University Hospital, Montpellier · Not applicable, Interventional, and Diagnostic
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.
"This is a prospective diagnostic study where participants are assigned to a standardized evaluation protocol. The study procedures-including experimental unvalidated sleepiness questionnaires, mandatory 24-hour continuous Video-Polysomnography (PSG), Multiple Sleep Latency Tests (MSLT/TILE), actigraphy, and biological sampling-are explicitly assigned by the study protocol and are performed outside the scope of routine clinical care.
157 studies on the registry are indexed under Narcolepsy; 37 are open to participants now.
This study's planned enrollment of 760 is above the median of 78 across 114 interventional studies indexed under Narcolepsy.
Browse Narcolepsy studies →University Hospital, Montpellier is the lead sponsor of 1,261 studies on the registry; 224 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
A hypocretin level in the CSF of less than or equal to 110 pg/mL. OR
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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.
For patients with CRD :
-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).
- Symptoms have been present for at least three months.
- When patients are allowed to choose their schedule ad libitum, they show an improvement in sleep quality and duration for their age and maintain a delayed phase of the 24-hour sleep-wake pattern.
For patients with OSA :
- Patients diagnosed with OSA according to ICSD-3-TR, based on polysomnography at a university hospital or specialized center, with at least:
For patients with Non REM parasomnia :
- Children/adolescents diagnosed according to ICSD-3-TR with NREM parasomnias (sleepwalking or night terrors):
- Recurrent episodes (≥2 in 6 months) typically occurring during N3 sleep, with no memory or dream content,
- Confusion/reduced responsiveness during the episode,
- Possible confirmation by video PSG or parental history combined with a sleep diary.
For patients with ASD :
- Patients diagnosed with ASD according to , confirmed by a multidisciplinary assessment (ADI-R, ADOS-2, ENT-AM) and monitored by a specialized team. Patients must present with phase delay, prolonged insomnia, or severe sleep fragmentation (WASO > 60 min, latency > 30 min) as confirmed by actimetry.
For patients with ADHD :
- Children/adolescents diagnosed with ADHD according to DSM-5, made by an experienced clinician and confirmed by standardized scales (Conners, ADHD-RS). Must present with sleep disturbances (difficulty falling asleep, WASO > 30 min, phase delays, etc.), assessed by actimetry or sleep diary, with symptoms established for ≥ 6 months.
For patients with obesity :
-Children/adolescents with obesity, defined as a (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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Administration of scales to diagnose a sleep or wakefulness disorder
Other: Sleepness and wakeness scale
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
* 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
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 over 24 hours
Actimetry over 2 weeks
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) over 24 hours
10 mL of blood are taken
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: Baseline (V1) for group A and B and during the hospitalization visit at 2 months for group C
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).
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. Versions for children (6-11 years, IHSS-E) and adolescents (12-17 years, IHSS-A) are being validated PDSS 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
Time frame: 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).
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. Versions for children (6-11 years, IHSS-E) and adolescents (12-17 years, IHSS-A) are being validated. ESS-CHAD : an 8-item questionnaire designed to assess daytime sleepiness. Participants assign a score from 0 to 3 (0 = never; 1 = weak; 2 = moderate; 3 = strong).The minimum score is 0 and the maximum score is 24.
Time frame: 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)
PDSS 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. 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. A French version for children aged 6-11 (PHS 6-11) is awaiting validation.
Time frame: 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)
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. A French version for children aged 6-11 (PHS 6-11) is awaiting validation. ESS-CHAD : an 8-item questionnaire designed to assess daytime sleepiness. Participants assign a score from 0 to 3 (0 = never; 1 = weak; 2 = moderate; 3 = strong).The minimum score is 0 and the maximum score is 24.
Time frame: 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)
ESEA-A is a self-assessment questionnaire adapted from the Epworth Sleepiness Scale for adolescents (12-17 years). It evaluates daytime sleepiness in common daily situations. Scores range from 0 to 30, with the pathological threshold to be validated. A simplified version for children (6-11 years, ESEA-E) is also under validation. PDSS 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.
Time frame: Baseline (V1) for group A and B and during the hospitalization visit at 2 months for group C
Correlation coefficients between the Epworth Sleepiness Scale for children and adolescents (ESEA-E and ESEA-A) and the Epworth Sleepiness Scale for Children and Adolescents (ESS-CHAD)
ESEA-A is a self-assessment questionnaire adapted from the Epworth Sleepiness Scale for adolescents (12-17 years). It evaluates daytime sleepiness in common daily situations. Scores range from 0 to 30, with the pathological threshold to be validated. A simplified version for children (6-11 years, ESEA-E) is also under validation. ESS-CHAD : an 8-item questionnaire designed to assess daytime sleepiness. Participants assign a score from 0 to 3 (0 = never; 1 = weak; 2 = moderate; 3 = strong).The minimum score is 0 and the maximum score is 24.
Time frame: Baseline (V1) and during the hospitalization visit at 2 months
Correlation coefficients between the French Sleepiness Scale for children (FSSC-8) and the Pediatric Daytime Sleepiness Scale (PDSS; 12-17 years)
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. PDSS 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.
Time frame: Baseline (V1) for group A and B and during the hospitalization visit at 2 months for group C
Correlation coefficients between the Pediatric Daytime Sleepiness Scale (PDSS; 6-11 years) and the Pediatric Daytime Sleepiness Scale (PDSS; 12-17 years)
PDSS (6-11) is an 8-item self-administered questionnaire assessing daytime sleepiness in children under 12 years of age, adapted from the PDSS used in older children. It evaluates the impact of sleepiness on daily functioning, particularly at school, based on the frequency of daytime fatigue and sleep episodes. Scores range from 0 to 32.
Time frame: Baseline (V1) for group A and B and during the hospitalization visit at 2 months for group C
Correlation coefficients between the Pediatric Daytime Sleepiness Scale (PDSS; 6-11 years) and the Epworth Sleepiness Scale for Children and Adolescents (ESS-CHAD)
PDSS (6-11) is an 8-item self-administered questionnaire assessing daytime sleepiness in children under 12 years of age, adapted from the PDSS used in older children. It evaluates the impact of sleepiness on daily functioning, particularly at school, based on the frequency of daytime fatigue and sleep episodes. Scores range from 0 to 32. ESS-CHAD : an 8-item questionnaire designed to assess daytime sleepiness. Participants assign a score from 0 to 3 (0 = never; 1 = weak; 2 = moderate; 3 = strong).The minimum score is 0 and the maximum score is 24.
Time frame: Baseline (V1) and during the hospitalization visit at 2 months
Correlation coefficients between the Short Chronotype Questionnaire (µMunich) for children and adolescents (µMunich-E and µMunich-A) and the PDSS (12-17 years).
µMunich 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. Versions for children (6-11, µMunich-E) and adolescents (12-17, µMunich-A) are being validated. PDSS 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.
Time frame: Baseline (V1) for group A and B and during the hospitalization visit at 2 months for group C
Correlation coefficients between the Short Chronotype Questionnaire (µMunich) for children and adolescents (µMunich-E and µMunich-A) and the the Epworth Sleepiness Scale for Children and Adolescents (ESS-CHAD)
µMunich :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. Versions for children (6-11, µMunich-E) and adolescents (12-17, µMunich-A) are being validated. ESS-CHAD : an 8-item questionnaire designed to assess daytime sleepiness. Participants assign a score from 0 to 3 (0 = never; 1 = weak; 2 = moderate; 3 = strong).The minimum score is 0 and the maximum score is 24.
Time frame: Baseline (V1) and during the hospitalization visit at 2 months
Group differences in Pediatric Hypersomnolence Scale for children and adolescents (PHS; 6-11 and PHS; 12-17 years) scores.
Differences in mean PHS scores between diagnostic groups will be assessed using t-tests or analysis of variance (ANOVA), as appropriate. Analyses will be performed separately for PHS; 6-11 years and PHS; 12-17 years.
Time frame: Baseline (V1) for group A and B and during the hospitalization visit at 2 months for group C
Group differences in the Epworth Sleepiness Scale for children and adolescents (ESEA-E and ESEA-A) scores
Differences in mean ESEA scores between diagnostic groups will be assessed using t-tests or analysis of variance (ANOVA), as appropriate. Analyses will be performed separately for 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
Group differences in French Sleepiness Scale for children (FSSC-8) scores
Differences in mean FSSC-8 scores between diagnostic groups will be assessed using t-tests or analysis of variance (ANOVA), as appropriate.
Time frame: Baseline (V1) for group A and B and during the hospitalization visit at 2 months for group C
Group differences in Pediatric Daytime Sleepiness Scale (PDSS; 6-11 years) scores
Differences in mean PDSS scores between diagnostic groups will be assessed using t-tests or analysis of variance (ANOVA), as appropriate.
Time frame: Baseline (V1) for group A and B and during the hospitalization visit at 2 months for group C
Group differences in Idiopathic Hypersomnia Severity Scale for children and adolescents (IHSS-E and IHSS-A) scores
Differences in mean IHSS scores between diagnostic groups will be assessed using t-tests or analysis of variance (ANOVA), as appropriate. Analyses will be performed separately for IHSS-E and IHSS-A.
Time frame: Baseline (V1) for group A and B and during the hospitalization visit at 2 months for group C
Diagnostic performance of the Pediatric Hypersomnolence Scale (PHS)
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 Diagnostic performance will be assessed by estimating optimal cut-off values of PHS scores for pathological hypersomnolence. The following metrics will be reported at optimal thresholds: * Positive predictive value (PPV) * Negative predictive value (NPV) * Sensitivity (%) and specificity (%)
Time frame: Baseline (V1) for group A and B and during the hospitalization visit at 2 months for group C
Association between the Idiopathic Hypersomnia Severity Scale scores for children and adolescents (IHSS-E and IHSS-A) and Pediatric Hypersomnolence Scale (PHS) scores
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. Versions for children (6-11 years, IHSS-E) and adolescents (12-17 years, IHSS-A) are being validated. 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. The association between IHSS and PHS scores will be assessed using correlation coefficients
Time frame: Baseline (V1) for group A and B and during the hospitalization visit at 2 months for group C
Association between the Idiopathic Hypersomnia Severity Scale scores for children and adolescents (IHSS-A and IHSS-E ) and the sleepiness scale ESEA (ESEA-E and ESEA-A ) scores
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. Versions for children (6-11 years, IHSS-E) and adolescents (12-17 years, IHSS-A) are being validated. ESEA-A is a self-assessment questionnaire adapted from the Epworth Sleepiness Scale for adolescents (12-17 years). It evaluates daytime sleepiness in common daily situations. Scores range from 0 to 30, with the pathological threshold to be validated. A simplified version for children (6-11 years, ESEA-E) is also under validation. The association between IHSS and ESEA scores will be assessed using correlation coefficients
Time frame: Baseline (V1) for group A and B and during the hospitalization visit at 2 months for group C
Association between the Idiopathic Hypersomnia Severity Scale scores (IHSS-A and IHSS-E ) and the French Sleepiness Scale for children FSSC-8 scores.
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. Versions for children (6-11 years, IHSS-E) and adolescents (12-17 years, IHSS-A) are being validated. 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.The association between IHSS and FSSC-8 scores will be assessed using correlation coefficients
Time frame: Baseline (V1) for group A and B and during the hospitalization visit at 2 months for group C
Association betweenthe Idiopathic Hypersomnia Severity Scale scores for children and adolescents (IHSS-A and IHSS-E ) and the sleepiness scale PDSS (6-11 years) scores
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. Versions for children (6-11 years, IHSS-E) and adolescents (12-17 years, IHSS-A) are being validated. PDSS 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.The association between IHSS and PDSS scores will be assessed using correlation coefficients
Time frame: Baseline (V1) for group A and B and during the hospitalization visit at 2 months for group C
Association between the Idiopathic Hypersomnia Severity Scale scores for children and adolescents (IHSS-A and IHSS-E ) and Children's Depression Inventory (CDI) scores
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. Versions for children (6-11 years, IHSS-E) and adolescents (12-17 years, IHSS-A) are being validated. CDI is a 27-item self-report questionnaire assessing depressive symptom severity in children and adolescents over the past two weeks. Each item is scored 0-2 (total 0-54): 0-12 = no symptoms, 13-19 = mild to moderate, ≥20 = moderate to severe, possibly requiring clinical evaluation. The association between IHSS and CDI scores will be assessed using correlation coefficients
Time frame: Baseline (V1) and during the hospitalization visit at 2 months
Association between the Idiopathic Hypersomnia Severity Scale scores for children and adolescents (IHSS-A and IHSS-E ) and the Insomnia Severity Index (ISI) scores
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. Versions for children (6-11 years, IHSS-E) and adolescents (12-17 years, IHSS-A) are being validated. The Insomnia Severity Index (ISI) is a 7-item self-report questionnaire assessing the nature, severity of both nighttime and daytime components of insomnia, and impact of insomnia. Each item is scored 0 (no problem) - 4 (very big problem) with total between 0-28 (absence of insomnia (0-7); sub- threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28). The association between IHSS and ISI scores will be assessed using correlation coefficients
Time frame: Baseline (V1) and during the hospitalization visit at 2 months
Association between the Idiopathic Hypersomnia Severity Scale scores for children and adolescents (IHSS-A and IHSS-E ) and Quality of life VSP-A (6-11 years and 12-17 ans) scores.
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. Versions for children (6-11 years, IHSS-E) and adolescents (12-17 years, IHSS-A) are being validated. VSP-A is a self-administered questionnaire assessing health-related quality of life in adolescents aged 11-17, covering physical and psychological well-being, social and family relationships, self-perception, and school environment. It includes 39 Likert-scale items, with higher scores indicating better quality of life, and was developed and validated in French. A 38-item version for children aged 6-11 (VSP-A 6-11) is also available and routinely used at Lyon University Hospital.The association between IHSS and VSP-A scores will be assessed using correlation coefficients
Time frame: Baseline (V1) and during the hospitalization visit at 2 months
Actigraphy to detect the wake and sleep cycle
Actigraphy is a non-invasive test carried out using a device worn on the wrist over a period of one week. It aims to detect the pattern of waking and sleeping.
Time frame: After screening/enrollment visit (V1) for Group B and and after visit 2 (Hospitalization visit 60 days ± 15 days after visit 1) for Group C
Sleepiness severity scores measured on the Quality of life (VSP-A) scale
Description : The VSP-A is a self-administered questionnaire assessing health-related quality of life in adolescents aged 11-17, covering physical and psychological well-being, social and family relationships, self-perception, and school environment. It includes 39 Likert-scale items, with higher scores indicating better quality of life, and was developed and validated in French. A 38-item version for children aged 6-11 (VSP-A 6-11) is also available and routinely used at Lyon University Hospital
Time frame: During the hospitalization visit at 2 months
Sleepiness severity scores on the Insomnia Severity Index (ISI)
The Insomnia Severity Index (ISI) is a 7-item self-report questionnaire assessing the nature, severity of both nighttime and daytime components of insomnia, and impact of insomnia. Each item is scored 0 (no problem) - 4 (very big problem) with total between 0-28 (absence of insomnia (0-7); sub- threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28).
Time frame: During the hospitalization visit at 2 months
Sleepiness severity scores on the Pediatric Narcolepsy Severity Scale (NSS-P)
NSS-P is a 14-item questionnaire assessing the severity of narcolepsy symptoms in children and adolescents, including excessive daytime sleepiness, cataplexy, and other disorder-specific manifestations. Each item is scored to estimate overall symptom intensity (total 0-54): 0-14 = mild, 15-28 = moderate, 29-42 = severe, 43-54 = very severe. A score ≥1 on narcolepsy-specific items indicates pathological symptoms.
Time frame: During the hospitalization visit at 2 months
Sleepiness severity scores on the Children's Depression Inventory (CDI)
The CDI is a 27-item self-report questionnaire assessing depressive symptom severity in children and adolescents over the past two weeks. Each item is scored 0-2 (total 0-54): 0-12 = no symptoms, 13-19 = mild to moderate, ≥20 = moderate to severe, possibly requiring clinical evaluation.
Time frame: During the hospitalization visit at 2 months
Clinical Global Impression Scale for Severity (CGI-S)
CGI-S is an observer-rated scale measuring illness severity on a 7-point scale: 1 = "normal, not at all ill," 2 = "borderline ill," 3 = "slightly ill," 4 = "moderately ill," 5 = "markedly ill," 6 = "severely ill," 7 = "among the most extremely ill patients." Only completed for group B subjects.
Time frame: During the hospitalization visit at 2 months
Clinical Global Impression Scale for Change (CGI-C)
CGI-C : The Clinical Global Impression of Severity (CGI-S) is a global rating scale used for clinician-rated assessment of the severity of a disorder. It consists of a single item asking the clinician to rate, on an ordinal scale from 1 to 7, the overall severity of the patient's condition at the time of assessment. This rating is based on clinical observation and available information regarding the patient's overall functioning. Only completed for group B subjects.
Time frame: During the hospitalization visit at 2 months
Procrastination Severity
PPS-A (Pure Procrastination Scale ) is an 11-item self-report questionnaire assessing procrastination behaviors in adolescents and adults. For children under 12, an age-adapted version (PPS-E) is used. It evaluates cognitive and behavioral aspects, such as delaying important tasks, difficulty initiating action, and loss of control with deadlines, as well as their impact on school, work, and daily activities. Scores range from 11 to 55, with significant procrastination typically indicated by a score ≥45 (75th percentile). Only completed for group B and C subjects.
Time frame: During the hospitalization visit at 2 months
Concentration of CSF orexinA/hypocretin in NT1 patient
Determination orexinA/hypocretin in cerebrospinal fluid (CSF). Only in Group B in case of suspected narcolepsy.
Time frame: During the hospitalization visit at 2 months
Urinary melatonin concentration
Measurement of urinary 5-sulfatoxymelatonin as an indicator of melatonin secretion. Only done for groups B and C.
Time frame: During the hospitalization visit at 2 months
Normative values scores in the Pediatric Hypersomnia Survey PHS (6-11years and 12-17 years).
\- means, standard deviations, and percentiles PHS: Scores range from 0 to 42, with a pathological threshold \>24 for narcolepsy/hypersomnia
Time frame: Baseline (V1) for group A and B and during the hospitalization visit at 2 months for group C
Normative values scores in the ESEA-E (6-11years) and ESEA-A (12-17years) versions of the Epworth Sleepiness Scale (ESEA)
\- means, standard deviations, and percentiles ESEA : Scores range from 0 to 30.
Time frame: Baseline (V1) for group A and B and during the hospitalization visit at the 2 months for group C
Normative values scores in the French Sleepiness Scale for children (FSSC-8)
* means, standard deviations, and percentiles * FSSC-8: Scores range from 0 to 24
Time frame: Baseline (V1) for group A and B and during the hospitalization visit at 2 months for group C
Normative values scores in the Pediatric Daytime Sleepiness Scale (PDSS; 6-11years)
* means, standard deviations, and percentiles * PDSS : Scores range from 0 to 32.
Time frame: Baseline (V1) for group A and B and during the hospitalization visit at 2 months for group C
Normative values scores in the IHSS-E (6-11years) and IHSS-A (12-17years) versions of the Idiopathic Hypersomnia Severity Scale (IHSS)
* means, standard deviations, and percentiles * IHSS : scores range from 0 to 50.
Time frame: Baseline (V1) for group A and B and during the hospitalization visit at 2 months for group C
Normative values scores in the Short Chronotype Questionnaire μMunich (μMunich-E and μMunich-A versions)
means, standard deviations, and percentiles
Time frame: Baseline (V1) for group A and B and during the hospitalization visit at 2 months for group C
24-hour Ambulatory Blood Pressure Profile
Assessment of the 24-hour blood pressure profile using automated, non-invasive ambulatory blood pressure monitoring (ABPM), with repeated systolic and diastolic blood pressure measurements. Unit of Measure: mmHg Only for patients with suspected narcolepsy and for subjects in group C.
Time frame: During the hospitalization visit at 2 months
Psychomotor vigilance task (PVT)
PVT is a widely utilized as a measure of behavioral alertness, primary due to its high sensitivity to sleep deprivation and its psychometric advantages over other cognitive tests. The standard 10-min PVT measures sustained or vigilant attention by recording response times (RT) to visual (or auditory) stimuli presented at random inter-stimulus intervals. Only done for groups B and C subjects.
Time frame: During the hospitalization visit at 2 months
Mean sleep latency
MSLT (Multiple Sleep Latency Test): A daytime sleep study that measures how quickly a person falls asleep during several scheduled naps. It checks sleep latency and the presence of SOREMPs. Used mainly to diagnose narcolepsy and excessive daytime sleepiness. Only done for groups B and C subjects.
Time frame: During the hospitalization visit at 2 months
Number of sleep-onset REM periods
MSLT (Multiple Sleep Latency Test): A daytime sleep study that measures how quickly a person falls asleep during several scheduled naps. It checks sleep latency and the presence of SOREMPs. Used mainly to diagnose narcolepsy and excessive daytime sleepiness. Only done for groups B and C subjects.
Time frame: During the hospitalization visit at 2 months
Sleep latency at each test (minutes)
MSLT (Multiple Sleep Latency Test): A daytime sleep study that measures how quickly a person falls asleep during several scheduled naps. It checks sleep latency and the presence of SOREMPs. Used mainly to diagnose narcolepsy and excessive daytime sleepiness. Only done for groups B and C subjects.
Time frame: During the hospitalization visit at 2 months
Presence of a SOREMP at each test
MSLT (Multiple Sleep Latency Test): A daytime sleep study that measures how quickly a person falls asleep during several scheduled naps. It checks sleep latency and the presence of SOREMPs. Used mainly to diagnose narcolepsy and excessive daytime sleepiness. Only done for groups B and C subjects.
Time frame: During the hospitalization visit at 2 months
Percentage of sleep efficiency
is measured in percentage (%) during polysomnography and indicates the proportion of time spent asleep relative to the total time in bed. Only done for groups B and C subjects.
Time frame: During the hospitalization visit at 2 months
Total sleep time
Total sleep time measured in minutes during polysomnography. Only done for groups B and C subjects.
Time frame: During the hospitalization visit at 2 months
Sleep onset latency (in minutes)
Sleep onset Latensy measured in minutes during polysomnography. Only done for groups B and C subjects.
Time frame: During the hospitalization visit at 2 months
Wake after sleep onset - WASO (in minutes)
WASO is defined as the time to wake after initial sleep onset. WASO is measured during overnight sleep laboratory (PSG) assessment and defined as the duration of wakefulness from the onset of persistent sleep. Only done for groups B and C subjects.
Time frame: During the hospitalization visit at 2 months
Percentage of different sleep stages
Percentage of time spent in stage 1 and 2 sleep stages and stage 3 during polysomnography. Only done for groups B and C subjects.
Time frame: During the hospitalization visit at 2 months
Rapid Eye Movement sleep latency - REM (in minutes)
Time spent in REM sleep is measured in minutes during polysomnography. Only done for groups B and C subjects.
Time frame: During the hospitalization visit at 2 months
Respiratory event index - REI (events per hour)
REI is calculated from the number of apneas and hypopneas per hour of sleep (AHI = number of apneas + number of hypopneas / number of hours of sleep) during polysomnography. Only done for groups B and C subjects.
Time frame: During the hospitalization visit at 2 months
Periodic limb movement index - PLMI (events per hour)
PLMI is measured in events per hour and counts the average number of periodic limb movements per hour of sleep during Polysomnography. Only done for groups B and C subjects.
Time frame: During the hospitalization visit at 2 months
Phasic and tonic muscle activity during REM sleep (in percentage).
Phasic and tonic muscle activity during REM sleep is measured in percentage (%) during polysomnography and quantifies abnormal muscle activity during REM sleep. Only done for groups B and C subjects.
Time frame: During the hospitalization visit at 2 months
Deep slow-wave sleep fragmentation index (events per hour)
Deep slow-wave sleep fragmentation index is measured in events per hour during polysomnography and represents the number of arousals or interruptions of deep sleep per hour. Only done for groups B and C subjects.
Time frame: During the hospitalization visit at 2 months
Complex motor behaviors on video recording (number per night)
Complex motor behaviors on video recording is measured in number per night during polysomnography and counts the frequency of abnormal or complex motor behaviors observed during the night. Only done for groups B and C subjects.
Time frame: During the hospitalization visit at 2 months
Continuous long-duration 24-hour sleep recording data (in minutes)
Continuous long-duration 24-hour sleep recording data is measured in minutes during polysomnography and represents the total duration of sleep recorded over a continuous 24-hour period. Only done for groups B and C subjects.
Time frame: During the hospitalization visit at 2 months
Discriminative ability of French Sleepiness Scale for children (FSSC-8) for pathological hypersomnolence
Discriminative ability will be evaluated using receiver operating characteristic (ROC) curve analysis. The following metrics will be reported: • Area Under the Curve (AUC)
Time frame: Baseline (V1) for group A and B and during the hospitalization visit at 2 months for group C]
Discriminative ability of Pediatric Daytime Sleepiness Scale (PDSS) for pathological hypersomnolence
Discriminative ability will be evaluated using receiver operating characteristic (ROC) curve analysis. The following metrics will be reported: • Area Under the Curve (AUC)
Time frame: Baseline (V1) for group A and B and during the hospitalization visit at 2 months for group C]
Discriminative ability of the Idiopatic Hypersomnia Severity Scale (IHSS-A and IHSS-E ) for pathological hyperomnolence
Discriminative ability will be evaluated using receiver operating characteristic (ROC) curve analysis. The following metrics will be reported: • Area Under the Curve (AUC) Analyses will be performed separately for: * IHSS-A (6-11 years) * IHSS-E (12-17 years)
Time frame: Baseline (V1) for group A and B and during the hospitalization visit at 2 months for group C
Discriminative ability of Pediatric Hypersomnia Survey (PHS) for pathological hypersomnolence
Discriminative ability will be evaluated using receiver operating characteristic (ROC) curve analysis. The following metrics will be reported: • Area Under the Curve (AUC)
Time frame: Baseline (V1) for group A and B and during the hospitalization visit at 2 months for group C
Discriminative ability of the Epworth Sleepiness Scale for Children and Adolescents (ESEA-E and ESEA-A) for pathological hypersomnolence
Discriminative ability will be evaluated using receiver operating characteristic (ROC) curve analysis. The following metrics will be reported: • Area Under the Curve (AUC) Analyses will be performed separately for: * ESEA-E (6-11 years) * ESEA-A (12-17 years) Subgroup analyses will include general population vs referred clinical population.
Time frame: Baseline (V1) for group A and B and during the hospitalization visit at 2 months for group C
Discriminative ability of the Short Chronotype Questionnaire (µMunich-E and µMunich-A) for pathological hyperomnolence
Discriminative ability will be evaluated using receiver operating characteristic (ROC) curve analysis. The following metrics will be reported: • Area Under the Curve (AUC) Analyses will be performed separately for: • µMunich-E (6-11 years) • µMunich-A(12-17 years)
Time frame: Baseline (V1) for group A and B and during the hospitalization visit at 2 months for group C
Construct validity of the Epworth Sleepiness Scale for Children and Adolescents (ESEA-E and ESEA-A): Number of dimensions
Construct validity will be assessed using multiple correspondence analysis (MCA) for categorical items. The number of dimensions retained will be determined based on eigenvalues \>1 and inspection of the scree plot. Measure: Number of dimensions retained (dimension count). Results will be reported separately for each version of the scale.
Time frame: Baseline (V1) for group A and B and during the hospitalization visit at 2 months for group C
Construct validity of the the Idiopathic Hypersomnia Severity Scale (IHSS) for children and adolescents(IHSS-E and IHSS-A): Number of dimensions
Construct validity will be assessed using multiple correspondence analysis (MCA) for categorical items. The number of dimensions retained will be determined based on eigenvalues \>1 and inspection of the scree plot. Measure: Number of dimensions retained (dimension count). Results will be reported separately for each version of the scale.
Time frame: Baseline (V1) for group A and B and during the hospitalization visit at 2 months for group C
Construct validity of the Pediatric Daytime Sleepiness Scale (PDSS) for children (6-11years): Number of dimensions
Construct validity will be assessed using multiple correspondence analysis (MCA) for categorical items. The number of dimensions retained will be determined based on eigenvalues \>1 and inspection of the scree plot. Measure: Number of dimensions retained (dimension count).
Time frame: Baseline (V1) for group A and B and during the hospitalization visit at 2 months for group C
Construct validity of the French Sleepiness Scale for children (FSSC-8): Number of dimensions
Construct validity will be assessed using multiple correspondence analysis (MCA) for categorical items. The number of dimensions retained will be determined based on eigenvalues \>1 and inspection of the scree plot. Measure: Number of dimensions retained (dimension count).
Time frame: Baseline (V1) for group A and B and during the hospitalization visit at 2 months for group C
Construct validity of the Pediatric Hypersomnia Survey (PHS) for children (6-11 years) and adolescents (12-17 years): Number of dimensions
Construct validity will be assessed using multiple correspondence analysis (MCA) for categorical items. The number of dimensions retained will be determined based on eigenvalues \>1 and inspection of the scree plot. Measure: Number of dimensions retained (dimension count). Results will be reported separately for each version of the scale.
Time frame: Baseline (V1) for group A and B and during the hospitalization visit at 2 months for group C
Construct validity of the Short Chronotype Questionnaire (µMunich) for children and adolescents (µMunich-E and µMunich-A): Number of dimensions
Construct validity will be assessed using multiple correspondence analysis (MCA) for categorical items. The number of dimensions retained will be determined based on eigenvalues \>1 and inspection of the scree plot. Measure: Number of dimensions retained (dimension count). Results will be reported separately for each version of the scale.
Time frame: Baseline (V1) for group A and B and during the hospitalization visit at 2 months for group C
24-hour Ambulatory Heart Rate Profile
Assessment of the 24-hour heart rate profile using automated ambulatory monitoring with repeated heart rate measurements. Unit of Measure: beats per minute (bpm)
Time frame: During the hospitalization visit at 2 months
Construct validity of the Epworth Sleepiness Scale for Children and Adolescents (ESEA-E and ESEA-A): Coordinates of item categories
Construct validity will be assessed using multiple correspondence analysis (MCA) for categorical items. The coordinates of the item categories on each retained dimension will be reported to describe the position and contribution of each response category within the MCA solution. Measure: Coordinates of item categories on each retained MCA dimension (dimension-specific coordinates; no physical unit). Results will be reported separately for each version of the scale.
Time frame: Baseline (V1) for Groups A and B and during the hospitalization visit at 2 months for Group C
Construct validity of the the Idiopathic Hypersomnia Severity Scale (IHSS) for children and adolescents(IHSS-E and IHSS-A) : Coordinates of item categories
Construct validity will be assessed using multiple correspondence analysis (MCA) for categorical items. The coordinates of the item categories on each retained dimension will be reported to describe the position and contribution of each response category within the MCA solution. Measure: Coordinates of item categories on each retained MCA dimension (dimension-specific coordinates; no physical unit). Results will be reported separately for each version of the scale.
Time frame: Baseline (V1) for group A and B and during the hospitalization visit at 2 months for group C
Construct validity of the Pediatric Daytime Sleepiness Scale (PDSS) for children (6-11years) : Coordinates of item categories
Construct validity will be assessed using multiple correspondence analysis (MCA) for categorical items. The coordinates of the item categories on each retained dimension will be reported to describe the position and contribution of each response category within the MCA solution. Measure: Coordinates of item categories on each retained MCA dimension (dimension-specific coordinates; no physical unit).
Time frame: Baseline (V1) for group A and B and during the hospitalization visit at 2 months for group C
Construct validity of the French Sleepiness Scale for children (FSSC-8): Coordinates of item categories
Construct validity will be assessed using multiple correspondence analysis (MCA) for categorical items. The coordinates of the item categories on each retained dimension will be reported to describe the position and contribution of each response category within the MCA solution. Measure: Coordinates of item categories on each retained MCA dimension (dimension-specific coordinates; no physical unit).
Time frame: Baseline (V1) for group A and B and during the hospitalization visit at 2 months for group C
Construct validity of the Pediatric Hypersomnia Survey (PHS) for children (6-11 years) and adolescents (12-17 years) : Coordinates of item categories
Construct validity will be assessed using multiple correspondence analysis (MCA) for categorical items. The coordinates of the item categories on each retained dimension will be reported to describe the position and contribution of each response category within the MCA solution. Measure: Coordinates of item categories on each retained MCA dimension (dimension-specific coordinates; no physical unit). Results will be reported separately for each version of the scale
Time frame: Baseline (V1) for group A and B and during the hospitalization visit at 2 months for group C
Construct validity of the Short Chronotype Questionnaire (µMunich) for children and adolescents (µMunich-E and µMunich-A) : Coordinates of item categories
Construct validity will be assessed using multiple correspondence analysis (MCA) for categorical items. The coordinates of the item categories on each retained dimension will be reported to describe the position and contribution of each response category within the MCA solution. Measure: Coordinates of item categories on each retained MCA dimension (dimension-specific coordinates; no physical unit). Results will be reported separately for each version of the scale.
Time frame: Baseline (V1) for group A and B and during the hospitalization visit at 2 months for group C
Plan to share: No
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Start is estimated for Sep 2026; primary completion for May 2029, 32 months later.
Of 21 interventional studies with no phase under Narcolepsy, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 42. This study's planned 32 months is above that.
How these figures are worked out, and which studies are left out of them.
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University Hospital, Montpellier →