Wakefulness Disorder, Narcolepsy, Idiopathic Hypersomnia
Conditions
Keywords
sleep disorders, sleepiness, pediatric, screening, phenotyping, scales, psychometric measurements, biological collection
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.
Detailed description
"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.
Interventions
OTHERSleepness 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
PROCEDUREPolysomnography
Polysomnography over 24 hours
PROCEDUREActimetry
Actimetry over 2 weeks
OTHERDiagnostic 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
Ambulatory blood pressure monitoring (ABPM) over 24 hours
OTHERblood sampling
10 mL of blood are taken
OTHERUrine 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
University Hospital, Montpellier
Société Française de Recherche et de Médecine du Sommeil
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
Yes
Inclusion criteria
* 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: 1. 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. 2. 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). * OR * 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: <!-- --> 1. Mean sleep latency (TILE) ≤ 8 minutes, 2. 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). 3. 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. * Confirmation by sleep diaries or actigraphy over ≥7 days. * Absence of comorbidities that primarily alter the circadian rhythm (e.g., narcolepsy, unstable psychiatric disorders, substance use). 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: * Apnea + hypopnea index ≥ 1 event/hour in patients under 18 years of age, * Plus an associated symptom (snoring, breathing difficulties, daytime sleepiness, or behavioral disorders), * Diagnosis confirmed by a second examination if the first is inconclusive or in the event of comorbidity (obesity, craniofacial malformations). 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 DSM-5, 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 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. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Internal consistency of the Short Chronotype Questionnaire (µMunich) for children and adolescents (µMunich-E and µMunich-A) | Baseline (V1) for group A and B and during the hospitalization visit at 2 months for group C | 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. |
| Internal consistency of the Idiopathic Hypersomnia Severity Scale (IHSS) for children and adolescents(IHSS-E and IHSS-A) | Baseline (V1) for group A and B and during the hospitalization visit at 2 months for group C | 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. |
| Internal consistency of the Pediatric Daytime Sleepiness Scale (PDSS) for children (6-11 years) | Baseline (V1) for group A and B and during the hospitalization visit at 2 months for group C | 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. |
| Internal consistency of the French Sleepiness Scale for children (FSSC-8) | Baseline (V1) for group A and B and during the hospitalization visit at 2 months for group C | 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. |
| Internal consistency of the Pediatric Hypersomnia Survey (PHS) for children (6-11 years) and adolescents (12-17 years) | Baseline (V1) for group A and B and during the hospitalization visit at 2 months for group C | 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 |
| Internal consistency of the Epworth Sleepiness Scale for Children and Adolescents (ESEA-E and ESEA-A) | Baseline (V1) for group A and B and during the hospitalization visit at 2 months for group C | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Global Impression Scale for Change (CGI-C) | During the hospitalization visit at 2 months | 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. |
| Construct validity of the Short Chronotype Questionnaire (µMunich) for children and adolescents (µMunich-E and µMunich-A): Number of dimensions | Baseline (V1) for group A and B and during the hospitalization visit at 2 months for group C | 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. |
| 24-hour Ambulatory Heart Rate Profile | During the hospitalization visit at 2 months | Assessment of the 24-hour heart rate profile using automated ambulatory monitoring with repeated heart rate measurements. Unit of Measure: beats per minute (bpm) |
| Procrastination Severity | During the hospitalization visit at 2 months | 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. |
| Concentration of CSF orexinA/hypocretin in NT1 patient | During the hospitalization visit at 2 months | Determination orexinA/hypocretin in cerebrospinal fluid (CSF). Only in Group B in case of suspected narcolepsy. |
| Urinary melatonin concentration | During the hospitalization visit at 2 months | Measurement of urinary 5-sulfatoxymelatonin as an indicator of melatonin secretion. Only done for groups B and C. |
| Normative values scores in the Pediatric Hypersomnia Survey PHS (6-11years and 12-17 years). | Baseline (V1) for group A and B and during the hospitalization visit at 2 months for group C | \- means, standard deviations, and percentiles PHS: Scores range from 0 to 42, with a pathological threshold \>24 for narcolepsy/hypersomnia |
| Normative values scores in the ESEA-E (6-11years) and ESEA-A (12-17years) versions of the Epworth Sleepiness Scale (ESEA) | Baseline (V1) for group A and B and during the hospitalization visit at the 2 months for group C | \- means, standard deviations, and percentiles ESEA : Scores range from 0 to 30. |
| Normative values scores in the French Sleepiness Scale for children (FSSC-8) | Baseline (V1) for group A and B and during the hospitalization visit at 2 months for group C | * means, standard deviations, and percentiles * FSSC-8: Scores range from 0 to 24 |
| Normative values scores in the Pediatric Daytime Sleepiness Scale (PDSS; 6-11years) | Baseline (V1) for group A and B and during the hospitalization visit at 2 months for group C | * means, standard deviations, and percentiles * PDSS : Scores range from 0 to 32. |
| Normative values scores in the IHSS-E (6-11years) and IHSS-A (12-17years) versions of the Idiopathic Hypersomnia Severity Scale (IHSS) | Baseline (V1) for group A and B and during the hospitalization visit at 2 months for group C | * means, standard deviations, and percentiles * IHSS : scores range from 0 to 50. |
| Normative values scores in the Short Chronotype Questionnaire μMunich (μMunich-E and μMunich-A versions) | Baseline (V1) for group A and B and during the hospitalization visit at 2 months for group C | means, standard deviations, and percentiles |
| 24-hour Ambulatory Blood Pressure Profile | During the hospitalization visit at 2 months | 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. |
| Psychomotor vigilance task (PVT) | During the hospitalization visit at 2 months | 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. |
| Mean sleep latency | During the hospitalization visit at 2 months | 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. |
| Number of sleep-onset REM periods | During the hospitalization visit at 2 months | 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. |
| Sleep latency at each test (minutes) | During the hospitalization visit at 2 months | 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. |
| Presence of a SOREMP at each test | During the hospitalization visit at 2 months | 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. |
| Percentage of sleep efficiency | During the hospitalization visit at 2 months | 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. |
| Total sleep time | During the hospitalization visit at 2 months | Total sleep time measured in minutes during polysomnography. Only done for groups B and C subjects. |
| Sleep onset latency (in minutes) | During the hospitalization visit at 2 months | Sleep onset Latensy measured in minutes during polysomnography. Only done for groups B and C subjects. |
| Wake after sleep onset - WASO (in minutes) | During the hospitalization visit at 2 months | 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. |
| Percentage of different sleep stages | During the hospitalization visit at 2 months | Percentage of time spent in stage 1 and 2 sleep stages and stage 3 during polysomnography. Only done for groups B and C subjects. |
| Rapid Eye Movement sleep latency - REM (in minutes) | During the hospitalization visit at 2 months | Time spent in REM sleep is measured in minutes during polysomnography. Only done for groups B and C subjects. |
| Respiratory event index - REI (events per hour) | During the hospitalization visit at 2 months | 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. |
| Periodic limb movement index - PLMI (events per hour) | During the hospitalization visit at 2 months | 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. |
| Phasic and tonic muscle activity during REM sleep (in percentage). | During the hospitalization visit at 2 months | 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. |
| Deep slow-wave sleep fragmentation index (events per hour) | During the hospitalization visit at 2 months | 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. |
| Complex motor behaviors on video recording (number per night) | During the hospitalization visit at 2 months | 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. |
| Continuous long-duration 24-hour sleep recording data (in minutes) | During the hospitalization visit at 2 months | 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. |
| Discriminative ability of French Sleepiness Scale for children (FSSC-8) for pathological hypersomnolence | Baseline (V1) for group A and B and during the hospitalization visit at 2 months for group C] | Discriminative ability will be evaluated using receiver operating characteristic (ROC) curve analysis. The following metrics will be reported: • Area Under the Curve (AUC) |
| Discriminative ability of Pediatric Daytime Sleepiness Scale (PDSS) for pathological hypersomnolence | Baseline (V1) for group A and B and during the hospitalization visit at 2 months for group C] | Discriminative ability will be evaluated using receiver operating characteristic (ROC) curve analysis. The following metrics will be reported: • Area Under the Curve (AUC) |
| Discriminative ability of the Idiopatic Hypersomnia Severity Scale (IHSS-A and IHSS-E ) for pathological hyperomnolence | Baseline (V1) for group A and B and during the hospitalization visit at 2 months for group C | 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) |
| Discriminative ability of Pediatric Hypersomnia Survey (PHS) for pathological hypersomnolence | Baseline (V1) for group A and B and during the hospitalization visit at 2 months for group C | Discriminative ability will be evaluated using receiver operating characteristic (ROC) curve analysis. The following metrics will be reported: • Area Under the Curve (AUC) |
| Discriminative ability of the Epworth Sleepiness Scale for Children and Adolescents (ESEA-E and ESEA-A) for pathological hypersomnolence | Baseline (V1) for group A and B and during the hospitalization visit at 2 months for group C | 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. |
| Discriminative ability of the Short Chronotype Questionnaire (µMunich-E and µMunich-A) for pathological hyperomnolence | Baseline (V1) for group A and B and during the hospitalization visit at 2 months for group C | 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) |
| Construct validity of the Epworth Sleepiness Scale for Children and Adolescents (ESEA-E and ESEA-A): Number of dimensions | Baseline (V1) for group A and B and during the hospitalization visit at 2 months for group C | 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. |
| Construct validity of the the Idiopathic Hypersomnia Severity Scale (IHSS) for children and adolescents(IHSS-E and IHSS-A): Number of dimensions | Baseline (V1) for group A and B and during the hospitalization visit at 2 months for group C | 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. |
| Construct validity of the Pediatric Daytime Sleepiness Scale (PDSS) for children (6-11years): Number of dimensions | Baseline (V1) for group A and B and during the hospitalization visit at 2 months for group C | 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). |
| Construct validity of the French Sleepiness Scale for children (FSSC-8): Number of dimensions | Baseline (V1) for group A and B and during the hospitalization visit at 2 months for group C | 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). |
| Construct validity of the Pediatric Hypersomnia Survey (PHS) for children (6-11 years) and adolescents (12-17 years): Number of dimensions | Baseline (V1) for group A and B and during the hospitalization visit at 2 months for group C | 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. |
| Construct validity of the Epworth Sleepiness Scale for Children and Adolescents (ESEA-E and ESEA-A): Coordinates of item categories | Baseline (V1) for Groups A and B and during the hospitalization visit at 2 months for Group C | 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. |
| 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 | 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 |
| 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 | 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. |
| 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 | 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. |
| 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 | 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. |
| 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 | 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. |
| 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) | Baseline (V1) and during the hospitalization visit at 2 months | 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. |
| Correlation coefficients between the French Sleepiness Scale for children (FSSC-8) 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 | 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. |
| Correlation coefficients between the Pediatric Daytime Sleepiness Scale (PDSS; 6-11 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 | 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. |
| Correlation coefficients between the Pediatric Daytime Sleepiness Scale (PDSS; 6-11 years) and the Epworth Sleepiness Scale for Children and Adolescents (ESS-CHAD) | Baseline (V1) and during the hospitalization visit at 2 months | 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. |
| Correlation coefficients between the Short Chronotype Questionnaire (µMunich) for children and adolescents (µMunich-E and µMunich-A) and the PDSS (12-17 years). | Baseline (V1) for group A and B and during the hospitalization visit at 2 months for group C | 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. |
| 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) | Baseline (V1) and during the hospitalization visit at 2 months | 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. |
| Group differences in Pediatric Hypersomnolence Scale for children and adolescents (PHS; 6-11 and PHS; 12-17 years) scores. | Baseline (V1) for group A and B and during the hospitalization visit at 2 months for group C | 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. |
| Group differences in the Epworth Sleepiness Scale for children and adolescents (ESEA-E and ESEA-A) scores | Baseline (V1) for group A and B and during the hospitalization visit at 2 months for group C | 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 |
| Group differences in French Sleepiness Scale for children (FSSC-8) scores | Baseline (V1) for group A and B and during the hospitalization visit at 2 months for group C | Differences in mean FSSC-8 scores between diagnostic groups will be assessed using t-tests or analysis of variance (ANOVA), as appropriate. |
| Group differences in Pediatric Daytime Sleepiness Scale (PDSS; 6-11 years) scores | Baseline (V1) for group A and B and during the hospitalization visit at 2 months for group C | Differences in mean PDSS scores between diagnostic groups will be assessed using t-tests or analysis of variance (ANOVA), as appropriate. |
| Group differences in Idiopathic Hypersomnia Severity Scale for children and adolescents (IHSS-E and IHSS-A) scores | Baseline (V1) for group A and B and during the hospitalization visit at 2 months for group C | 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. |
| Diagnostic performance of the Pediatric Hypersomnolence Scale (PHS) | Baseline (V1) for group A and B and during the hospitalization visit at 2 months for group C | 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 (%) |
| Association between the Idiopathic Hypersomnia Severity Scale scores for children and adolescents (IHSS-E and IHSS-A) and Pediatric Hypersomnolence Scale (PHS) scores | Baseline (V1) for group A and B and during the hospitalization visit at 2 months for group C | 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 |
| 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 | Baseline (V1) for group A and B and during the hospitalization visit at 2 months for group C | 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 |
| Association between the Idiopathic Hypersomnia Severity Scale scores (IHSS-A and IHSS-E ) and the French Sleepiness Scale for children FSSC-8 scores. | Baseline (V1) for group A and B and during the hospitalization visit at 2 months for group C | 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 |
| 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 | Baseline (V1) for group A and B and during the hospitalization visit at 2 months for group C | 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 |
| Association between the Idiopathic Hypersomnia Severity Scale scores for children and adolescents (IHSS-A and IHSS-E ) and Children's Depression Inventory (CDI) scores | Baseline (V1) and during the hospitalization visit at 2 months | 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 |
| Association between the Idiopathic Hypersomnia Severity Scale scores for children and adolescents (IHSS-A and IHSS-E ) and the Insomnia Severity Index (ISI) scores | Baseline (V1) and during the hospitalization visit at 2 months | 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 |
| 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. | Baseline (V1) and during the hospitalization visit at 2 months | 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 |
| Actigraphy to detect the wake and sleep cycle | 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 | 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. |
| Construct validity of the the Idiopathic Hypersomnia Severity Scale (IHSS) for children and adolescents(IHSS-E and IHSS-A) : Coordinates of item categories | Baseline (V1) for group A and B and during the hospitalization visit at 2 months for group C | 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. |
| Construct validity of the Pediatric Daytime Sleepiness Scale (PDSS) for children (6-11years) : Coordinates of item categories | Baseline (V1) for group A and B and during the hospitalization visit at 2 months for group C | 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). |
| Construct validity of the French Sleepiness Scale for children (FSSC-8): Coordinates of item categories | Baseline (V1) for group A and B and during the hospitalization visit at 2 months for group C | 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). |
| Construct validity of the Pediatric Hypersomnia Survey (PHS) for children (6-11 years) and adolescents (12-17 years) : Coordinates of item categories | Baseline (V1) for group A and B and during the hospitalization visit at 2 months for group C | 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 |
| Construct validity of the Short Chronotype Questionnaire (µMunich) for children and adolescents (µMunich-E and µMunich-A) : Coordinates of item categories | Baseline (V1) for group A and B and during the hospitalization visit at 2 months for group C | 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. |
| Sleepiness severity scores measured on the Quality of life (VSP-A) scale | During the hospitalization visit at 2 months | 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 |
| Sleepiness severity scores on the Insomnia Severity Index (ISI) | During the hospitalization visit at 2 months | 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). |
| Sleepiness severity scores on the Pediatric Narcolepsy Severity Scale (NSS-P) | During the hospitalization visit at 2 months | 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. |
| Sleepiness severity scores on the Children's Depression Inventory (CDI) | During the hospitalization visit at 2 months | 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. |
| Clinical Global Impression Scale for Severity (CGI-S) | During the hospitalization visit at 2 months | 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. |
Countries
France
Contacts
CONTACTLucie BARATEAU, Dr
Outcome results
None listed