An observational study in Hypersomnia and Sleepiness, Excessive Daytime, sponsored by Hospices Civils de Lyon. Completed at 1 site in France. Open to participants aged 6 Years to 18 Years. Per ClinicalTrials.gov, last updated 2025-02-24.
Sponsored by Hospices Civils de Lyon · Observational
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Among 30 studies in Disorders of Excessive Somnolence with a site in France — 9 open to participants now, 10 under way, 4 of them phase 3. Disorders of Excessive Somnolence · France.
Among the 30 studies in Disorders of Excessive Somnolence with a site in France, this one is the only one that started in 2022, is one of 6 observational ones, and was the 17th registered.
196 studies on the registry are indexed under Disorders of Excessive Somnolence; 34 are open to participants now.
Browse Disorders of Excessive Somnolence studies →9 of the 30 studies in Disorders of Excessive Somnolence with a site in France are open now. Recruiting first, the newest first:
Alkermes, Inc. · Sites in France, United States, Australia and 7 more countries
Ages 18–70
Alkermes, Inc. · Sites in France, United States, Australia and 7 more countries
Ages 18–70
University Hospital, Bordeaux · Sites in France
Ages 18–65 · Healthy volunteers
Alkermes, Inc. · Sites in France, United States, Australia and 5 more countries
Ages 18–70
Hospices Civils de Lyon · Sites in France
Ages 18–65
A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →
Of the 30 Disorders of Excessive Somnolence studies recruiting now, 12 (40%) set no upper age limit and 17 (57%) stop at 75 or younger; 5 take children under 18; 7 take healthy volunteers.
This study: 6 Years to 18 Years · all sexes · no healthy volunteers.
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30 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 2 7 · Phase 3 13
First in 2003; this study’s year is marked. 1 started in 2022.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 116 is above the median of 104 across 29 observational studies indexed under Disorders of Excessive Somnolence.
Median enrollment 130 across the 24 interventional studies, 110 across the 6 observational. Of the 19 that completed or were terminated, 3 (16%) have results posted.
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9 of 30 have an industry lead sponsor. The 10 most frequent:
Hospices Civils de Lyon is the lead sponsor of 1,867 studies on the registry; 448 are open to participants now.
Hospices Civils de Lyon has 4 studies filed under Disorders of Excessive Somnolence — fewer than ten, so there is no comparison to draw.
7 of the studies in Disorders of Excessive Somnolence with a site in France that are under way reach primary completion within a year, 3 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06366464Phase 3Harmony Biosciences Management, Inc.A Study of Pitolisant in Patients With Prader-Willi Syndrome | 2027-04 |
| NCT07502443Phase 3Alkermes, Inc.A Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 2 | 2027-05 |
| NCT07455383Phase 3Alkermes, Inc.A Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 1 | 2027-05 |
| NCT06843590Alkermes, Inc.A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Idiopathic Hypersomnia | 2026-11 |
| NCT06457945Hospices Civils de LyonMind-wandering and Predictive Processes in Narcolepsy: a Putative Mechanism Through Covert REM Intrusions | 2026-12-03 |
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Among the 30 studies in Disorders of Excessive Somnolence with a site in France, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Excessive diurnal sleepiness is characterized by an incapacity to stay awake, in favour of sleep occurrence. This sleepiness might be secondary to a sleep disorder; when it is not the case, it is primary hypersomnia (including narcolepsy and idiopathic hypersomnia).
To date, objective measures of sleepiness can only be achieved in laboratory. Subjective techniques as scales and questionnaires are highly sensitive to inter-individual differences and cannot constitute a reliable diagnosis tool of sleepiness.
Recent studies suggested that some salivary biomarkers are sensitive to sleep characteristics and thus, may allow the objective and easy evaluation of sleepiness.
The objective of the study is to explore the usability of salivary biomarkers (a-amylase and oxalate) as a new non-invasive technique to evaluate sleepiness and to diagnose primary hypersomnia in children.
The hypothesis of this study is that there will be a modification of salivary biomarkers concentrations with the variations of diurnal sleepiness.
Children hospitalized for an evaluation of their excessive diurnal sleepiness will be included in this study.
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.
Exclusion Criteria:
Children with primary hypersomnia, i.e. narcolepsy or idiopathic hypersomnia
Biological: saliva samples · Behavioral: Stanford sleepiness scale · Behavioral: Karolinska Sleepiness Scale · Behavioral: Epworth Sleepiness Scale · Behavioral: BLAST test
Children with a secondary hypersomnia, i.e. caused by sleep deprivation, a psychiatric disorder, sleep fragmentation, circadian delay.
Biological: saliva samples · Behavioral: Stanford sleepiness scale · Behavioral: Karolinska Sleepiness Scale · Behavioral: Epworth Sleepiness Scale · Behavioral: BLAST test
Collection of salivary a-amylase during the day (5 times a day: at 8:00 am, 9:00 am,1:00pm, 4:00pm and 8:00pm) with Salivette.
The Stanford Sleepiness Scale evaluates sleepiness at the time of the evaluation. The subjects have to choose the statement best representing their level of sleepiness on a scale ranging from 1 to 7: the higher the score, the higher the sleepiness. This scale will be submitted to the children before each salivary sampling (5 times a day: at 8:00 am, 9:00 am,1:00pm, 4:00pm and 8:00pm)
The Karolinska Sleepiness Scale assesses the perceived level of sleepiness at the time of the evaluation on a 9-points scale. The higher the score, the higher the sleepiness. This scale will be submitted to the children before each salivary sampling (5 times a day: at 8:00 am, 9:00 am,1:00pm, 4:00pm and 8:00pm)
The Adapted Epworth Sleepiness Scale for children in which the item "falling asleep while in a car stopped in traffic" was replaced by "falling asleep at school" assesses the risk of falling asleep in 8 daily-life situations estimated on a 4-point Likert scale. The total score is the sum of the scores for the 8 items: a higher score represents greater sleepiness and the pathological threshold is higher than 10. This scale will be submitted to the children one time, at the onset of the hospitalization.
The BLAST (Bron/Lyon Attention Stability Test) is a computerized attention test evaluating brief lapses of attention with 4 measures: reaction times, errors and two composite measures (Stability and Intensity). The subjects have to detect the presence or the absence of a specific stimulus during approximatively 60 trials for 3 minutes. Normative data are available for both children and adults. This test is part of the neuropsychological evaluation, conducted the afternoon of the first day of hospitalization. The test is realized at 4:00pm.
Salivary a-amylase concentration (U/ml)
Salivary a-amylase concentrations will be collected with Salivette. Children will be asked to passively keep a piece of cotton in mouth that will absorb the saliva for one minute.
Time frame: 3 days following the inclusion
Ran from Apr 2022 to primary completion in Nov 2024, 31 months.
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This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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