ClinicalTrials.gg
CompletedNCT06898008CEPSDEUpdated Mar 27, 2025

Characterization of Children with Complaints of Excessive Daytime Sleepiness

An observational study in Excessive Daytime Sleepiness, sponsored by Hospices Civils de Lyon. Completed at 1 site in France. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2025-03-27.

Sponsored by Hospices Civils de Lyon · Observational

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Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
400
Ages
Up to 18 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

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.

Started
2024
with 4 others
Observational
6 of 30
1 open now
Registered
26th of 30
by date
Lead sponsor
4 of 30
Hospices Civils de Lyon

Among the 30 studies in Disorders of Excessive Somnolence with a site in France, this one is one of 5 that started in 2024, is one of 6 observational ones, and was the 26th registered.

Disorders of Excessive Somnolence

196 studies on the registry are indexed under Disorders of Excessive Somnolence; 34 are open to participants now.

Browse Disorders of Excessive Somnolence studies →

Open to participants now

9 of the 30 studies in Disorders of Excessive Somnolence with a site in France are open now. Recruiting first, the newest first:

4 more — sign in →

All 9 open studies →

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 →

Who these studies take

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: Up to 18 Years · all sexes.

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02

Study summary

10% of the population suffers from excessive daytime sleepiness. This can be explained by a variety of etiologies: psychiatric disorders, altered sleep quantity or quality, hypersomnia... The consequences on quality of life are not negligible, with emotional, academic, social, financial and somatic repercussions. Diagnosing and managing them is essential. This is the role of the HFME's Child Sleep Service, a reference center for rare narcolepsy and hypersomnia, which carries out a weekly hypersomnia assessment. In this context, the investigators are carrying out a retrospective descriptive study, the primary objective of which is to describe the results and diagnoses of hypersomnia check-ups in the HFME's Sleep Department, in order to obtain feedback on the center's activity and its evolution.

The secondary objectives are to characterize the patients in the different diagnostic groups, to highlight factors associated with the different diagnoses, and to describe changes in patient characteristics over time.

03

Conditions studied

  • Excessive Daytime Sleepiness
04

Who can participate

Ages eligible
Up to 18 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

patients at the HFME university hospital center, third-line referral center for the Auvergne-Rhônes-Alpes region (France)

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.

Inclusion criteria

    • Patient hospitalized in the HFME sleep department for a "diagnostic assessment of hypersomnia".
  • Age under 18 at the time of hospitalization
  • From January 2015 to December 2023

Exclusion criteria

Exclusion Criteria:

    • No balance sheet
  • Age over 18 at time of hospitalization
  • Assessment for medicolegal or therapeutic adaptation purposes
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
400 participants (actual)
Patient registry
No

Groups and cohorts

  • patient < 18 years of age, having received a diagnostic evaluation for hypersomnia in the HFME sleep

    Other: Assessment of socio-demographic, anthropometric, psychometric and clinical characteristics

Interventions

  • OtherAssessment of socio-demographic, anthropometric, psychometric and clinical characteristics

    age, sex and place of residence, socioeconomic level, education, anthropometric data, first-degree family history, screen time, physical activity time, sleep time, comorbidity, drug treatments, education, total IQ, results of Epworth, CDI, ISI, ADHD, CONNERS, SCSC, Horne and Ostberg questionnaires, hearing aids, referring professional, melatonin dosage, ferritinemia, etiology of sleepiness

06

What researchers measure

Primary outcomes

  1. Describe the results and diagnoses of hypersomnia assessments in the HFME Sleep Department

    Time frame: Feedback consultation 1 month after inpatient assessment

07

Study locations

1 site
  • Service d'épileptologie clinique, des troubles du sommeil et de neurologie fonctionnelle de l'enfant - Hôpital Femme Mère Enfant
    France, Bron 69500, France
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2024 to primary completion in Jan 2024, 0 months.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 20, 2025
First posted
Mar 27, 2025
StartActual
Jan 1, 2024
Primary completionActual
Jan 5, 2024
CompletionActual
Oct 31, 2024
Last update
Mar 27, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 27, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06898008
Responsible party
Sponsor
First posted
Mar 27, 2025
Start date
Jan 1, 2024
Primary completion
Jan 5, 2024
Completion
Oct 31, 2024
Last update
Mar 27, 2025

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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