NCT06898008

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2024

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 5, 2024

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 20, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 27, 2025

Completed
Last Updated

March 27, 2025

Status Verified

March 1, 2025

Enrollment Period

4 days

First QC Date

March 20, 2025

Last Update Submit

March 20, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

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

    Feedback consultation 1 month after inpatient assessment

Study Arms (1)

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

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

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

Eligibility Criteria

AgeUp to 18 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • \- 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service d'épileptologie clinique, des troubles du sommeil et de neurologie fonctionnelle de l'enfant - Hôpital Femme Mère Enfant

France, Bron, 69500, France

Location

MeSH Terms

Conditions

Disorders of Excessive Somnolence

Interventions

Psychometrics

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

Psychological TestsBehavioral Disciplines and Activities

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2025

First Posted

March 27, 2025

Study Start

January 1, 2024

Primary Completion

January 5, 2024

Study Completion

October 31, 2024

Last Updated

March 27, 2025

Record last verified: 2025-03

Locations