- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06898008
Characterization of Children with Complaints of Excessive Daytime Sleepiness (CEPSDE)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Bron
-
France, Bron, France, 69500
- Service d'Epileptologie Clinique, des Troubles du sommeil et de Neurologie fonctionnelle de l'enfant - Hôpital Femme Mère Enfant
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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:
- - No balance sheet
- Age over 18 at time of hospitalization
- Assessment for medicolegal or therapeutic adaptation purposes
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
patient < 18 years of age, having received a diagnostic evaluation for hypersomnia in the HFME sleep
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Describe the results and diagnoses of hypersomnia assessments in the HFME Sleep Department
Time Frame: Feedback consultation 1 month after inpatient assessment
|
Feedback consultation 1 month after inpatient assessment
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 23-5430
Drug and device information, study documents
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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