Excessive Daytime SleepinessCEPSDENCT06898008
Characterization of Children with Complaints of Excessive Daytime Sleepiness
An observational study of Excessive Daytime Sleepiness, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Excessive Daytime Sleepiness
- What is being tested?
- Assessment of socio-demographic, anthropometric, psychometric and clinical characteristics
- How many people
- 400 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2024to 31 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- Child, Adult
Study population: patients at the HFME university hospital center, third-line referral center for the Auvergne-Rhônes-Alpes region (France)
Who may be able to join
- - 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
Who cannot join
- - No balance sheet
- Age over 18 at time of hospitalization
- Assessment for medicolegal or therapeutic adaptation purposes
Trial locations and contacts
1 site in 1 country.
France1 site
Service d'épileptologie clinique, des troubles du sommeil et de neurologie fonctionnelle de l'enfant - Hôpital Femme Mère Enfant
France, Bron, 69500
About this study
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.
- Conditions
- Excessive Daytime Sleepiness
- Being tested
- Assessment of socio-demographic, anthropometric, psychometric and clinical characteristics
- Medical subject headings
- Disorders of Excessive Somnolence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of socio-demographic, anthropometric, psychometric and clinical characteristicsOther
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
| Study group | Role | What they receive |
|---|---|---|
| patient < 18 years of age, having received a diagnostic evaluation for hypersomnia in the HFME sleep | Not described Receives: Other: Assessment of socio-demographic, anthropometric, psychometric and clinical characteristics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Describe the results and diagnoses of hypersomnia assessments in the HFME Sleep Department
Measured: Feedback consultation 1 month after inpatient assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2025
- Study start1 Jan 2024
- Primary completion5 Jan 2024
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Excessive Daytime SleepinessStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06898008
- Sponsor's protocol ID
- 23-5430
- Acronym
- CEPSDE
- Status last verified
- Mar 2025
- First submitted
- 20 Mar 2025
- Last updated
- 27 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Children with Complaints of Excessive Daytime Sleepiness
- ClinicalTrials.gov ID
- NCT06898008
- Acronym / sponsor ID
- CEPSDE / 23-5430
- Conditions
- Excessive Daytime Sleepiness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 5 Jan 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 27 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- patients at the HFME university hospital center, third-line referral center for the Auvergne-Rhônes-Alpes region (France)
Key inclusion criteria (3 listed)
- - 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
Key exclusion criteria (3 listed)
- - No balance sheet
- Age over 18 at time of hospitalization
- Assessment for medicolegal or therapeutic adaptation purposes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assessment of socio-demographic, anthropometric, psychometric and clinical characteristicsage, 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 | Other | patient < 18 years of age, having received a diagnostic evaluation for hypersomnia in the HFME sleep |
Primary outcome
Describe the results and diagnoses of hypersomnia assessments in the HFME Sleep Department
Time frame: Feedback consultation 1 month after inpatient assessment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Excessive Daytime Sleepiness, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Describe the results and diagnoses of hypersomnia assessments in the HFME Sleep Department (time frame: Feedback consultation 1 month after inpatient assessment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2025.