Sleep Related Memory Consolidation in Children With Age Related Focal Epilepsy.
EPIMEM
1 other identifier
interventional
95
1 country
2
Brief Summary
Age related focal epilepsies in children encompasses, according to the ILAE criteria, benign epilepsy with centro temporal spikes (BECTS), atypical benign partial epilepsy (ABPE) and epileptic encephalopathy with continuous spike and waves during sleep (ECSWS). These non structural epilepsies are associated with interictal sleep spike and waves activated by sleep. Moreover, high prevalence of learning disorders occur in children with age related epilepsies. A correlation is suspected between learning disorders and sleep activation of spike and waves. The investigators suppose that learning dysfunction is linked to loss of information during sleep of epileptic children, unlike for control patients. As sleep allows memory consolidation of words learned during wakefulness, an epileptic activity during sleep may disrupt this consolidation, leading to a loss of information. Hypothesis: the investigators hypothesize a disruption of memory consolidation after one night in children affected with ABPE and ECSWS (severe group) compared to memory consolidation in children affected with BECTS (benign group), and control group. Primary purpose: To demonstrate that the deficit of delayed recall in 15 word learning test after one night is higher for the "severe group", compared to the "benign group" and the control group. Secondary purposes:
- to study the evolution over time of memory consolidation
- to evaluate the correlation of the deficit of delayed recall with executive dysfunction, clinical factors of epilepsy, neurophysiological factors of epilepsy, and sleep architecture
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2019
Longer than P75 for not_applicable
2 active sites
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
First Submitted
Initial submission to the registry
March 4, 2019
CompletedFirst Posted
Study publicly available on registry
March 7, 2019
CompletedStudy Start
First participant enrolled
March 27, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2027
December 5, 2025
November 1, 2025
8.4 years
March 4, 2019
November 28, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
memory lapse rate at 24 hours in the severe group, the benign group and the control group. ("memory lapse rate": rate of non recalled words number, during the delayed recall phase of the test, related to the maximal number of words recalled
24 hours
Secondary Outcomes (5)
memory lapse rate for each group
at 1 hour, 5 hours, 24 hours
Correlation of memory lapse rate with Executive functioning tests scores
at 1 hour, 5 hours, 24 hours
Correlation of memory lapse rate with age of onset, epilepsy phase, treatment
at 1 hour, 5 hours, 24 hours
Correlation of memory lapse rate with EEG severity scale, atypical criteria, EEG focus localization, sleep discharges frequency
at 1 hour, 5 hours, 24 hours
Correlation of memory lapse rate with number and organization of sleep cycles
at 1 hour, 5 hours, 24 hours
Study Arms (2)
EPILEPSY GROUP
EXPERIMENTALPatients with typical BECTS (benign group) or atypical BECTS or ECSWS (severe group) Medical visit Neuropsychological testing Neuropsychological procedure Video EEG and polysomnography (standard of care procedure): 2h wake and whole night Sleep diary
CONTROL GROUP
OTHERPatients hospitalized for non neurologic illness (diabetes, nephropathy, chronic intestinal disease) Medical visit Neuropsychological testing Neuropsychological procedure Video EEG and polysomnography : 2h wake and whole night Sleep diary
Interventions
memory, executive testing, behaviour questionnaire, visual attention,
Rey auditory verbal learning test, Delayed recall : 1h, 5h, 24h (after one night sleep)
Video EEG : 10 electrodes + 3 electrodes for PSG 2h wake EEG Whole night EEG
Eligibility Criteria
You may qualify if:
- Principal:
- normal psychomotor development
- informed consent signed by both parents and subject if able
- affiliated to social security regimen
- Specific
- Patients from "severe" and "benign" groups:
- focal age related epilepsy: BECTS, ABPE, ECSWS (ILAE criteria)
- children hospitalized for their follow-up
- normal neuroimaging
- Control group
- children hospitalized for a non neurologic disease
You may not qualify if:
- Principal:
- Psychiatric trouble (DSM V) Sensorial trouble without correction Poor command of French language Minor under care
- Specific
- Patients from "severe" and "benign" groups:
- degenerative disease
- abnormal neuroimaging
- mental deficiency
- Control group
- neurologic trouble
- abnormal sleep EEG
- intellectual deficiency
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Hopital D'Enfants Pediatrie Medicale Ambulatoire
Nancy, 54511, France
Hopital de Hautepierre-Service de Pediatrie/Neurologie
Strasbourg, 67098, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anne DE SAINT MARTIN, MD
Hôpitaux Universitaires de Strasbourg
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 4, 2019
First Posted
March 7, 2019
Study Start
March 27, 2019
Primary Completion (Estimated)
September 1, 2027
Study Completion (Estimated)
September 1, 2027
Last Updated
December 5, 2025
Record last verified: 2025-11