NCT06967935

Brief Summary

Memory consolidation transforms unstable memory traces into lasting representations, a process enhanced by both sleep and rehearsal during learning. Rehearsal is thought to accelerate consolidation by inducing memory reactivations that resemble those occurring during sleep. However, the respective mechanisms of sleep- and rehearsal-induced consolidation-and their potential interactions-remain poorly understood, especially in patients with temporal lobe epilepsy, where rehearsal might help compensate for memory deficits linked to hippocampal dysfunction, and where sleep may exacerbate epileptic activity. The CORESOM-EPI study aims to compare the effects of rehearsal and sleep on memory consolidation in patients undergoing video-EEG monitoring. Participants will learn "object-place" associations under two conditions (single versus repeated encoding), with memory tested immediately and again after a 12-hour delay. This delay will either include a full day awake or a night of sleep, allowing direct comparison of sleep- and rehearsal-related consolidation effects. Each participant will perform the task twice, with "wake" and "sleep" condition, in a balanced order. As a preliminary phase of the CRIMES study (ANR-DFG 2024), CORESOM-EPI will help assess how sleep and rehearsal influence memory consolidation in epilepsy. It will also serve to adapt the behavioral task for clinical use, paving the way for a future intracranial EEG investigations that will explore the neural networks involved and their modulation by epileptic activity.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
2mo left

Started Jun 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress85%
Jun 2025Jul 2026

First Submitted

Initial submission to the registry

May 5, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 13, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

June 30, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

July 8, 2025

Status Verified

July 1, 2025

Enrollment Period

1 year

First QC Date

May 5, 2025

Last Update Submit

July 7, 2025

Conditions

Keywords

EpilepsyMemory consolidationSleepReharsalReactivation

Outcome Measures

Primary Outcomes (4)

  • Change in the percentage of object categories recalled (vs. not recalled) between immediate (30 min after learning) and delayed (12h after learning) recall for rehearsed versus non-rehearsed items.

    The impact of rehearsal on object category recognition in an object-place learning paradigm is assessed. For the primary outcome, data from the 2 conditions ("wake" and "sleep" during the 12h period between immediate and delayed recall) will be pooled. Each participant will take part in the wake and sleep condition over 4 days (2 conditions separated by at least 24h), in a balanced order between participants.

    Day 2

  • Change in the percentage of object categories recalled (vs. not recalled) between immediate (30 min after learning) and delayed (12h after learning) recall for rehearsed versus non-rehearsed items.

    The impact of rehearsal on object category recognition in an object-place learning paradigm is assessed. For the primary outcome, data from the 2 conditions ("wake" and "sleep" during the 12h period between immediate and delayed recall) will be pooled. Each participant will take part in the wake and sleep condition over 4 days (2 conditions separated by at least 24h), in a balanced order between participants.

    Day 2 + 12 hours

  • Change in the percentage of object categories recalled (vs. not recalled) between immediate (30 min after learning) and delayed (12h after learning) recall for rehearsed versus non-rehearsed items.

    The impact of rehearsal on object category recognition in an object-place learning paradigm is assessed. For the primary outcome, data from the 2 conditions ("wake" and "sleep" during the 12h period between immediate and delayed recall) will be pooled. Each participant will take part in the wake and sleep condition over 4 days (2 conditions separated by at least 24h), in a balanced order between participants.

    Day 2 + 36 hours

  • Change in the percentage of object categories recalled (vs. not recalled) between immediate (30 min after learning) and delayed (12h after learning) recall for rehearsed versus non-rehearsed items.

    The impact of rehearsal on object category recognition in an object-place learning paradigm is assessed. For the primary outcome, data from the 2 conditions ("wake" and "sleep" during the 12h period between immediate and delayed recall) will be pooled. Each participant will take part in the wake and sleep condition over 4 days (2 conditions separated by at least 24h), in a balanced order between participants.

    Day 2 + 48 hours

Study Arms (2)

WAKE - SLEEP

This group will start with the condition 1 " wake " (encoding+immediate recall in the morning (8 :00am) and delayed recall in the evening (8 :00pm)) and will end with the condition 2 " sleep " : (encoding+immediate recall in the evening (8 :00pm) and delayed recall in the morning (8 :00am))

Other: Cognitive memory task on a computerOther: Eye trackingOther: Questionnaires on task-related fatigueOther: Questionnaire on task difficultyOther: Karolinska scale

SLEEP-WAKE

This group will start with the condition 2 " sleep "and will end with the condition 1 " wake "

Other: Cognitive memory task on a computerOther: Eye trackingOther: Questionnaires on task-related fatigueOther: Questionnaire on task difficultyOther: Karolinska scale

Interventions

Encoding: (1) Participants will learn 60 associations between pairs of items (cue and target) that are presented sequentially at unique locations on a screen, in a given context. 30 pairs are presented once, and 30 pairs are presented repeatedly (4 times). (2) After learning, the first recall phase begins after a short delay of 30 minutes: 50% of the pairs are tested in a similar way, this time with an assessment of contextual memory. (3) The remaining 50% of pairs are tested after a 12-hour delay, involving either a day awake (condition 1) or a night asleep (condition 2).

SLEEP-WAKEWAKE - SLEEP

Eye-tracking will be carried out during the task to ensure that participants are focused on the task (quantification of the number and duration of eye fixations in the area of interest corresponding to the target presentation)

SLEEP-WAKEWAKE - SLEEP

Questionnaire on task-related fatigue (Likert-scale) will be completed by participants between blocks of items during the task

SLEEP-WAKEWAKE - SLEEP

Questionnaires on task difficulty (Likert-scale) will be completed by participants at the end of the task

SLEEP-WAKEWAKE - SLEEP

Participants' state of sleepiness will be assessed at the beginning of each stage (encoding, immediate recall, delayed recall) using the Karolinska sleepiness scale

SLEEP-WAKEWAKE - SLEEP

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with epilepsy admitted to the Functional Neurology and Epileptology Department of the Hospices Civils de Lyon (University Hospital) for video-EEG monitoring will be invited by the investigating physician to participate in the study. If patients wish to take part, they will be asked to perform a cognitive task.

You may qualify if:

  • Patient with epilepsy (any type of epilepsy)
  • Hospitalized for video-EEG recording lasting at least 4 days
  • Aged 18-65 years

You may not qualify if:

  • Major cognitive impairment other than memory deficit
  • Refusal to participate
  • Pregnant women, women in labor or nursing mothers
  • Persons deprived of their liberty by judicial or administrative decision
  • Persons under psychiatric care
  • Persons admitted to a health or social institution for purposes other than research
  • Adults under legal protection (guardianship, curatorship)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de neurologie fonctionnelle et d'épileptologie, Hôpital neurologique Pierre Wertheimer

Bron, 69500, France

RECRUITING

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Central Study Contacts

Laure PETER-DEREX, Professor

CONTACT

Sylvain Rheims, Professor

CONTACT

Study Design

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

Study Record Dates

First Submitted

May 5, 2025

First Posted

May 13, 2025

Study Start

June 30, 2025

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

July 8, 2025

Record last verified: 2025-07

Locations