Sleep and Memory in Children
EnSOM
Sleep-dependent Memory Consolidation in Children With Sleep Diseases
1 other identifier
interventional
71
1 country
1
Brief Summary
Sleep exerts a dual effect on learning: on the one hand, good sleep quality allows good daytime aptitudes leading to knowledge acquisition. On the other hand, sleep after learning is necessary for knowledge consolidation. A key role of sleep has clearly been demonstrated in memory consolidation in adults. Sleep leads to strengthen memory by promoting brain plasticity. Surprisingly, sleep influence on learning stabilization has scarcely been studied during childhood and in children affected by sleep disorders. Yet, sleep disorders concern almost 30% of children and are frequently related to a worsening in academic performances. Classical neuropsychological evaluations of these children, based on daytime learning, often fail to determine cognitive profiles explaining their academic difficulties. The investigators hypothesize that a lack of sleep-dependent consolidation could take an active part in these children's cognitive and academic difficulties. This proposal aims at characterizing interactions between sleep, learning and memory processes that have not been studied in children of elementary school age (6-12 years). The investigators will evaluate sleep-dependent memory consolidation processes in children with sleep disorders before and after treatment and healthy controls. Neuropsychological testing and academic performances will be also evaluated.. The comparison of performances obtained before and after medical treatment, will allow to understand whether normalisation of sleep quality permits the restoration of sleep-dependent memory consolidation.
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 Feb 2016
Typical duration for not_applicable
1 active site
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
February 1, 2016
CompletedFirst Submitted
Initial submission to the registry
May 20, 2016
CompletedFirst Posted
Study publicly available on registry
May 27, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 29, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 29, 2018
CompletedMarch 21, 2019
March 1, 2019
2.3 years
May 20, 2016
March 19, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Memory performances
memory test : Björn Rasch, et al. (2007)
6 months
Memory performances
\- Mirror drawing test : Nissen, et al. (2006).
6 months
Memory performances
\- Word- pairs test : Urbain et al. (2011).
6 months
Memory performances
\- Emotional memory test : Prehn-Kristensen et al. (2009).
6 months
Secondary Outcomes (22)
total sleep time (TST)
3 months and 6 months
sleep efficiency (sleep time/time on bed)
3 months and 6 months
sleep latency (time before sleeping after closing eyes)
3 months and 6 months
number of awakenings
3 months and 6 months
number of Stage 1
3 months and 6 months
- +17 more secondary outcomes
Study Arms (5)
obstructive sleep apnoea
EXPERIMENTALThe objective of this task is to evaluate the sleep-dependent consolidation abilities before and after treatment in children suffering from obstructive sleep apnoea syndrome.
narcolepsy
EXPERIMENTALThe objective of this task is to evaluate the sleep-dependent consolidation abilities before and after treatment in children suffering from narcolepsy.
BECTS (Benign epilepsy with centro-temporal spikes)
EXPERIMENTALThe objective of this task is to evaluate the sleep-dependent consolidation abilities before and after treatment in children suffering from BECTS.
high intellectual potential
EXPERIMENTALThe objective of this task is to evaluate the sleep-dependent consolidation abilities in children with high intellectual potential.
healthy children
EXPERIMENTALThe objective of this task is to evaluate the sleep-dependent consolidation abilities in healthy children.
Interventions
Overnight episodic and procedural memory consolidation performance will be assessed at V1 and V2. The performance will be correlated with sleep data, diurnal neuropsychological assessment and academic performance. The children receive drug treatment (BECTS and Narcolepsy) or surgical (OSA) as part of their routine care.
Overnight episodic and procedural memory consolidation performance will be assessed at V1. The performance will be correlated with sleep data, diurnal neuropsychological assessment and academic performance.
Overnight episodic and procedural memory consolidation performance will be assessed at V1 and V2. The performance will be correlated with sleep data, diurnal neuropsychological assessment and academic performance.
Eligibility Criteria
You may qualify if:
- aged between 6 and 12 y
- referred to the HFME for a suspicion of sleep apnea
- narcolepsy
- centro-temporal epilepsy
- high intellectual potential
- children without sleep disorders will be included in the healthy control group.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Service d'exploration et pathologie du sommeil, Hôpital Femme Mère Enfant, 59 Bd Pinel
Lyon, Auvergne-Rhône-Alpes, 69677, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Patricia FRANCO, MD PHD
Service d'exploration et pathologie du sommeil Hôpital Femme Mère Enfant, 59 bd Pinel 69677 BRON Cedex
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 20, 2016
First Posted
May 27, 2016
Study Start
February 1, 2016
Primary Completion
May 29, 2018
Study Completion
May 29, 2018
Last Updated
March 21, 2019
Record last verified: 2019-03