Clinical trial NCT02785328: Sleep and Memory in Children
Official title: Sleep-dependent Memory Consolidation in Children With Sleep Diseases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Apnea
Temporo-central Epilepsy
Narcolepsy
High Intellectual Potential
Healthy Subject
Keywords: Memory
sleep
narcolepsy
apnea
epilepsy
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-05-27
Enrollment: 71
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Primary outcomes:
measure: Memory performances
timeFrame: 6 months
measure: Memory performances
timeFrame: 6 months
measure: Memory performances
timeFrame: 6 months
measure: Memory performances
timeFrame: 6 months
Secondary outcomes:
measure: total sleep time (TST)
timeFrame: 3 months and 6 months
measure: sleep efficiency (sleep time/time on bed)
timeFrame: 3 months and 6 months
measure: sleep latency (time before sleeping after closing eyes)
timeFrame: 3 months and 6 months
measure: number of awakenings
timeFrame: 3 months and 6 months
measure: number of Stage 1
timeFrame: 3 months and 6 months
measure: number of Stage 2
timeFrame: 3 months and 6 months
measure: Slow-wave sleep (SWS) percentages
timeFrame: 3 months and 6 months
measure: PS percentages
timeFrame: 3 months and 6 months
measure: SWS time
timeFrame: 3 months and 6 months
measure: PS latency (time between start of sleep and start of PS)
timeFrame: 3 months and 6 months
measure: numbers of rapid eye movements
timeFrame: 3 months and 6 months
measure: total cycle time (TCT)
timeFrame: 3 months and 6 months
measure: TCT/TST ratio
timeFrame: 3 months and 6 months
measure: WASO (wake after sleep onset)
timeFrame: 3 months and 6 months
measure: apnoea/hypopnoea index
timeFrame: 3 months and 6 months
measure: O2 desaturation
timeFrame: 3 months and 6 months
measure: micro-arousal index
timeFrame: 3 months and 6 months
measure: attention assessment
timeFrame: 3 months and 6 months
measure: short and long term memory
timeFrame: 3 months and 6 months
measure: executive functions
timeFrame: 3 months and 6 months
measure: depression and anxiety
timeFrame: 3 months and 6 months
measure: Intellectual Quotient
timeFrame: 3 months and 6 months
Other outcomes:
Locations:
city: Lyon
country: France
facility: Service d'exploration et pathologie du sommeil, Hôpital Femme Mère Enfant, 59 Bd Pinel
state: Auvergne-Rhône-Alpes
Study officials:
affiliation: Service d'exploration et pathologie du sommeil Hôpital Femme Mère Enfant, 59 bd Pinel 69677 BRON Cedex
name: Patricia FRANCO, MD PHD
role: PRINCIPAL_INVESTIGATOR
References: