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Completed

NCT Number: NCT02785328

Sleep and Memory in Children

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.

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Key information

Conditions

Sleep Apnea Apnea Brain Diseases Central Nervous System Diseases Disorders of Excessive Somnolence Dyssomnias Epilepsy Healthy Subject High Intellectual Potential Mental Disorders Narcolepsy Nervous System Diseases Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders Temporo-central Epilepsy

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Service d'exploration et pathologie du sommeil, Hôpital Femme Mère Enfant, 59 Bd Pinel

Lyon, Auvergne-Rhône-Alpes, 69677, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

memory evaluation at V1 and V2 (with treatment)

Other

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.

memory evaluation at V1 (without treatment)

Other

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.

memory evaluation at V1 and V2 (without treatment)

Other

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.

Primary outcomes

  1. Memory performances

    Time frame: 6 months

    memory test : Björn Rasch, et al. (2007)

  2. Memory performances

    Time frame: 6 months

    • Mirror drawing test : Nissen, et al. (2006).

  3. Memory performances

    Time frame: 6 months

    • Word- pairs test : Urbain et al. (2011).

  4. Memory performances

    Time frame: 6 months

    • Emotional memory test : Prehn-Kristensen et al. (2009).

Secondary outcomes

  1. total sleep time (TST)

    Time frame: 3 months and 6 months

    standard full-night polysomnographic recording following the American Academy of Sleep Medicine recommendation will be performed at the hospital for the children suffering from sleep diseases (Morpheus, Medatec, Belgium) or at home for the healthy subjects (Dream, Medatec, Belgium). It will include electroencephalogram, electrooculogram, electromyogram, and electrocardiogram.

  2. sleep efficiency (sleep time/time on bed)

    Time frame: 3 months and 6 months

    standard full-night polysomnographic recording following the American Academy of Sleep Medicine recommendation will be performed at the hospital for the children suffering from sleep diseases (Morpheus, Medatec, Belgium) or at home for the healthy subjects (Dream, Medatec, Belgium). It will include electroencephalogram, electrooculogram, electromyogram, and electrocardiogram.

  3. sleep latency (time before sleeping after closing eyes)

    Time frame: 3 months and 6 months

    standard full-night polysomnographic recording following the American Academy of Sleep Medicine recommendation will be performed at the hospital for the children suffering from sleep diseases (Morpheus, Medatec, Belgium) or at home for the healthy subjects (Dream, Medatec, Belgium). It will include electroencephalogram, electrooculogram, electromyogram, and electrocardiogram.

  4. number of awakenings

    Time frame: 3 months and 6 months

    standard full-night polysomnographic recording following the American Academy of Sleep Medicine recommendation will be performed at the hospital for the children suffering from sleep diseases (Morpheus, Medatec, Belgium) or at home for the healthy subjects (Dream, Medatec, Belgium). It will include electroencephalogram, electrooculogram, electromyogram, and electrocardiogram.

  5. number of Stage 1

    Time frame: 3 months and 6 months

    standard full-night polysomnographic recording following the American Academy of Sleep Medicine recommendation will be performed at the hospital for the children suffering from sleep diseases (Morpheus, Medatec, Belgium) or at home for the healthy subjects (Dream, Medatec, Belgium). It will include electroencephalogram, electrooculogram, electromyogram, and electrocardiogram.

  6. number of Stage 2

    Time frame: 3 months and 6 months

    standard full-night polysomnographic recording following the American Academy of Sleep Medicine recommendation will be performed at the hospital for the children suffering from sleep diseases (Morpheus, Medatec, Belgium) or at home for the healthy subjects (Dream, Medatec, Belgium). It will include electroencephalogram, electrooculogram, electromyogram, and electrocardiogram.

  7. Slow-wave sleep (SWS) percentages

    Time frame: 3 months and 6 months

    standard full-night polysomnographic recording following the American Academy of Sleep Medicine recommendation will be performed at the hospital for the children suffering from sleep diseases (Morpheus, Medatec, Belgium) or at home for the healthy subjects (Dream, Medatec, Belgium). It will include electroencephalogram, electrooculogram, electromyogram, and electrocardiogram.

  8. PS percentages

    Time frame: 3 months and 6 months

    standard full-night polysomnographic recording following the American Academy of Sleep Medicine recommendation will be performed at the hospital for the children suffering from sleep diseases (Morpheus, Medatec, Belgium) or at home for the healthy subjects (Dream, Medatec, Belgium). It will include electroencephalogram, electrooculogram, electromyogram, and electrocardiogram.

  9. SWS time

    Time frame: 3 months and 6 months

    standard full-night polysomnographic recording following the American Academy of Sleep Medicine recommendation will be performed at the hospital for the children suffering from sleep diseases (Morpheus, Medatec, Belgium) or at home for the healthy subjects (Dream, Medatec, Belgium). It will include electroencephalogram, electrooculogram, electromyogram, and electrocardiogram.

  10. PS latency (time between start of sleep and start of PS)

    Time frame: 3 months and 6 months

    standard full-night polysomnographic recording following the American Academy of Sleep Medicine recommendation will be performed at the hospital for the children suffering from sleep diseases (Morpheus, Medatec, Belgium) or at home for the healthy subjects (Dream, Medatec, Belgium). It will include electroencephalogram, electrooculogram, electromyogram, and electrocardiogram.

  11. numbers of rapid eye movements

    Time frame: 3 months and 6 months

    standard full-night polysomnographic recording following the American Academy of Sleep Medicine recommendation will be performed at the hospital for the children suffering from sleep diseases (Morpheus, Medatec, Belgium) or at home for the healthy subjects (Dream, Medatec, Belgium). It will include electroencephalogram, electrooculogram, electromyogram, and electrocardiogram.

  12. total cycle time (TCT)

    Time frame: 3 months and 6 months

    standard full-night polysomnographic recording following the American Academy of Sleep Medicine recommendation will be performed at the hospital for the children suffering from sleep diseases (Morpheus, Medatec, Belgium) or at home for the healthy subjects (Dream, Medatec, Belgium). It will include electroencephalogram, electrooculogram, electromyogram, and electrocardiogram.

  13. TCT/TST ratio

    Time frame: 3 months and 6 months

    standard full-night polysomnographic recording following the American Academy of Sleep Medicine recommendation will be performed at the hospital for the children suffering from sleep diseases (Morpheus, Medatec, Belgium) or at home for the healthy subjects (Dream, Medatec, Belgium). It will include electroencephalogram, electrooculogram, electromyogram, and electrocardiogram.

  14. WASO (wake after sleep onset)

    Time frame: 3 months and 6 months

    standard full-night polysomnographic recording following the American Academy of Sleep Medicine recommendation will be performed at the hospital for the children suffering from sleep diseases (Morpheus, Medatec, Belgium) or at home for the healthy subjects (Dream, Medatec, Belgium). It will include electroencephalogram, electrooculogram, electromyogram, and electrocardiogram.

  15. apnoea/hypopnoea index

    Time frame: 3 months and 6 months

    standard full-night polysomnographic recording following the American Academy of Sleep Medicine recommendation will be performed at the hospital for the children suffering from sleep diseases (Morpheus, Medatec, Belgium) or at home for the healthy subjects (Dream, Medatec, Belgium). It will include electroencephalogram, electrooculogram, electromyogram, and electrocardiogram.

  16. O2 desaturation

    Time frame: 3 months and 6 months

    standard full-night polysomnographic recording following the American Academy of Sleep Medicine recommendation will be performed at the hospital for the children suffering from sleep diseases (Morpheus, Medatec, Belgium) or at home for the healthy subjects (Dream, Medatec, Belgium). It will include electroencephalogram, electrooculogram, electromyogram, and electrocardiogram.

  17. micro-arousal index

    Time frame: 3 months and 6 months

    standard full-night polysomnographic recording following the American Academy of Sleep Medicine recommendation will be performed at the hospital for the children suffering from sleep diseases (Morpheus, Medatec, Belgium) or at home for the healthy subjects (Dream, Medatec, Belgium). It will include electroencephalogram, electrooculogram, electromyogram, and electrocardiogram.

  18. attention assessment

    Time frame: 3 months and 6 months

    Neuropsychological assessment will be standardized

  19. short and long term memory

    Time frame: 3 months and 6 months

    Neuropsychological assessment will be standardized

  20. executive functions

    Time frame: 3 months and 6 months

    Neuropsychological assessment will be standardized

  21. depression and anxiety

    Time frame: 3 months and 6 months

    Neuropsychological assessment will be standardized

  22. Intellectual Quotient

    Time frame: 3 months and 6 months

    Neuropsychological assessment will be standardized

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Sleep-dependent Memory Consolidation in Children With Sleep Diseases

Acronym: EnSOM

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
May 27, 2016
Registry last updated
Mar 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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