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Sleep and Memory in Children (EnSOM)

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ClinicalTrials.gov Identifier: NCT02785328
Recruitment Status : Completed
First Posted : May 27, 2016
Last Update Posted : March 21, 2019
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

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.

Condition or disease Intervention/treatment Phase
Sleep Apnea Temporo-central Epilepsy Narcolepsy High Intellectual Potential Healthy Subject Other: memory evaluation at V1 and V2 (with treatment) Other: memory evaluation at V1 (without treatment) Other: memory evaluation at V1 and V2 (without treatment) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Sleep-dependent Memory Consolidation in Children With Sleep Diseases
Actual Study Start Date : February 2016
Actual Primary Completion Date : May 29, 2018
Actual Study Completion Date : May 29, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory

Arm Intervention/treatment
Experimental: obstructive sleep apnoea
The objective of this task is to evaluate the sleep-dependent consolidation abilities before and after treatment in children suffering from obstructive sleep apnoea syndrome.
Other: memory evaluation at V1 and V2 (with treatment)
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.

Experimental: narcolepsy
The objective of this task is to evaluate the sleep-dependent consolidation abilities before and after treatment in children suffering from narcolepsy.
Other: memory evaluation at V1 and V2 (with treatment)
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.

Experimental: BECTS (Benign epilepsy with centro-temporal spikes)
The objective of this task is to evaluate the sleep-dependent consolidation abilities before and after treatment in children suffering from BECTS.
Other: memory evaluation at V1 and V2 (with treatment)
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.

Experimental: high intellectual potential
The objective of this task is to evaluate the sleep-dependent consolidation abilities in children with high intellectual potential.
Other: memory evaluation at V1 (without treatment)
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.

Experimental: healthy children
The objective of this task is to evaluate the sleep-dependent consolidation abilities in healthy children.
Other: memory evaluation at V1 and V2 (without treatment)
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 Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02785328


Locations
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France
Service d'exploration et pathologie du sommeil, Hôpital Femme Mère Enfant, 59 Bd Pinel
Lyon, Auvergne-Rhône-Alpes, France, 69677
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Patricia FRANCO, MD PHD Service d'exploration et pathologie du sommeil Hôpital Femme Mère Enfant, 59 bd Pinel 69677 BRON Cedex

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02785328     History of Changes
Other Study ID Numbers: 69HCL15_0226
First Posted: May 27, 2016    Key Record Dates
Last Update Posted: March 21, 2019
Last Verified: March 2019
Keywords provided by Hospices Civils de Lyon:
Memory
sleep
narcolepsy
apnea
epilepsy
Additional relevant MeSH terms:
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Epilepsy
Narcolepsy
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Brain Diseases
Central Nervous System Diseases
Disorders of Excessive Somnolence
Mental Disorders