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Sleep and Memory in Children (EnSOM)

Primary Purpose

Sleep Apnea, Temporo-central Epilepsy, Narcolepsy

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
memory evaluation at V1 and V2 (with treatment)
memory evaluation at V1 (without treatment)
memory evaluation at V1 and V2 (without treatment)
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Sleep Apnea focused on measuring Memory, sleep, narcolepsy, apnea, epilepsy

Eligibility Criteria

6 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

obstructive sleep apnoea

narcolepsy

BECTS (Benign epilepsy with centro-temporal spikes)

high intellectual potential

healthy children

Arm Description

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.

The objective of this task is to evaluate the sleep-dependent consolidation abilities before and after treatment in children suffering from narcolepsy.

The objective of this task is to evaluate the sleep-dependent consolidation abilities before and after treatment in children suffering from BECTS.

The objective of this task is to evaluate the sleep-dependent consolidation abilities in children with high intellectual potential.

The objective of this task is to evaluate the sleep-dependent consolidation abilities in healthy children.

Outcomes

Primary Outcome Measures

Memory performances
memory test : Björn Rasch, et al. (2007)
Memory performances
- Mirror drawing test : Nissen, et al. (2006).
Memory performances
- Word- pairs test : Urbain et al. (2011).
Memory performances
- Emotional memory test : Prehn-Kristensen et al. (2009).

Secondary Outcome Measures

total sleep time (TST)
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.
sleep efficiency (sleep time/time on bed)
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.
sleep latency (time before sleeping after closing eyes)
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.
number of awakenings
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.
number of Stage 1
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.
number of Stage 2
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.
Slow-wave sleep (SWS) percentages
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.
PS percentages
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.
SWS time
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.
PS latency (time between start of sleep and start of PS)
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.
numbers of rapid eye movements
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.
total cycle time (TCT)
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.
TCT/TST ratio
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.
WASO (wake after sleep onset)
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.
apnoea/hypopnoea index
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.
O2 desaturation
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.
micro-arousal index
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.
attention assessment
Neuropsychological assessment will be standardized
short and long term memory
Neuropsychological assessment will be standardized
executive functions
Neuropsychological assessment will be standardized
depression and anxiety
Neuropsychological assessment will be standardized
Intellectual Quotient
Neuropsychological assessment will be standardized

Full Information

First Posted
May 20, 2016
Last Updated
March 19, 2019
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT02785328
Brief Title
Sleep and Memory in Children
Acronym
EnSOM
Official Title
Sleep-dependent Memory Consolidation in Children With Sleep Diseases
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
February 2016 (Actual)
Primary Completion Date
May 29, 2018 (Actual)
Study Completion Date
May 29, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea, Temporo-central Epilepsy, Narcolepsy, High Intellectual Potential, Healthy Subject
Keywords
Memory, sleep, narcolepsy, apnea, epilepsy

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
71 (Actual)

8. Arms, Groups, and Interventions

Arm Title
obstructive sleep apnoea
Arm Type
Experimental
Arm Description
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.
Arm Title
narcolepsy
Arm Type
Experimental
Arm Description
The objective of this task is to evaluate the sleep-dependent consolidation abilities before and after treatment in children suffering from narcolepsy.
Arm Title
BECTS (Benign epilepsy with centro-temporal spikes)
Arm Type
Experimental
Arm Description
The objective of this task is to evaluate the sleep-dependent consolidation abilities before and after treatment in children suffering from BECTS.
Arm Title
high intellectual potential
Arm Type
Experimental
Arm Description
The objective of this task is to evaluate the sleep-dependent consolidation abilities in children with high intellectual potential.
Arm Title
healthy children
Arm Type
Experimental
Arm Description
The objective of this task is to evaluate the sleep-dependent consolidation abilities in healthy children.
Intervention Type
Other
Intervention Name(s)
memory evaluation at V1 and V2 (with treatment)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
memory evaluation at V1 (without treatment)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
memory evaluation at V1 and V2 (without treatment)
Intervention Description
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 Measure Information:
Title
Memory performances
Description
memory test : Björn Rasch, et al. (2007)
Time Frame
6 months
Title
Memory performances
Description
- Mirror drawing test : Nissen, et al. (2006).
Time Frame
6 months
Title
Memory performances
Description
- Word- pairs test : Urbain et al. (2011).
Time Frame
6 months
Title
Memory performances
Description
- Emotional memory test : Prehn-Kristensen et al. (2009).
Time Frame
6 months
Secondary Outcome Measure Information:
Title
total sleep time (TST)
Description
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.
Time Frame
3 months and 6 months
Title
sleep efficiency (sleep time/time on bed)
Description
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.
Time Frame
3 months and 6 months
Title
sleep latency (time before sleeping after closing eyes)
Description
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.
Time Frame
3 months and 6 months
Title
number of awakenings
Description
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.
Time Frame
3 months and 6 months
Title
number of Stage 1
Description
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.
Time Frame
3 months and 6 months
Title
number of Stage 2
Description
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.
Time Frame
3 months and 6 months
Title
Slow-wave sleep (SWS) percentages
Description
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.
Time Frame
3 months and 6 months
Title
PS percentages
Description
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.
Time Frame
3 months and 6 months
Title
SWS time
Description
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.
Time Frame
3 months and 6 months
Title
PS latency (time between start of sleep and start of PS)
Description
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.
Time Frame
3 months and 6 months
Title
numbers of rapid eye movements
Description
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.
Time Frame
3 months and 6 months
Title
total cycle time (TCT)
Description
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.
Time Frame
3 months and 6 months
Title
TCT/TST ratio
Description
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.
Time Frame
3 months and 6 months
Title
WASO (wake after sleep onset)
Description
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.
Time Frame
3 months and 6 months
Title
apnoea/hypopnoea index
Description
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.
Time Frame
3 months and 6 months
Title
O2 desaturation
Description
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.
Time Frame
3 months and 6 months
Title
micro-arousal index
Description
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.
Time Frame
3 months and 6 months
Title
attention assessment
Description
Neuropsychological assessment will be standardized
Time Frame
3 months and 6 months
Title
short and long term memory
Description
Neuropsychological assessment will be standardized
Time Frame
3 months and 6 months
Title
executive functions
Description
Neuropsychological assessment will be standardized
Time Frame
3 months and 6 months
Title
depression and anxiety
Description
Neuropsychological assessment will be standardized
Time Frame
3 months and 6 months
Title
Intellectual Quotient
Description
Neuropsychological assessment will be standardized
Time Frame
3 months and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patricia FRANCO, MD PHD
Organizational Affiliation
Service d'exploration et pathologie du sommeil Hôpital Femme Mère Enfant, 59 bd Pinel 69677 BRON Cedex
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service d'exploration et pathologie du sommeil, Hôpital Femme Mère Enfant, 59 Bd Pinel
City
Lyon
State/Province
Auvergne-Rhône-Alpes
ZIP/Postal Code
69677
Country
France

12. IPD Sharing Statement

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Sleep and Memory in Children

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