- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02785328
Sleep and Memory in Children (EnSOM)
March 19, 2019 updated by: Hospices Civils de Lyon
Sleep-dependent Memory Consolidation in Children With Sleep Diseases
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
71
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Auvergne-Rhône-Alpes
-
Lyon, Auvergne-Rhône-Alpes, France, 69677
- Service d'exploration et pathologie du sommeil, Hôpital Femme Mère Enfant, 59 Bd Pinel
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 12 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Memory performances
Time Frame: 6 months
|
memory test : Björn Rasch, et al. (2007)
|
6 months
|
Memory performances
Time Frame: 6 months
|
- Mirror drawing test : Nissen, et al. (2006).
|
6 months
|
Memory performances
Time Frame: 6 months
|
- Word- pairs test : Urbain et al. (2011).
|
6 months
|
Memory performances
Time Frame: 6 months
|
- Emotional memory test : Prehn-Kristensen et al. (2009).
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
3 months and 6 months
|
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 months and 6 months
|
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.
|
3 months and 6 months
|
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.
|
3 months and 6 months
|
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.
|
3 months and 6 months
|
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.
|
3 months and 6 months
|
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.
|
3 months and 6 months
|
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.
|
3 months and 6 months
|
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.
|
3 months and 6 months
|
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.
|
3 months and 6 months
|
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.
|
3 months and 6 months
|
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.
|
3 months and 6 months
|
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.
|
3 months and 6 months
|
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.
|
3 months and 6 months
|
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.
|
3 months and 6 months
|
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.
|
3 months and 6 months
|
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.
|
3 months and 6 months
|
attention assessment
Time Frame: 3 months and 6 months
|
Neuropsychological assessment will be standardized
|
3 months and 6 months
|
short and long term memory
Time Frame: 3 months and 6 months
|
Neuropsychological assessment will be standardized
|
3 months and 6 months
|
executive functions
Time Frame: 3 months and 6 months
|
Neuropsychological assessment will be standardized
|
3 months and 6 months
|
depression and anxiety
Time Frame: 3 months and 6 months
|
Neuropsychological assessment will be standardized
|
3 months and 6 months
|
Intellectual Quotient
Time Frame: 3 months and 6 months
|
Neuropsychological assessment will be standardized
|
3 months and 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Patricia FRANCO, MD PHD, Service d'exploration et pathologie du sommeil Hôpital Femme Mère Enfant, 59 bd Pinel 69677 BRON Cedex
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2016
Primary Completion (Actual)
May 29, 2018
Study Completion (Actual)
May 29, 2018
Study Registration Dates
First Submitted
May 20, 2016
First Submitted That Met QC Criteria
May 24, 2016
First Posted (Estimate)
May 27, 2016
Study Record Updates
Last Update Posted (Actual)
March 21, 2019
Last Update Submitted That Met QC Criteria
March 19, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 69HCL15_0226
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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