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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
71

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • France
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospices Civils de Lyon

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 29, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 29, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 20, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 24, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 27, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 21, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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