Sleep and Memory in Children

Sleep Apnea Clinical Trial

— EnSOM  

Official title:

Sleep-dependent Memory Consolidation in Children With Sleep Diseases

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02785328
• Other study ID #: 69HCL15_0226
• Status: Completed
• Phase: N/A
• Start date: February 2016
• Est. completion date: May 29, 2018

Study information

• Verified date: March 2019
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: May 29, 2018
• Est. primary completion date: May 29, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Epilepsy
• Healthy Subject
• High Intellectual Potential
• Narcolepsy
• Sleep Apnea
• Temporo-central Epilepsy

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
France	Service d'exploration et pathologie du sommeil, Hôpital Femme Mère Enfant, 59 Bd Pinel	Lyon	Auvergne-Rhône-Alpes

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Memory performances	memory test : Björn Rasch, et al. (2007)	6 months
Primary	Memory performances	- Mirror drawing test : Nissen, et al. (2006).	6 months
Primary	Memory performances	- Word- pairs test : Urbain et al. (2011).	6 months
Primary	Memory performances	- Emotional memory test : Prehn-Kristensen et al. (2009).	6 months
Secondary	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.	3 months and 6 months
Secondary	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.	3 months and 6 months
Secondary	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.	3 months and 6 months
Secondary	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.	3 months and 6 months
Secondary	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.	3 months and 6 months
Secondary	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.	3 months and 6 months
Secondary	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.	3 months and 6 months
Secondary	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.	3 months and 6 months
Secondary	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.	3 months and 6 months
Secondary	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.	3 months and 6 months
Secondary	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.	3 months and 6 months
Secondary	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.	3 months and 6 months
Secondary	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.	3 months and 6 months
Secondary	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.	3 months and 6 months
Secondary	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.	3 months and 6 months
Secondary	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.	3 months and 6 months
Secondary	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.	3 months and 6 months
Secondary	attention assessment	Neuropsychological assessment will be standardized	3 months and 6 months
Secondary	short and long term memory	Neuropsychological assessment will be standardized	3 months and 6 months
Secondary	executive functions	Neuropsychological assessment will be standardized	3 months and 6 months
Secondary	depression and anxiety	Neuropsychological assessment will be standardized	3 months and 6 months
Secondary	Intellectual Quotient	Neuropsychological assessment will be standardized	3 months and 6 months