NCT02785328

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 20, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 27, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 29, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 29, 2018

Completed
Last Updated

March 21, 2019

Status Verified

March 1, 2019

Enrollment Period

2.3 years

First QC Date

May 20, 2016

Last Update Submit

March 19, 2019

Conditions

Keywords

Memorysleepnarcolepsyapneaepilepsy

Outcome Measures

Primary Outcomes (4)

  • Memory performances

    memory test : Björn Rasch, et al. (2007)

    6 months

  • Memory performances

    \- Mirror drawing test : Nissen, et al. (2006).

    6 months

  • Memory performances

    \- Word- pairs test : Urbain et al. (2011).

    6 months

  • Memory performances

    \- Emotional memory test : Prehn-Kristensen et al. (2009).

    6 months

Secondary Outcomes (22)

  • total sleep time (TST)

    3 months and 6 months

  • sleep efficiency (sleep time/time on bed)

    3 months and 6 months

  • sleep latency (time before sleeping after closing eyes)

    3 months and 6 months

  • number of awakenings

    3 months and 6 months

  • number of Stage 1

    3 months and 6 months

  • +17 more secondary outcomes

Study Arms (5)

obstructive sleep apnoea

EXPERIMENTAL

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)

narcolepsy

EXPERIMENTAL

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)

BECTS (Benign epilepsy with centro-temporal spikes)

EXPERIMENTAL

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)

high intellectual potential

EXPERIMENTAL

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)

healthy children

EXPERIMENTAL

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)

Interventions

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.

BECTS (Benign epilepsy with centro-temporal spikes)narcolepsyobstructive sleep apnoea

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.

high intellectual potential

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.

healthy children

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Lyon, Auvergne-Rhône-Alpes, 69677, France

Location

MeSH Terms

Conditions

Sleep Apnea SyndromesNarcolepsyApneaEpilepsy

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesDisorders of Excessive SomnolenceMental DisordersSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsBrain DiseasesCentral Nervous System Diseases

Study Officials

  • Patricia FRANCO, MD PHD

    Service d'exploration et pathologie du sommeil Hôpital Femme Mère Enfant, 59 bd Pinel 69677 BRON Cedex

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2016

First Posted

May 27, 2016

Study Start

February 1, 2016

Primary Completion

May 29, 2018

Study Completion

May 29, 2018

Last Updated

March 21, 2019

Record last verified: 2019-03

Locations