Sleep ApneaEnSOMNCT02785328
Sleep and Memory in Children
A study testing memory evaluation at V1 and V2 (with treatment), memory evaluation at V1 (without treatment) and memory evaluation at V1 and V2 (without treatment) in people with Sleep Apnea and Temporo-central Epilepsy, run by Hospices Civils de Lyon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Apnea, Temporo-central Epilepsy, Narcolepsy
- What is being tested?
- memory evaluation at V1 and V2 (with treatment), memory evaluation at V1 (without treatment) and memory evaluation at V1 and V2 (without treatment)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2016to 29 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
France1 site
Service d'exploration et pathologie du sommeil, Hôpital Femme Mère Enfant, 59 Bd Pinel
Lyon, Auvergne-Rhône-Alpes, 69677
About this study
Official title: 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.
- Conditions
- Sleep Apnea, Temporo-central Epilepsy, Narcolepsy, High Intellectual Potential, Healthy Subject
- Being tested
- memory evaluation at V1 and V2 (with treatment), memory evaluation at V1 (without treatment), memory evaluation at V1 and V2 (without treatment)
- Keywords
- Memory, sleep, narcolepsy, apnea, epilepsy
- Medical subject headings
- Sleep Apnea Syndromes, Narcolepsy, Apnea, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
memory evaluation at V1 and V2 (with treatment)Other
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)Other
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)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Other: memory evaluation at V1 and V2 (without treatment) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Memory performances
memory test : Björn Rasch, et al. (2007)
Measured: 6 months
Memory performances
- Mirror drawing test : Nissen, et al. (2006).
Measured: 6 months
Memory performances
- Word- pairs test : Urbain et al. (2011).
Measured: 6 months
Memory performances
- Emotional memory test : Prehn-Kristensen et al. (2009).
Measured: 6 months
Secondary outcomes (22)
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.
Measured: 3 months and 6 months
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.
Measured: 3 months and 6 months
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.
Measured: 3 months and 6 months
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.
Measured: 3 months and 6 months
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.
Measured: 3 months and 6 months
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.
Measured: 3 months and 6 months
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.
Measured: 3 months and 6 months
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.
Measured: 3 months and 6 months
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.
Measured: 3 months and 6 months
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.
Measured: 3 months and 6 months
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.
Measured: 3 months and 6 months
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.
Measured: 3 months and 6 months
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.
Measured: 3 months and 6 months
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.
Measured: 3 months and 6 months
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.
Measured: 3 months and 6 months
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.
Measured: 3 months and 6 months
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.
Measured: 3 months and 6 months
attention assessment
Neuropsychological assessment will be standardized
Measured: 3 months and 6 months
short and long term memory
Neuropsychological assessment will be standardized
Measured: 3 months and 6 months
executive functions
Neuropsychological assessment will be standardized
Measured: 3 months and 6 months
depression and anxiety
Neuropsychological assessment will be standardized
Measured: 3 months and 6 months
Intellectual Quotient
Neuropsychological assessment will be standardized
Measured: 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2016 (estimated)
- Study startFeb 2016
- Primary completion29 May 2018
- Study completion29 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patricia FRANCO, MD PHD, Principal investigator, Service d'exploration et pathologie du sommeil Hôpital Femme Mère Enfant, 59 bd Pinel 69677 BRON Cedex
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02785328
- Sponsor's protocol ID
- 69HCL15_0226
- Acronym
- EnSOM
- Status last verified
- Mar 2019
- First submitted
- 20 May 2016
- Last updated
- 21 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep-dependent Memory Consolidation in Children With Sleep Diseases
- ClinicalTrials.gov ID
- NCT02785328
- Acronym / sponsor ID
- EnSOM / 69HCL15_0226
- Conditions
- Sleep Apnea, Temporo-central Epilepsy, Narcolepsy, High Intellectual Potential, Healthy Subject
- Keywords
- Memory, sleep, narcolepsy, apnea, epilepsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Feb 2016 (actual)
- Primary completion
- 29 May 2018 (actual)
- Study completion
- 29 May 2018 (actual)
- First posted
- 27 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| obstructive sleep apnoea | Experimental | Other: memory evaluation at V1 and V2 (with treatment)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. |
| narcolepsy | Experimental | Other: memory evaluation at V1 and V2 (with treatment)The objective of this task is to evaluate the sleep-dependent consolidation abilities before and after treatment in children suffering from narcolepsy. |
| BECTS (Benign epilepsy with centro-temporal spikes) | Experimental | Other: memory evaluation at V1 and V2 (with treatment)The objective of this task is to evaluate the sleep-dependent consolidation abilities before and after treatment in children suffering from BECTS. |
| high intellectual potential | Experimental | Other: memory evaluation at V1 (without treatment)The objective of this task is to evaluate the sleep-dependent consolidation abilities in children with high intellectual potential. |
| healthy children | Experimental | Other: memory evaluation at V1 and V2 (without treatment)The objective of this task is to evaluate the sleep-dependent consolidation abilities in healthy children. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- aged between 6 and 12 y
- referred to the HFME for a suspicion of sleep apnea
- narcolepsy
- centro-temporal epilepsy
- high intellectual potential
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | BECTS (Benign epilepsy with centro-temporal spikes), narcolepsy, obstructive sleep apnoea |
| 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. | Other | high intellectual potential |
| 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. | Other | healthy children |
Primary outcome
Memory performances
Time frame: 6 months
memory test : Björn Rasch, et al. (2007)
Memory performances
Time frame: 6 months
- Mirror drawing test : Nissen, et al. (2006).
Memory performances
Time frame: 6 months
- Word- pairs test : Urbain et al. (2011).
Memory performances
Time frame: 6 months
- Emotional memory test : Prehn-Kristensen et al. (2009).
22 secondary outcomes
total sleep time (TST)
Time frame: 3 months and 6 months
sleep efficiency (sleep time/time on bed)
Time frame: 3 months and 6 months
sleep latency (time before sleeping after closing eyes)
Time frame: 3 months and 6 months
number of awakenings
Time frame: 3 months and 6 months
number of Stage 1
Time frame: 3 months and 6 months
number of Stage 2
Time frame: 3 months and 6 months
Slow-wave sleep (SWS) percentages
Time frame: 3 months and 6 months
PS percentages
Time frame: 3 months and 6 months
SWS time
Time frame: 3 months and 6 months
PS latency (time between start of sleep and start of PS)
Time frame: 3 months and 6 months
numbers of rapid eye movements
Time frame: 3 months and 6 months
total cycle time (TCT)
Time frame: 3 months and 6 months
TCT/TST ratio
Time frame: 3 months and 6 months
WASO (wake after sleep onset)
Time frame: 3 months and 6 months
apnoea/hypopnoea index
Time frame: 3 months and 6 months
O2 desaturation
Time frame: 3 months and 6 months
micro-arousal index
Time frame: 3 months and 6 months
attention assessment
Time frame: 3 months and 6 months
short and long term memory
Time frame: 3 months and 6 months
executive functions
Time frame: 3 months and 6 months
depression and anxiety
Time frame: 3 months and 6 months
Intellectual Quotient
Time frame: 3 months and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patricia FRANCO, MD PHD principal investigator
Service d'exploration et pathologie du sommeil Hôpital Femme Mère Enfant, 59 bd Pinel 69677 BRON Cedex
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing memory evaluation at V1 and V2 (with treatment), memory evaluation at V1 (without treatment) and memory evaluation at V1 and V2 (without treatment) in people with Sleep Apnea and Temporo-central Epilepsy, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Memory performances (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2019.