Do Sleep and Circadian Rhythm Disturbances Impact the Cognitive and Behavioural Development of Children With Autism?
NCT ID: NCT02878499
Last Updated: 2022-06-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
105 participants
INTERVENTIONAL
2012-12-19
2023-02-28
Brief Summary
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This innovative study will use objective quantifiable measures of sleep and circadian rhythms in addition to subjective measures.
The investigators aim to assess the hypotheses that, in pre-pubertal children with ASD,
1. sleep disturbances are correlated with circadian rhythm disturbances;
2. both sleep and circadian rhythm disturbances are negatively correlated with cognitive performance and positively correlated with behavioural disturbances;
3. sleep and circadian rhythm disturbances, most notably abnormal melatonin secretion, impact the cognitive and behavioural development of children with ASD, depending on age (prospective longitudinal analyses).
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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ASD
polysomnography
Interventions
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polysomnography
Eligibility Criteria
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Inclusion Criteria
* Diagnostic criteria of autism spectrum disorder (ASD)
* Autism Diagnostic Interview (ADI) - revised (R) score compatible with ASD diagnosis
* Autism Diagnostic Observation Schedule (ADOS) score compatible with ASD diagnosis
* Study information has been understood
* Study consent signed by both parents or legal representatives and by the child if the child is capable of expressing his consent
Exclusion Criteria
* Priori clinical medical examination
* Child affiliated with social security Concerning sleep disorders: the discovery of a primary sleep disorder (e.g.: sleep apnea syndrome, restless legs syndrome, periodic limb movements during sleep) as well as their treatment is not a criteria for terminating the study but will be taken into account in data analysis
* Secondary autism: e.g. associated with Rett syndrome, fragile X syndrome, Down syndrome, Bourneville tuberous sclerosis, von Recklinghausen disorder, Cytomegalovirus (CMV) encephalitis, congenital rubeola, phenylketonuria.
* Current treatment with melatonin or melatonin agonists before study entry (before baseline assessment)
* Transmeridian travel (\> 2 time zones) in the month preceding the study
* Participation in other research studies in the 3 months period preceding the study
* Treatment with betablockers, local or systemic non-steroidal anti-inflammatory (NSAI) agents, benzodiazepines, antidepressants
* Severe other intercurrent disorder.
* Severe allergies.
3 Years
8 Years
ALL
No
Sponsors
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University Hospital, Strasbourg, France
OTHER
Responsible Party
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Locations
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CHRU de Lille - Hôpital Roger Salengro
Lille, , France
CHU de Lyon - CHS Le Vinatier
Lyon, , France
CHU Gui de Chaulhiac
Montpellier, , France
Hôpitaux Universitaires de Strasbourg
Strasbourg, , France
CHU de TOURS - Hôpital Bretonneau
Tours, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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5060
Identifier Type: -
Identifier Source: org_study_id
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