Informations générales (source: ClinicalTrials.gov)
Do Sleep and Circadian Rhythm Disturbances Impact the Cognitive and Behavioural Development of Children With Autism?
Interventional
N/A
University Hospital, Strasbourg, France (Voir sur ClinicalTrials)
décembre 2012
février 2023
29 juin 2024
The primary objective of this study is to undertake a longitudinal investigation of the
impact of sleep and circadian rhythm disturbances on cognitive and behavioural
trajectories in children with autism spectrum disorder (ASD) age 3-10 years old.
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).
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHRU de Lille - Hôpital Roger Salengro - 59037 - Lille - France | Jean-Louis GOEB, MD | Contact (sur clinicalTrials) | |||
| CHU de TOURS - Hôpital Bretonneau - 37044 - Tours - France | Frédérique BONNET-BRILHAULT | Contact (sur clinicalTrials) | |||
| CHU Gui de Chaulhiac - 34295 - Montpellier - France | Amaria BAGHDADLI | Contact (sur clinicalTrials) | |||
| Hôpitaux Universitaires de Strasbourg - 67091 - Strasbourg - France | Carmen Schröder, MD, PhD | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CHU de Lyon - CHS Le Vinatier - 69100 - Lyon - France | Nicolas GEORGIEFF | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion criteria:
- Age: from 3 to 8 years of age at inclusion, as per defined entry ages (longitudinal
accelerated design)
- 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
- Stable medication over the 2 months-period preceding inclusion and during evaluation
periods (exception: (1) medication mentioned in the exclusion criteria, (2) a new
medication instaurated between two evaluation periods is not in itself an exclusion
criteria, but will be taken into account in data analysis)
- Compliance with study procedures
- 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
- Age: from 3 to 8 years of age at inclusion, as per defined entry ages (longitudinal
accelerated design)
- 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
- Stable medication over the 2 months-period preceding inclusion and during evaluation
periods (exception: (1) medication mentioned in the exclusion criteria, (2) a new
medication instaurated between two evaluation periods is not in itself an exclusion
criteria, but will be taken into account in data analysis)
- Compliance with study procedures
- 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)
- Changes in medication over the 2 months-period preceding the study (exception: a new
medication instaurated between two evaluation periods is not in itself an exclusion
criteria, but will be taken into account in data analysis)
- 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.