Do Sleep and Circadian Rhythm Disturbances Impact the Cognitive and Behavioural Development of Children With Autism?

U

University Hospital, Strasbourg, France

Status

Enrolling

Conditions

Autism Spectrum Disorder

Treatments

Other: polysomnography

Study type

Interventional

Funder types

Other

Identifiers

NCT02878499
5060

Details and patient eligibility

About

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, sleep disturbances are correlated with circadian rhythm disturbances; both sleep and circadian rhythm disturbances are negatively correlated with cognitive performance and positively correlated with behavioural disturbances; 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).

Enrollment

105 estimated patients

Sex

All

Ages

3 to 8 years old

Volunteers

No Healthy Volunteers

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

Exclusion criteria

  • 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.

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

105 participants in 1 patient group

ASD
Other group
Treatment:
Other: polysomnography

Trial contacts and locations

0

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Central trial contact

Carmen SCHRODER, MD,PhD

Data sourced from clinicaltrials.gov

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