Sleep Disorders Clinical Trial
Official title:
Does Melatonin Restore Sleep Architecture in Autistic Children?
Although behavioral disorders origins in autistic children are still unclear, they seem to be
influenced by sleep disorders. Results of studies performed on sleep quality in autistic
children showed a high prevalence of sleep disorders in these children, estimated between 50
and 80% compared to children with typical development and insomnia is one of the sleep
disorders most frequently reported by autistic children's parents. Others studies showed
circadian rhythm disorder in autistic children which could be the consequence of genetic
abnormalities in the melatonin synthesis and the melatonin role in the synaptic transmission
modulation.
Melatonin by its sedative effects and its action on circadian pacemaker is a promoter of
sleep proposed for insomnia treatment and circadian rhythm disorders.
Two major recent studies (not yet published) in the United States and in England seek to show
the effectiveness of melatonin by testing the effects of three doses of melatonin on reducing
sleep disorders.
It is therefore interesting and important to conduct a parallel study to assess the melatonin
effect not only on the reduction of sleep disorders (sleep onset latency, total sleep time…),
but on sleep quality (number of nocturnal awakenings).
The strength of this study lies in the combination of several measurement tools to assess the
melatonin dose-effect on all parameters in both physiological (actimetrics, polysomnography),
biological (dosage 24h sulfatoxymelatonin), behavioral (sleep questionnaire, index of
insomnia severity, rating scale autistic disorder) as well as possible side effects.
The primary objective is to determine the most effective dose of melatonin to improve sleep
quality in autistic children.
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