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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
26
one capsule, melatonin 0.5 mg, oral, once a day, 30 minutes before bedtime
one capsule, melatonin 2 mg, oral, once a day, 30 minutes before bedtime
one capsule, melatonin 6 mg, oral, once a day, 30 minutes before bedtime
one capsule, placebo, oral, once a day, 30 minutes before bedtime
Hôpital Femme Mere Enfant
Bron, France
CHU de Caen
Caen, France
Centre Hospitalier du Chinonais
Chinon, France
CHRU de Strasbourg
Strasbourg, France
CHU de Tours
Tours, France
To determine the most effective dose of melatonin to improve sleep quality in autistic children.
The primary outcome is to measure the awakenings index which is the number of nocturnal awakenings higher than 15 seconds per hour of sleep measured by polysomnography.
Time frame: The primary outcome will be assessed once at V2 (D29 +/- 7days) by polysomnography.
To assess in autistic children the melatonin effects on sleep characteristics
by measuring the sleep latency
Time frame: It will be assessed once at V2 (D29 +/- 7 days) by polysomnography and actimetrics.
To assess the effectiveness of treatment on sleep disorders.
It is to evaluate the effectiveness with the scale treatment response, the sleep questionnaire and severity index of insomnia
Time frame: It will be assessed once at V2 (D29 +/- 7 days) by polysomnography and actimetrics.
To assess the effectiveness of melatonin on daytime autistic behavior
Evaluate the effectiveness with the rating scale autistic behavior.
Time frame: It will be assessed three times at V1 (D0), V2 (D29 +/- 7 days) and V4 (D44+/-7days).
To assess the melatonin safety in autistic children.
Evaluate the safety with Adverse events report.
Time frame: It will be assessed three times at V2 (D29 +/- 7 days), V3(D30) and V4 (D44+/-7days).
Establish whether there is a correlation between sleep quality and melatonin secretion.
With the urinary melatonin dosage.
Time frame: It will be assessed twice at V3 (D30) and V4 (D44+/-7days).
To assess in autistic children the melatonin effects on sleep characteristics.
by measuring the indexes arousals
Time frame: at V2 (D29 +/- 7 days) by polysomnography and actimetrics.
To assess in autistic children the melatonin effects on sleep characteristics.
by measuring time and percentage of different stages of NREM (Non rapid eye movement) and REM sleep
Time frame: at V2 (D29 +/- 7 days) by polysomnography and actimetrics.
To assess in autistic children the melatonin effects on sleep characteristics
by measuring the density of sleep spindles in light NREM sleep
Time frame: at V2 (D29 +/- 7 days) by polysomnography and actimetrics
To assess in autistic children the melatonin effects on sleep characteristics
by measuring the density of eye movements REM sleep.
Time frame: at V2 (D29 +/- 7 days) by polysomnography and actimetrics.
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