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NCT Number: NCT01993251

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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Key information

Conditions

Sleep Disorders Mental Disorders Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Wake Disorders

Age range

3 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hôpital Femme Mere Enfant, Bron, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Boys and girls from 3 to 12 years old with autism spectrum,
  • Diagnosed by psychiatrists according to the diagnostic criteria for autism ICD-10 AND ADI or ADOS positive,
  • With trouble sleeping, assessed by questionnaire CHSQ,
  • Having made a night polysomnography,
  • Written informed consent (signed by parents),
  • Affiliated with the French universal healthcare system.

Exclusion criteria

  • Children who stopped all treatment for sleep for less than one month,
  • Liver or kidney insufficiencies,
  • Acute illness during or occurred in the month preceding the study,
  • Neurological disease without autism spectrum , patients with non-controlled epilepsy
  • Health background witch can influence sleep (other than autism itself),
  • Obstructive syndrome (history - oral breathing in wakefulness, nocturnal snoring significant (heard the door closed), nocturnal respiratory effort, apnea reported by parents- and clinical examination (chronic nasal congestion, large tonsils and touching),
  • Known hypersensitivity to the active substance or to one of the excipient contained in the verum or in the placebo,
  • Children under treatment against-indicated with the study treatment witch can't be stopped

Treatment and study plan

Melatonin

Drug

one capsule, melatonin 0.5 mg, oral, once a day, 30 minutes before bedtime

Placebo

Drug

one capsule, placebo, oral, once a day, 30 minutes before bedtime

Primary outcomes

  1. To determine the most effective dose of melatonin to improve sleep quality in autistic children.

    Time frame: The primary outcome will be assessed once at V2 (D29 +/- 7days) by polysomnography.

    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.

Secondary outcomes

  1. To assess in autistic children the melatonin effects on sleep characteristics

    Time frame: It will be assessed once at V2 (D29 +/- 7 days) by polysomnography and actimetrics.

    by measuring the sleep latency

  2. To assess the effectiveness of treatment on sleep disorders.

    Time frame: It will be assessed once at V2 (D29 +/- 7 days) by polysomnography and actimetrics.

    It is to evaluate the effectiveness with the scale treatment response, the sleep questionnaire and severity index of insomnia

  3. To assess the effectiveness of melatonin on daytime autistic behavior

    Time frame: It will be assessed three times at V1 (D0), V2 (D29 +/- 7 days) and V4 (D44+/-7days).

    Evaluate the effectiveness with the rating scale autistic behavior.

  4. To assess the melatonin safety in autistic children.

    Time frame: It will be assessed three times at V2 (D29 +/- 7 days), V3(D30) and V4 (D44+/-7days).

    Evaluate the safety with Adverse events report.

  5. Establish whether there is a correlation between sleep quality and melatonin secretion.

    Time frame: It will be assessed twice at V3 (D30) and V4 (D44+/-7days).

    With the urinary melatonin dosage.

  6. To assess in autistic children the melatonin effects on sleep characteristics.

    Time frame: at V2 (D29 +/- 7 days) by polysomnography and actimetrics.

    by measuring the indexes arousals

  7. To assess in autistic children the melatonin effects on sleep characteristics.

    Time frame: at V2 (D29 +/- 7 days) by polysomnography and actimetrics.

    by measuring time and percentage of different stages of NREM (Non rapid eye movement) and REM sleep

  8. To assess in autistic children the melatonin effects on sleep characteristics

    Time frame: at V2 (D29 +/- 7 days) by polysomnography and actimetrics

    by measuring the density of sleep spindles in light NREM sleep

  9. To assess in autistic children the melatonin effects on sleep characteristics

    Time frame: at V2 (D29 +/- 7 days) by polysomnography and actimetrics.

    by measuring the density of eye movements REM sleep.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Does Melatonin Restore Sleep Architecture in Autistic Children?

Acronym: SOMELIA

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Nov 25, 2013
Registry last updated
Oct 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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