Sleep DisordersPhase 2SOMELIANCT01993251
Does Melatonin Restore Sleep Architecture in Autistic Children
A Phase 2 study testing melatonin in people with Sleep Disorders, run by Hospices Civils de Lyon at 5 sites in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Sleep Disorders
- What is being tested?
- melatonin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 5 sitesFrance
- Study dates
- Jun 2014to 12 Jun 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Hôpital Femme Mere Enfant
Bron, 69677
CHU de Caen
Caen, 14033
Centre Hospitalier du Chinonais
Chinon
CHRU de Strasbourg
Strasbourg, 67091
CHU de Tours
Tours, 37044
About this study
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.
Read more
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.
- Conditions
- Sleep Disorders
- Being tested
- melatonin, placebo
- Keywords
- sleep,melatonin,autism,children
- Medical subject headings
- Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
melatoninDrug
one capsule, melatonin 0.5 mg, oral, once a day, 30 minutes before bedtime
MelatoninDrug
one capsule, melatonin 2 mg, oral, once a day, 30 minutes before bedtime
MelatoninDrug
one capsule, melatonin 6 mg, oral, once a day, 30 minutes before bedtime
placeboDrug
one capsule, placebo, oral, once a day, 30 minutes before bedtime
| Study group | Role | What they receive |
|---|---|---|
| melatonin 0.5mg | Active comparator | Not described Receives: Drug: melatonin |
| melatonin 2mg | Active comparator | Not described Receives: Drug: Melatonin |
| melatonin 6mg | Active comparator | Not described Receives: Drug: Melatonin |
| placebo | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The primary outcome will be assessed once at V2 (D29 +/- 7days) by polysomnography.
Secondary outcomes (9)
To assess in autistic children the melatonin effects on sleep characteristics
by measuring the sleep latency
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: at V2 (D29 +/- 7 days) by polysomnography and actimetrics.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startJun 2014
- Primary completion12 Jun 2018
- Study completion12 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep DisordersStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patricia Franco, MD, Principal investigator, CHU Hôpital Femme Mère Enfant.Bron
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01993251
- Sponsor's protocol ID
- 2012-732
- Other IDs
- 2013-001230-17
- Acronym
- SOMELIA
- Status last verified
- Sep 2025
- First submitted
- 13 Nov 2013
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Effects of immediate melatonin on sleep and behavior in children with autism SOMELIA study Guyon A, Comajuan M, Limousin N, Trippi, Schröder C, Plancoulaine S, Franco P The 21st International Congress of the ESCAP - Beyond nature & nurture Strasbourg, France, 29/06/2025 - 01/07/2025
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Melatonin Restore Sleep Architecture in Autistic Children?
- ClinicalTrials.gov ID
- NCT01993251
- Acronym / sponsor ID
- SOMELIA / 2012-732
- Conditions
- Sleep Disorders
- Keywords
- sleep,melatonin,autism,children
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Jun 2014 (actual)
- Primary completion
- 12 Jun 2018 (actual)
- Study completion
- 12 Jun 2018 (actual)
- First posted
- 25 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| melatonin 0.5mg | Active comparator | Drug: melatonin |
| melatonin 2mg | Active comparator | Drug: Melatonin |
| melatonin 6mg | Active comparator | Drug: Melatonin |
| placebo | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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),
Key exclusion criteria (8 listed)
- 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),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| melatoninone capsule, melatonin 0.5 mg, oral, once a day, 30 minutes before bedtime | Drug | melatonin 0.5mg |
| Melatoninone capsule, melatonin 2 mg, oral, once a day, 30 minutes before bedtime | Drug | melatonin 2mg |
| Melatoninone capsule, melatonin 6 mg, oral, once a day, 30 minutes before bedtime | Drug | melatonin 6mg |
| placeboone capsule, placebo, oral, once a day, 30 minutes before bedtime | Drug | placebo |
Primary outcome
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.
9 secondary outcomes
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.
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.
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).
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).
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).
To assess in autistic children the melatonin effects on sleep characteristics.
Time frame: at V2 (D29 +/- 7 days) by polysomnography and actimetrics.
To assess in autistic children the melatonin effects on sleep characteristics.
Time frame: at V2 (D29 +/- 7 days) by polysomnography and actimetrics.
To assess in autistic children the melatonin effects on sleep characteristics
Time frame: at V2 (D29 +/- 7 days) by polysomnography and actimetrics
To assess in autistic children the melatonin effects on sleep characteristics
Time frame: at V2 (D29 +/- 7 days) by polysomnography and actimetrics.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
- Results publicationEffects of immediate melatonin on sleep and behavior in children with autism SOMELIA study Guyon A, Comajuan M, Limousin N, Trippi, Schröder C, Plancoulaine S, Franco P The 21st International Congress of the ESCAP - Beyond nature & nurture Strasbourg, France, 29/06/2025 - 01/07/2025
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patricia Franco, MD principal investigator
CHU Hôpital Femme Mère Enfant.Bron
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing melatonin in people with Sleep Disorders, run by Hospices Civils de Lyon at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01993251, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2025.