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Melatonin may ease sleepless nights for kids with autism

NCT ID NCT01993251

Symptom relief Sponsor: Hospices Civils de Lyon Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested different doses of melatonin to see which one best improves sleep quality in autistic children aged 3 to 12 who have trouble sleeping. Researchers measured things like how long it takes to fall asleep, total sleep time, and number of night awakenings using sleep monitors and questionnaires. The goal was to find the most effective dose to help these children sleep more soundly.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

26 people

The number who actually took part.

Started

Jun 2014

Finished

Jun 2018

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

3 to 12 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

autism spectrum disorder sleep-wake disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Sleep disorders

Contacts and locations

Locations

  • CHRU de Strasbourg

    Strasbourg, 67091, France

  • CHU de Caen

    Caen, 14033, France

  • CHU de Tours

    Tours, 37044, France

  • Centre Hospitalier du Chinonais

    Chinon, France

  • Hôpital Femme Mere Enfant

    Bron, 69677, France

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