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Can melatonin fix sleep problems in autism? new study investigates brain waves

NCT ID NCT05716906

Knowledge-focused Sponsor: Massachusetts General Hospital 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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looks at whether melatonin, a common sleep aid, can improve sleep spindles—special brain waves that help with sleep and attention—in 30 children with autism aged 12-18. Researchers want to understand why sleep and sensory issues happen in autism and test if melatonin can help. The study uses a portable EEG device to measure brain activity during sleep.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2023

Expected to finish

Jan 2027

An estimate. End dates often move.

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

12 to 18 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: * Male and female subjects with ASD * 12-18 years of age * English speaking * Able to understand and respond to questionnaires in English Exclusion Criteria: * Pregnant or breastfeeding * Substance abuse or dependence within the past six months (nicotine abuse or dependence is not exclusionary) * Chronic medical conditions that affect sleep * Any unstable chronic medical condition such as asthma, diabetes, cystic fibrosis, or cardiac disease * History of head injury resulting in prolonged loss of consciousness or other neurological sequelae * IQ \<70 * Other neurological disorder, including seizure disorder * Diagnosed sleep disorder * Known genetic causes of ASD * Currently taking melatonin or those who have had an adverse reaction to melatonin in the past

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Conditions

The condition(s) this trial relates to.

autism spectrum disorder

As listed by the trial registrant

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

Autism spectrum disorder

Contacts and locations

Locations

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.