Autism Spectrum DisorderNCT05716906
Melatonin and Sleep Spindles in Autism
A study testing Melatonin in people with Autism Spectrum Disorder, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
Sleep disturbances and sensory sensitivities are common disabling features of autism, but their underlying causes are not clear. We hypothesize that both of these difficulties reflect disrupted communication between a deep brain structure, the thalamus, and the brain's outer layer, the cortex. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Melatonin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jan 2023to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Male and female subjects with ASD
- 12-18 years of age
- English speaking
- Able to understand and respond to questionnaires in English
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: The Effects of Melatonin on Sleep Spindles in Children With Autism
Sleep disturbances and sensory sensitivities are common disabling features of autism, but their underlying causes are not clear. We hypothesize that both of these difficulties reflect disrupted communication between a deep brain structure, the thalamus, and the brain's outer layer, the cortex. This communication is mediated by the thalamic reticular nucleus (TRN). Due to its small size and location deep in the brain, we cannot assess TRN function without invasive techniques. Fortunately, sleep spindles, a specific brain rhythm provide a noninvasive read-out of TRN function. In Aim 1 we will examine whether reduced sleep spindles are related to worse sleep quality, impaired selective attention during wake, and sensory sensitivities in children with autism. In Aim 2, we will determine whether melatonin, which is commonly used to improve sleep, also increases sleep spindles in autism. If successful, this study will introduce TRN as a target for treatment of sleep disruption and guide larger home-based sleep studies.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Melatonin
- Keywords
- Melatonin
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MelatoninDietary supplement
5mg gummy 30 min before bedtime for 2 consecutive nights
| Study group | Role | What they receive |
|---|---|---|
| Melatonin | Experimental | 5mg melatonin gummy 30 min before bedtime for 2 consecutive nights Receives: Dietary Supplement: Melatonin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in sleep spindle density
Changes in sleep spindle density (#/min) during non-Rapid Eye Movement (NREM) sleep between baseline and melatonin nights as measured by portable EEG device.
Measured: Five nights of sleep over two weeks
Secondary outcomes (1)
Change in sleep quality
Change in sleep quality between baseline and melatonin nights
Measured: Five nights of sleep over two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start11 Jan 2023
- Primary completion5 Jun 2024
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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 N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dara S. Manoach, PhD, Massachusetts General Hospital
- Investigators
- Dara Manoach, PhD, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05716906
- Sponsor's protocol ID
- 2021P002832
- Status last verified
- Mar 2026
- First submitted
- 30 Jan 2023
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The PI will disseminate results through presentations at public lectures, scientific institutions and meetings, and/or publications in major journals. Specifically, quality-controlled data used in publications will be deidentified and made available to requesting scientists, after publication of the results. Workflows will be documented and will allow any external groups to reproduce results from the raw data.
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Melatonin on Sleep Spindles in Children With Autism
- ClinicalTrials.gov ID
- NCT05716906
- Acronym / sponsor ID
- 2021P002832
- Conditions
- Autism Spectrum Disorder
- Keywords
- Melatonin
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 11 Jan 2023 (actual)
- Primary completion
- 5 Jun 2024 (actual)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 8 Feb 2023 (actual)
- 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.
Sleep disturbances and sensory sensitivities are common disabling features of autism, but their underlying causes are not clear. We hypothesize that both of these difficulties reflect disrupted communication between a deep brain structure, the thalamus, and the brain's outer layer, the cortex. This communication is mediated by the thalamic reticular nucleus (TRN). Due to its small size and location deep in the brain, we cannot assess TRN function without invasive techniques. Fortunately, sleep spindles, a specific brain rhythm provide a noninvasive read-out of TRN function. In Aim 1 we will examine whether reduced sleep spindles are related to worse sleep quality, impaired selective attention during wake, and sensory sensitivities in children with autism. In Aim 2, we will determine whether melatonin, which is commonly used to improve sleep, also increases sleep spindles in autism. If successful, this study will introduce TRN as a target for treatment of sleep disruption and guide larger home-based sleep studies.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Melatonin | Experimental | Dietary Supplement: Melatonin5mg melatonin gummy 30 min before bedtime for 2 consecutive nights |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Male and female subjects with ASD
- 12-18 years of age
- English speaking
- Able to understand and respond to questionnaires in English
Key exclusion criteria (10 listed)
- 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
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 |
|---|---|---|
| Melatonin5mg gummy 30 min before bedtime for 2 consecutive nights | Dietary supplement | Melatonin |
Primary outcome
Change in sleep spindle density
Time frame: Five nights of sleep over two weeks
Changes in sleep spindle density (#/min) during non-Rapid Eye Movement (NREM) sleep between baseline and melatonin nights as measured by portable EEG device.
1 secondary outcome
Change in sleep quality
Time frame: Five nights of sleep over two weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Individual participant dataSharing planned: Yes. The PI will disseminate results through presentations at public lectures, scientific institutions and meetings, and/or publications in major journals. Specifically, quality-controlled data used in publications will be deidentified and made available to requesting scientists, after publication of the results. Workflows will be documented and will allow any external groups to reproduce results from the raw data.
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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.
Dara Manoach, PhD principal investigator
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Melatonin in people with Autism Spectrum Disorder, run by Massachusetts General Hospital at 1 site in United States.
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 4 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Change in sleep spindle density (time frame: Five nights of sleep over two weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Apr 2026.