NCT05716906Active, not recruiting
Melatonin and Sleep Spindles in Autism
The Effects of Melatonin on Sleep Spindles in Children With Autism
Source: ClinicalTrials.gov · Last updated 20 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 30 Jan 2023
- Start date
- 11 Jan 2023
- Primary completion date
- 5 Jun 2024
- Lead sponsor
- Massachusetts General Hospital
- Diseases
- Autism
- NCT number
- NCT05716906
What you commit to
- Study type: Interventional
- Planned participants: 30
- From 11 Jan 2023 to the primary completion date, 5 Jun 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently taking melatonin or those who have had an adverse reaction to melatonin in the past
Other illness
- 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
- Other neurological disorder, including seizure disorder
- Diagnosed sleep disorder
Other
- Pregnant or breastfeeding
- Substance abuse or dependence within the past six months (nicotine abuse or dependence is not exclusionary)
- IQ \<70
- Known genetic causes of ASD
Who the study is looking for
- Male and female subjects with ASD
- 12-18 years of age
- English speaking
- Able to understand and respond to questionnaires in English
Age in the registry: 12 years to 18 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.