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Melatonin and Sleep Spindles in Autism

The Effects of Melatonin on Sleep Spindles in Children With Autism

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05716906
Enrollment
30
Registered
2023-02-08
Start date
2023-01-11
Completion date
2027-01-01
Last updated
2026-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism Spectrum Disorder

Keywords

Melatonin

Brief 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. 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.

Interventions

DIETARY_SUPPLEMENTMelatonin

5mg gummy 30 min before bedtime for 2 consecutive nights

Sponsors

Massachusetts General Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in sleep spindle densityFive nights of sleep over two weeksChanges in sleep spindle density (#/min) during non-Rapid Eye Movement (NREM) sleep between baseline and melatonin nights as measured by portable EEG device.

Secondary

MeasureTime frameDescription
Change in sleep qualityFive nights of sleep over two weeksChange in sleep quality between baseline and melatonin nights

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORDara Manoach, PhD

Professor

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 21, 2026