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NCT Number: NCT05716906

Melatonin and Sleep Spindles in 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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Autism Spectrum Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

melatonin

Dietary Supplement

5mg gummy 30 min before bedtime for 2 consecutive nights

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change in sleep quality

    Time frame: Five nights of sleep over two weeks

    Change in sleep quality between baseline and melatonin nights

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

The Effects of Melatonin on Sleep Spindles in Children With Autism

Important dates

Study start
2023
Primary completion
2024
Study completion
2027
First posted
Feb 8, 2023
Registry last updated
Apr 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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