Melatonin and Sleep Spindles in Autism

Overview

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.

Full Title of Study: “The Effects of Melatonin on Sleep Spindles in Children With Autism”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Basic Science
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 30, 2024

Interventions

  • Dietary Supplement: Melatonin
    • 5mg gummy 30 min before bedtime for 2 consecutive nights

Arms, Groups and Cohorts

  • Experimental: Melatonin
    • 5mg melatonin gummy 30 min before bedtime for 2 consecutive nights

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Change in sleep quality
    • Time Frame: Five nights of sleep over two weeks
    • Change in sleep quality between baseline and melatonin nights

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 12 Years

Maximum Age: 18 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Massachusetts General Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Dara S. Manoach, PhD, Professor – Massachusetts General Hospital
  • Overall Official(s)
    • Dara Manoach, PhD, Principal Investigator, Professor
  • Overall Contact(s)
    • Dara Manoach, PhD, 617-724-6148, manoachlab@gmail.com

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.