Melatonin and Sleep Spindles in Autism

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Autism Spectrum Disorder
• Intervention / Treatment: Dietary supplement: Melatonin

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Melatonin; 5mg melatonin gummy 30 min before bedtime for 2 consecutive nights	Dietary supplement: Melatonin; 5mg gummy 30 min before bedtime for 2 consecutive nights

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Five nights of sleep over two weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in sleep quality	Change in sleep quality between baseline and melatonin nights	Five nights of sleep over two weeks

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Investigators: Principal Investigator: Dara Manoach, PhD, Professor

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2023
• Primary Completion (Actual): June 5, 2024
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: January 30, 2023
• First Submitted That Met QC Criteria: January 30, 2023
• First Posted (Actual): February 8, 2023

Study Record Updates

• Last Update Posted (Actual): April 20, 2026
• Last Update Submitted That Met QC Criteria: April 15, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Melatonin
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indoles; Tryptamines; Melatonin
• Other Study ID Numbers: 2021P002832

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Data will be available following the publication of the results.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No