Melatonin and Sleep Spindles in Autism

NCT05716906 | Active Not Recruiting

• 1 other identifier: 2021P002832
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder

Keywords

Melatonin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in sleep quality

  Five nights of sleep over two weeks

Study Arms (1)

Melatonin

EXPERIMENTAL

5mg melatonin gummy 30 min before bedtime for 2 consecutive nights

Dietary Supplement: Melatonin

Interventions

Melatonin DIETARY_SUPPLEMENT

5mg gummy 30 min before bedtime for 2 consecutive nights

Melatonin

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Male and female subjects with ASD
• years of age
• English speaking
• Able to understand and respond to questionnaires in English

You may not qualify if:

• Pregnant or breastfeeding
• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Dara Manoach, PhD

  Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 30, 2023
• First Posted: February 8, 2023
• Study Start: January 11, 2023
• Primary Completion: June 5, 2024
• Study Completion (Estimated): January 1, 2027
• Last Updated: April 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be available following the publication of the results.

Locations

US (1)