Melatonin and Sleep Spindles in Autism

Last updated: September 30, 2024
Sponsor: Massachusetts General Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Autism

Asperger's Disorder

Autism Spectrum Disorder (Asd)

Treatment

Melatonin

Clinical Study ID

NCT05716906
2021P002832
  • Ages 12-18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Pregnant or breastfeeding

  • Substance abuse or dependence within the past six months (nicotine abuse ordependence is not exclusionary)

  • Chronic medical conditions that affect sleep

  • Any unstable chronic medical condition such as asthma, diabetes, cystic fibrosis, orcardiac disease

  • History of head injury resulting in prolonged loss of consciousness or otherneurological 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 inthe past

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: Melatonin
Phase:
Study Start date:
January 01, 2023
Estimated Completion Date:
June 30, 2025

Connect with a study center

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

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