Melatonin and Sleep Spindles in Autism

Study Overview
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Brief Summary
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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.

Official Title
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The Effects of Melatonin on Sleep Spindles in Children With Autism

Conditions
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Autism Spectrum Disorder

Intervention / Treatment
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* Dietary Supplement: Melatonin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Melatonin<br>5mg melatonin gummy 30 min before bedtime for 2 consecutive nights | Dietary Supplement: Melatonin<br>* 5mg gummy 30 min before bedtime for 2 consecutive nights<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Melatonin