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Active (not recruiting) Not applicable NCT05716906

Melatonin and Sleep Spindles in Autism

No applicable phase (e.g. observational)
Conditions: Autism Spectrum Disorder

Sponsor: Massachusetts General Hospital

trial.available_in: БГ
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.
Who can participate
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
Interventions
Melatonin
DIETARY_SUPPLEMENT
Locations 1
United States (1)
Massachusetts General Hospital
Boston , Massachusetts
Technical details
Status
Active (not recruiting)
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
12 Years
Maximum age
18 Years
Healthy volunteers
No
Start date
11.01.2023
Completion date
01.01.2027
Registry ID
NCT05716906
Source
clinicaltrials.gov
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