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Recruiting NCT05716906

Melatonin and Sleep Spindles in Autism

Conditions: Autism Spectrum Disorder

Sex: All
Ages: 12 Years – 18 Years
Phase: NA
Enrollment: 30
Sponsor: Massachusetts General Hospital

Location: United States

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 Criteria:Male and female subjects with ASD12-18 years of ageEnglish speakingAble to understand and respond to questionnaires in EnglishExclusion Criteria:Pregnant or breastfeedingSubstance abuse or dependence within the past six months (nicotine abuse or dependence is not exclusionary)Chronic medical conditions that affect sleepAny unstable chronic medical condition such as asthma, diabetes, cystic fibrosis, or cardiac diseaseHistory of head injury resulting in prolonged loss of consciousness or other neurological sequelaeIQ <70Other neurological disorder, including seizure disorderDiagnosed sleep disorderKnown genetic causes of ASDCurrently taking melatonin or those who have had an adverse reaction to melatonin in the past

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05716906). StuddyBuddy aggregates publicly available trial information.