Melatonin and Sleep Spindles in Autism

Mass General Brigham

Status: Active, not recruiting

Conditions: Autism Spectrum Disorder

Treatments: Dietary Supplement: Melatonin

Study type: Interventional

Funder types: Other

Identifiers

NCT05716906

2021P002832

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 12 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Melatonin

Experimental group

Description:

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

Treatment:

Dietary Supplement: Melatonin