Melatonin and Sleep Spindles in Autism

Not Applicable

Recruiting

• Conditions: Autism Spectrum Disorder
• Interventions: Dietary Supplement: Melatonin

• Registration Number: NCT05716906
• Lead Sponsor: Massachusetts General Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-01
• Study First Submitted: 2023-01-30
• Study First Submitted QC: 2023-01-30
• Study First Posted: 2023-02-08
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-30
• Last Update Posted: 2024-10-02
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Melatonin	Melatonin	5mg melatonin gummy 30 min before bedtime for 2 consecutive nights

Primary Outcome Measures

Name	Time	Method
Change in sleep spindle density	Five nights of sleep over two weeks	Changes in sleep spindle density (#/min) during non-Rapid Eye Movement (NREM) sleep between baseline and melatonin nights as measured by portable EEG device.

Secondary Outcome Measures

Name	Time	Method
Change in sleep quality	Five nights of sleep over two weeks	Change in sleep quality between baseline and melatonin nights

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States