Melatonin and Sleep Spindles in Autism

NCT ID: NCT05716906

Last Updated: 2025-09-10

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-11
• Study Completion Date: 2025-12-31

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.

Conditions

Autism Spectrum Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Melatonin

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

Group Type: EXPERIMENTAL

Melatonin

Intervention Type: DIETARY_SUPPLEMENT

5mg gummy 30 min before bedtime for 2 consecutive nights

Interventions

Melatonin

5mg gummy 30 min before bedtime for 2 consecutive nights

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Dara S. Manoach, PhD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dara Manoach, PhD

Role: PRINCIPAL_INVESTIGATOR

Professor

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2021P002832

Identifier Type: -

Identifier Source: org_study_id